title: Phase III Randomized Trial of Atezolizumab in Elderly Patients With Advanced Non-Small-Cell Lung Cancer and Receiving Monthly Carboplatin With Weekly Paclitaxel Chemotherapy

acronym: ELDERLY

summary: Non Small Cell Lung Cancer (NSCLC) remains the leading cause of death by cancer in the world. Because of the increase in lung cancer incidence with age and the increase of life expectancy, about half of the patients are patients aged 70 or older. Several clinical trials have shown the interest of adding immunotherapy to standard 1st line chemotherapy in NSCLC. Although in these studies there was not necessarily a higher age limit, in fact the proportion of included patients aged 75 or older remains low (between 7 and 10%). It is therefore necessary to conduct a trial dedicated to these patients in order to determine whether immunotherapy is as effective and tolerated as in the general population.

ReferenceCitation: Quoix E, Zalcman G, Oster JP, Westeel V, Pichon E, Lavole A, Dauba J, Debieuvre D, Souquet PJ, Bigay-Game L, Dansin E, Poudenx M, Molinier O, Vaylet F, Moro-Sibilot D, Herman D, Bennouna J, Tredaniel J, Ducolone A, Lebitasy MP, Baudrin L, Laporte S, Milleron B; Intergroupe Francophone de Cancerologie Thoracique. Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial. Lancet. 2011 Sep 17;378(9796):1079-88. doi: 10.1016/S0140-6736(11)60780-0. Epub 2011 Aug 8.

location_facility: Villefranche-Sur-Saône - Hôpital Nord-Ouest

location_facility: Nancy - Institut de Cancérologie de Lorraine

location_facility: Quint-Fonsegrives - Clinique de la Croix du Sud

location_facility: Saint-Priest - Institut de Cancérologie de la Loire


study_start_date_type: Actual

acronym: TOPICAL

intervention_type: Drug

lead_sponsor: University Hospital, Tours

summary: Cutaneous microcystic lymphatic malformations (CMLMs) are rare conditions of children and adults resulting from abnormal embryologic development of lymphatic vessels. They present as clusters of vesicles full of lymph and blood of various extent. They ooze and bleed, inducing maceration, esthetic impairment, scars, pain, bacterial infections and impaired quality of life. Currently, treatments for CMLMs are disappointing, and their management is challenging. Sirolimus is an inhibitor of mammalian target of rapamycin (mTOR), a serine/threonine protein kinase involved in cell growth and proliferation, cellular metabolism, autophagy and angio-lymphangiogenesis. Topical sirolimus, known to be efficient and well tolerated in cutaneous angiofibromas linked to tuberous sclerosis, has recently been reported effective in few reports of patients with CMLMs. The objective of this trial is to compare the efficacy and safety of a 12-week application of 0.1% topical sirolimus versus topical vehicle in CMLMs in children and adults.

ReferenceType: derived

ReferenceCitation: Leducq S, Caille A, Barbarot S, Beneton N, Bessis D, Boccara O, Bursztejn AC, Chiaverini C, Dompmartin A, Droitcourt C, Gissot V, Goga D, Guibaud L, Herbreteau D, Le Touze A, Leaute-Labreze C, Lorette G, Mallet S, Martin L, Mazereeuw-Hautier J, Phan A, Plantin P, Quere I, Vabres P, Bourgoin H, Giraudeau B, Maruani A; Groupe de Recherche de la Societe Francaise de Dermatologie Pediatrique. Topical sirolimus 0.1% for treating cutaneous microcystic lymphatic malformations in children and adults (TOPICAL): protocol for a multicenter phase 2, within-person, randomized, double-blind, vehicle-controlled clinical trial. Trials. 2019 Dec 17;20(1):739. doi: 10.1186/s13063-019-3767-8.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via OAI-PMH doi match)

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

sponsor_collaborators:
University Hospital, Tours
University Hospital, Angers

location_facility:
NICE
NECKER
QUIMPER
TOULOUSE
CAEN
ANGERS
Montpellier
Lariboisiere
LYON PED
Marseille
NANTES
NANCY
RENNES
LYON AD
BORDEAUX
TOURS
DIJON

status: Recruiting

title: 0.1% Topical Sirolimus in the Treatment of Cutaneous Microcystic Lymphatic Malformations in Children and Adults: Phase II, Split-body Randomized, Double-blind, Vehicle-controlled Clinical Trial

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Anticipated

design_allocation: Randomized

study_completion_date_type: Anticipated

study_type: Interventional

ipd_sharing: No

lead_sponsor_type: academique

status_simplified: Ongoing

appel_a_projets: PHRCN

region: Centre-Val de Loire

nom_etablissement: CHU DE TOURS

type_etablissement: CHUR

acronyme: TOPICAL

titre: Evaluation de l'efficacité et de la tolérance du sirolimus topique 0,1% dans les malformations cutanées lymphatiques microkystiques : essai thérapeutique de phase II, randomisé, en double aveugle, en comparaison intra-individuelle versus véhicule

discipline_principale: dermatologie

nom_porteur: Maruani

prenom_porteur: Annabel


title: Multimodal Immune Characterization of RAre Soft Tissue Sarcoma - MIRAS Project From SARRA (SARcome RAre) Project of the French Sarcoma Group

acronym: MIRAS

summary:
This trial is a translational, open-label, multi-sites, prospective and retrospective cohort study of 500 patients aimed at clinical and biological characterization of sarcoma of rare subtype.

400 patients will be included in this prospective cohort study; they will be identified in the investigating centers in the context of either routine care or a clinical study protocol.

Retrospective cases of patients (100 cases in total) will be identified in all centers through the GSF/GETO clinical databases already setted up (including the clinical base Conticabase).

primary_purpose: Other

lead_sponsor: Institut Claudius Regaud

location_facility: Institut de Cancérologie Strasbourg Europe

location_facility: Institut de Cancerologie de L'Ouest - Site Rene Gauducheau

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

intervention_type: Other

lead_sponsor_type: industriel


title: Epidemiological, Clinical, Microbiological and Outcome Description of Patients With Klebsiella sp Meningitis

acronym: KlebsieLCR

summary: Klebsiella pneumoniae is implicated in the occurrence of severe pneumonia. Most Klebsiella pneumoniae infections are associated with care and occur in patients with compromised immune defenses. More recently, cases of hepatic abscess and acute community meningitis related to strains of Klebsiella pneumoniae have been reported. The mortality of these infections is important, most often due to a delayed diagnosis. The poor prognostic factors reported in the literature for very low numbers are: advanced age, coma, septic shock, glyceryachia <10mg / dL and proteinuria> 750 mg / dL. In addition, no study has specifically focused on the factors of occurrence and factors associated with Klebsiella sp. Indeed, meningitis related to Klebsiella pneumoniae seems to be a rare but probably underestimated event whose risk factors, clinical presentation, microbiological are little known and the treatment modalities of this severe infection are not codified.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

enrollment_type: Actual

lead_sponsor: Fondation Hôpital Saint-Joseph

location_facility:
CHU Nantes
Hôpital Cochin
CHU Kremlin Bicetre
CHU Strasbourg
Hôpital Foch
CHU Nice
CHU Reims
Hôpital Lariboisière
Hôpital Necker Enfants Malades
CHU Rennes
CHU Tours
CHU Poitiers
CHU Caen
CHU Brest
CHU Lyon
Hôpital henri Mondor
Hôpital Sainte Anne
Groupe Hospitalier Paris Saint-Joseph

status_simplified: Completed


type: Other Identifier

title: A Prospective Study Assessing Whether Immunoscore Colon Test Impacts the Choice of Adjuvant Chemotherapy, in a Multidisciplinary Meeting, for Treating Non-metastatic Colon Cancer Patients After Curative-intent Surgery

acronym: PROSCORE

summary: Immunoscore Colon Test (ICT) will be applied on tumor samples from curative surgery. In the Multidisciplinary Meeting (MM) evaluating the participant adjuvant strategy, a first decision will be taken, based on the participant medical record only. ICT will then be disclosed and the MM will take a second decision. The aim of the study is to observe if the ICT result modifies the treatment decision.

study_start_date_type: Anticipated

status: Withdrawn

primary_purpose: Diagnostic

ReferenceType: background

ReferenceCitation: Pages F, Mlecnik B, Marliot F, Bindea G, Ou FS, Bifulco C, Lugli A, Zlobec I, Rau TT, Berger MD, Nagtegaal ID, Vink-Borger E, Hartmann A, Geppert C, Kolwelter J, Merkel S, Grutzmann R, Van den Eynde M, Jouret-Mourin A, Kartheuser A, Leonard D, Remue C, Wang JY, Bavi P, Roehrl MHA, Ohashi PS, Nguyen LT, Han S, MacGregor HL, Hafezi-Bakhtiari S, Wouters BG, Masucci GV, Andersson EK, Zavadova E, Vocka M, Spacek J, Petruzelka L, Konopasek B, Dundr P, Skalova H, Nemejcova K, Botti G, Tatangelo F, Delrio P, Ciliberto G, Maio M, Laghi L, Grizzi F, Fredriksen T, Buttard B, Angelova M, Vasaturo A, Maby P, Church SE, Angell HK, Lafontaine L, Bruni D, El Sissy C, Haicheur N, Kirilovsky A, Berger A, Lagorce C, Meyers JP, Paustian C, Feng Z, Ballesteros-Merino C, Dijkstra J, van de Water C, van Lent-van Vliet S, Knijn N, Musina AM, Scripcariu DV, Popivanova B, Xu M, Fujita T, Hazama S, Suzuki N, Nagano H, Okuno K, Torigoe T, Sato N, Furuhata T, Takemasa I, Itoh K, Patel PS, Vora HH, Shah B, Patel JB, Rajvik KN, Pandya SJ, Shukla SN, Wang Y, Zhang G, Kawakami Y, Marincola FM, Ascierto PA, Sargent DJ, Fox BA, Galon J. International validation of the consensus Immunoscore for the classification of colon cancer: a prognostic and accuracy study. Lancet. 2018 May 26;391(10135):2128-2139. doi: 10.1016/S0140-6736(18)30789-X. Epub 2018 May 10.

lead_sponsor: UNICANCER

sponsor_collaborators: UNICANCER HalioDx

location_facility: Institut Régional du Cancer de Montpellier

intervention_type: Diagnostic Test

status_simplified: Unknown


acronym: GEMPAX

summary: This study aims to evaluate whether the combination of gemcitabine and paclitaxel allows to improve the overall survival compared to gemcitabine alone, in patients with metastatic Pancreatic Ductal Adenocarcinoma (PDAC) after FOLFIRINOX failure or intolerance.

ReferenceCitation: Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.

location_facility:
CH de Bayeux
Centre Léon Bérard
Institut Mutualiste Montsouris
Centre Eugène Marquis
CHU Jean Minjoz
Hôpital Nord Franche Comté
Hospices civils de Lyon
Institut Curie
Hôpital Saint-Louis
CHU La Timone
CH Simone Veil
Hôpital Trousseau
CHU Rouen
Institut de Cancérologie de l'Ouest
Institut Gustave Roussy
Centre Georges François Leclerc
CH du Cotentin
CHU de Saint-Etienne
Centre Antoine Lacassagne
Hôpital Saint-Joseph
Institut Paoli Calmettes
Hôpital Pitié-Salpétrière
Hôpital Européen de Marseille
Institut Godinot
Hôpital Duchenne
Hôpital Broussais

title: A Phase III Randomized Study Evaluating Gemcitabine and Paclitaxel Versus Gemcitabine Alone After FOLFIRINOX Failure or Intolerance in Metastatic Pancreatic Ductal Adenocarcinoma

appel_a_projets: PHRCK

region: Île-de-France

nom_etablissement: GCS UNICANCER SIEGE

type_etablissement: GCS

acronyme: GEMPAX

titre: GEMPAX : essai de phase III randomisé évaluant l'association gemcitabine +paclitaxel vs gemcitabine seule en 2ème ligne de traitement après échec de FOLFIRINOX.

discipline_principale: cancer

nom_porteur: DE LA FOUCHARDIERE

prenom_porteur: Christelle


acronym: PROGRESSION

lead_sponsor: Hospices Civils de Lyon

summary:
Idiopathic pulmonary fibrosis (IPF) is a prototype of chronic, progressive, and fibrotic lung disease. It has been considered rare, with an incidence estimated to 11.5 cases per 100 000 individuals per year. Increasing rates of hospital admissions and deaths due to IPF suggest an increasing burden of disease. The median survival time from diagnosis is 2-4 years.

Recently two disease-modifying therapies, pirfenidone and nintedanib, have been approved worldwide. Both drugs reduce the disease progression as measured by progressive decline in forced vital capacity (FVC), with a reduction of overall mortality showed by meta-analysis of phase III pirfenidone trials.

However, progression of disease continues to occur despite the currently available drug therapy. Many patients die from progressive, chronic hypoxemic respiratory failure, or less frequently from acute exacerbation of pulmonary fibrosis. In these patients, no data are available to guide management between continuation of the prescribed antifibrotic drug, to switch to the other available antifibrotic drug, or to combine the available drugs.

The combination of nintedanib and pirfenidone is not recommended outside clinical trials. However, although both antifibrotic drugs were developed and approved as monotherapy, two recent trials have suggested the feasibility and safety of combining them over a 12-24 weeks period. These results encourage further studies of combination treatment with pirfenidone and nintedanib in patients with IPF. Such study is timely, as there is a risk that clinicians facing the continued worsening of disease in patients receiving one of the available drugs may prescribe both drugs combined outside clinical trials, potentially exposing patients to a currently unknown risk.

This study will evaluate the efficacy and tolerance of the combination pirfenidone and nintedanib as compared to a "switch monotherapy": i.e. switching from the current to the other of the two existing drugs prescribed as monotherapy, in patients who present chronic worsening IPF despite receiving either pirfenidone or nintedanib and as to a "control group": i.e.treatment still be on as before randomization (pirfenidone or nintedanib).

location_facility: Hôpital Pneumologique et Cardiovasculaire Louis Pradel

location_facility: CHU Dijon Bourgogne - Hôpital François Mitterrand

location_facility: APHP - Hôpital Xavier Bichat-Claude Bernard

location_facility: CHU de Caen - Hôpital de la Côte de Nacre

location_facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve

title: Pragmatic Management of Progressive Disease in Idiopathic Pulmonary Fibrosis: a Randomized Trial

ipd_sharing: Undecided

region: Auvergne-Rhône-Alpes

nom_etablissement: HOSPICES CIVILS DE LYON

acronyme: PROGRESSION-IPF

titre: Prise en charge pragmatique de la fibrose pulmonaire idiopathique en progression. Etude PROGRESSION-IPF

discipline_principale: pneumology

nom_porteur: COTTIN

prenom_porteur: Vincent


title: BLINAtumomab After R-CHOP Debulking Therapy for Patients With Richter Transformation

summary:
Blinatumomab (BLINCYTO) is a bi-specific T-cell engaging (BiTE®) antibody construct that transiently links CD3-positive T cells to CD19-positive B-cells, inducing T-cell activation and subsequent lysis of tumor cells.

The investigators propose to evaluate the efficacy, safety and tolerability of blinatumomab administered after R-CHOP debulking therapy in patients with Richter Syndrome (RS) of diffuse large B-cell lymphoma (DLBCL) histology.

The investigators hypothesize that 8-week blinatumomab induction therapy leads to Complete Response (CR) rate improvement (revised Cheson criteria) from a baseline of 7percent as observed in the prospective study evaluating R-CHOP.

lead_sponsor: French Innovative Leukemia Organisation

sponsor_collaborators:
French Innovative Leukemia Organisation
Amgen

location_facility: Institut Paoli-Calmettes - Hématologie Clinique

location_facility: CHU Pontchaillou - Hématologie Clinique BMT-HC

location_facility: Hôpital Robert Debré - Hématologie Clinique

location_facility: CHU Estaing - Hématologie Clinique Adulte

location_facility: Hôpital Bretonneau - Hématologie et Thérapie Cellulaire

location_facility: Hôpitaux de Brabois - Hématologie Adulte

location_facility: Hôpital Avicenne - Centre de Recherche Clinique

location_facility: Hopital Pitie Salpetriere Service Hematologie Clinique - Pavillon de L'Enfant Et Adolescent

location_facility: Hôpital de la Milétrie - Hématologie et Thérapie Cellulaire

location_facility: Centre Henri Becquerel - Service Hématologie Clinique

location_facility: CENTRE HOSPITALIER SAINTJEAN - Hématologie Clinique


title: OPEN LABEL PHASE 2 STUDY ON THE EFFICACY AND TOLERANCE OF A COMBINATION OF PONATINIB AND 5-AZACITIDINE IN CHRONIC MYELOGENOUS LEUKAEMIA IN ACCELERATED PHASE OR IN MYELOID BLAST CRISIS - PONAZA TRIAL

acronym: PONAZA

summary:
This project is strategy aiming to improve the survival of patients with chronic myelogenous leukemia in advanced phase and myeloid blast crisis.

The basis of this strategy is to add the demethylating agent 5-Azacitidine to the tyrosine kinase inhibitor ponatinib and evaluate its activity in 2 cohorts of patients with either chronic myelogenous leukemia in advanced phase or myeloid blast crisis.

design_allocation: Non-Randomized

lead_sponsor: Versailles Hospital

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier Universitaire de Limoges

location_facility: Institut Universitaire Du Cancer Toulouse

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: Centre Hospitalier Universitaire de Clermont Ferrand

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Centre Hospitalier Universitaire D'Amiens

location_facility: Centre Hospitalier Universitaire de Dijon


type: Registry Identifier

title: PALbociclib in Advanced Breast Cancer: Therapy INtegrating locorEgional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients

acronym: PALATINE

summary:
Approximately 3.5% to 6% of newly diagnosed breast cancer patients are stage IV metastatic. De novo metastatic breast cancer accounts for 20% to 25% of these cases. Despite a decrease in mortality in Europe and North America due to early detection and access to treatment, breast cancer remains the 2ⁿᵈ leading cause of cancer deaths in developed countries after lung cancer and the world's leading cause.

In the ESME French national retrospective cohort (NCT03275311), the newly diagnosed estrogen receptor (ER)-positive and HER2-negative (luminal) metastatic patients had a 59.1 months overall survival (OS) for pre-menopausal women and 44.7 months for postmenopausal women. In the same cohort, the median OS was 47.4 months for de novo metastatic patients with hormone receptor (HR)-positive / HER2-negative breast cancer.

The most important current treatment for metastatic breast cancer remains systemic therapy. Surgery and radiation are mainly used to treat symptoms. However, more than 15 retrospective studies have assessed the impact of locoregional treatment on relapse and OS. These studies suggested an improvement of the OS in patients with de novo metastatic breast cancer thanks to the addition of locoregional treatment to systemic therapy. Recent data from the ESME cohort suggest that patients with de novo luminal or HER2-positive metastatic breast cancer may benefit from local treatment of the primary tumor.

Several prospective trials have attempted to demonstrate the benefit of locoregional treatment with mixed results. This can be explained by a limited power of statistical analysis, on the recruitment of patients with breast cancer of all types, and on a limited access to effective systemic therapies in some cases and all before the area of anti CD4/6 which is the current standard treatment in patients with HR-positive / HER2-negative luminal metastatic disease.

However, guidelines indicate that a "multimodal approach, including curative locoregional treatments, should be considered". As a result, many clinicians offer locoregional treatment of the primary tumor, especially if there is a good response to the first line of systematic treatment.

Taken together, these data underscore the need for an evaluation of the value of combined therapy - endocrine therapy - CDK4/6 inhibitor and locoregional treatment - in this population of patients with newly diagnosed HR-positive / HER2-negative breast cancer.

status: Active, not recruiting

ipd_sharing: Yes

ipd_sharing_description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

sponsor_collaborators: UNICANCER Pfizer

location_facility: Institut de Cancérologie de l'Ouest-Site Paul Papin

location_facility: GCS RISSA - Institut de cancérologie Paris Nord


title: Phase II Trial of Trastuzumab in Combination With Pertuzumab in Pretreated Patients With Non-small Cell Lung Cancer (NSCLC) Harboring a Her2 Mutation and Receiving Docetaxel

summary: HER2 (erbB-2/neu) is a member of the erbB receptor tyrosine kinase family. ERBB2 gene which encodes human epidermal growth factor 2 (HER2) is a major proliferative driver activating downstream signaling through PI3K-AKT and MEK-ERK. HER2 overexpression or gene amplification is associated with sensitivity to trastuzumab and lapatinib in breast cancer. Among actual lung cancer biomarker, HER2 remains apart. HER2 involvement is known for a long time but clinical research has been stopped for many years since the first clinical trials in unselected patients were negative. Recently trastuzumab + pertuzumab + docetaxel has been tested for first-line treatment of HER2-positive metastatic breast cancer (CLEOPATRA trial). Analysis of the primary end point showed that patients who received pertuzumab, trastuzumab, and docetaxel (pertuzumab group) had a significantly longer median progression-free survival, as assessed by independent reviewers an did those who received placebo, trastuzumab, and docetaxel (control group) (hazard ratio favoring the pertuzumab group, 0.62). There is thus a strong rational for treating HER2 mutated lung cancer patient with these drugs.

ReferenceType: result

ReferenceCitation: Mazieres J, Lafitte C, Ricordel C, Greillier L, Negre E, Zalcman G, Domblides C, Madelaine J, Bennouna J, Mascaux C, Moro-Sibilot D, Pinquie F, Cortot AB, Otto J, Cadranel J, Langlais A, Morin F, Westeel V, Besse B. Combination of Trastuzumab, Pertuzumab, and Docetaxel in Patients With Advanced Non-Small-Cell Lung Cancer Harboring HER2 Mutations: Results From the IFCT-1703 R2D2 Trial. J Clin Oncol. 2022 Mar 1;40(7):719-728. doi: 10.1200/JCO.21.01455. Epub 2022 Jan 24.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

location_facility:
Caen - CHU Côte de Nacre
CHI Créteil
CHU Toulouse
Lyon - URCOT
Centre Hospitalier - Pneumologie
Rennes - CHU
AP-HP Hôpital Bichat
Gustave Roussy
CHU Besançon
Clermont-Ferrand - CHU
Nice CLCC
Hôpital Nord APHM
Montpellier - CHRU
AP-HP Hopital Tenon - Pneumologie
CHU Strasbourg
CHU de Nantes
CHRU Grenoble
CHU de Bordeaux


title: A Multicenter, Randomised, Open-label Phase II Study to Evaluate the Clinical Benefit of a Post-operative Treatment Associating Radiotherapy + Nivolumab + Ipilimumab Versus Radiotherapy + Capecitabine for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy

summary: To evaluate the clinical benefit of a post-operative adjuvant therapy combining radiotherapy + Nivolumab + Ipilimumab versus radiotherapy + Capecitabine in Triple Negative Breast Cancer (TNBC) patients with residual disease after neoadjuvant chemotherapy.

lead_sponsor: Centre Leon Berard

location_facility:
Hopital Prive Jean Mermoz
Centre Paul Strauss
Centre Léon Bérard
Centre d'Oncologie Radiothérapie 37
Centre Antoine Lacassagne
Clinique de la Sauvegarde
Institut Curie
Institut de Cancérologie de l'Ouest
GH Pitié-Salpêtrière-Charles Foix
CHRU Besançon
Hôpital Drôme Ardèche
Institut Sainte Catherine
Institut Jean Godinot
Institut Paoli Calmettes
Centre Francois Baclesse


title: A Randomized Non-comparative Phase II Study of Maintenance Therapy With OSE2101 Plus FOLFIRI, or FOLFIRI After Induction Therapy With FOLFIRINOX in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (TEDOPaM-D17-01 PRODIGE 63 Study)

acronym: TEDOPAM

summary: TEDOPAM is a randomized (1.1.1) non-comparative phase II study. This study will assess the efficacy and safety of OSE2101 alone or in combination with nivolumab followed by FOLFIRI reintroduction, versus FOLFIRI as maintenance therapy in patients with advanced PDAC after induction therapy with FOLFIRINOX.

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Hôpital Lyon Sud Hospices Civils de Lyon


title: Personalized Medicine for Membranous Nephropathy

acronym: PMMN

summary:
Randomized, open label, multicentre (20 sites), prospective trial comparing the efficacy of two therapeutic strategies to obtain clinical remission 1 year after diagnosis of Idiopathic Membranous Nephropathy with nephrotic syndrome and anti-PLA2R1 (phospholipase A2 receptor 1) antibodies:

GEMRITUX protocol: 6 months of symptomatic antihypertensive and antiproteinuric therapy, and if the nephrotic syndrome persists at month-6 (urinary protein/creatinine ratio (UPCR) remains > 3.5 g/g and albuminemia < 30 g/l), two 375 mg/m2 rituximab infusions at 1-week interval.

Personalized treatment:

restricted anti-CysR activity at inclusion : 6-month symptomatic antihypertensive and antiproteinuric treatment (KDIGO)
restricted anti-CysR activity after 6 months of symptomatic treatment with persisting nephrotic syndrome (UPCR remains > 3.5 g/g and albuminemia < 30 g/l): two 375 mg/m2 rituximab infusions at 1-week interval;
Anti-CTLD (C-type lectin domains ) 1/7 activity at inclusion or after 6 months with persisting nephrotic syndrome (UPCR remains > 3.5 g/g and albuminemia < 30 g/l): two 1g rituximab infusions at 2-week interval at month 0 and/or month 6.

status: Unknown status

ReferenceCitation: Simon N, Courouce AM, Lemarrec N, Trepo C, Ducamp S. A twelve year natural history of hepatitis C virus infection in hemodialyzed patients. Kidney Int. 1994 Aug;46(2):504-11. doi: 10.1038/ki.1994.301.

ReferenceCitation: Simon P, Ramee MP, Boulahrouz R, Stanescu C, Charasse C, Ang KS, Leonetti F, Cam G, Laruelle E, Autuly V, Rioux N. Epidemiologic data of primary glomerular diseases in western France. Kidney Int. 2004 Sep;66(3):905-8. doi: 10.1111/j.1523-1755.2004.00834.x.

ReferenceCitation: Ponticelli C. Membranous nephropathy. J Nephrol. 2007 May-Jun;20(3):268-87.

ReferenceCitation: Glassock RJ. The pathogenesis of idiopathic membranous nephropathy: a 50-year odyssey. Am J Kidney Dis. 2010 Jul;56(1):157-67. doi: 10.1053/j.ajkd.2010.01.008. Epub 2010 Apr 8.

ReferenceCitation: Lassalle M, Ayav C, Frimat L, Jacquelinet C, Couchoud C; Au Nom du Registre REIN. The essential of 2012 results from the French Renal Epidemiology and Information Network (REIN) ESRD registry. Nephrol Ther. 2015 Apr;11(2):78-87. doi: 10.1016/j.nephro.2014.08.002. Epub 2014 Nov 1.

publisher_dissemination: John Libbey Eurotext

ReferenceCitation: Brglez V, Boyer-Suavet S, Zorzi K, Fernandez C, Fontas E, Esnault V, Seitz-Polski B. Personalized Medicine for PLA2R1-Related Membranous Nephropathy: A Multicenter Randomized Control Trial. Front Med (Lausanne). 2020 Aug 13;7:412. doi: 10.3389/fmed.2020.00412. eCollection 2020.

repositories_concat: PubMed Central

publisher_dissemination: Frontiers

lead_sponsor: Centre Hospitalier Universitaire de Nice

location_facility:
Le Kremlin Bicêtre
CHU de LYON NORD
CHU D'amiens Hôpital Sud
Hôpital Necker
Hôpital de la maison blanche
CHU de Toulouse
CHU de Strasbourg
CHU Carémeau
CHU Henri Mondor
CHRU de LILLE
Dr Barbara SEITZ-POLSKI
CHU de NANTES
CHU Gabriel Montpied
CHU de Tours
AP-HM
Hôpital universitaire La Cavale Blanche
CHU de Caen
CHU Besançon
CHRU de Montpellier

region: Provence-Alpes-Côte d'Azur

nom_etablissement: CTRE HOSPITALIER UNIVERSITAIRE DE NICE

acronyme: PMMN

titre: Médecine personnalisée pour le traitement de la glomérulonéphrite extramembraneuse

discipline_principale: néphrologie

nom_porteur: Seitz-Polski

prenom_porteur: Barbara


title: Study of Survival and Description of Care for Patients With Degenerate Vaterian Ampulloma

acronym: AMPULLOMA

summary: A Vater's ampulloma is a rare digestive tumour which accounts for under 1% of all digestive tumours. The only curative treatment is complete excision (surgical or endoscopic) of the lesions which is possible in 80% of cases , with or without adjuvant treatment. The reference radical treatment is cephalic duodenopancreatectomy (CDP). The indication for adjuvant treatment is still debated: in view of the aggressive nature of the disease and the high recurrence rate, it would appear appropriate to offer adjuvant treatment, although several studies have failed to find any benefit on survival with post-operative radio-chemotherapy, the most widely studied treatment at present, compared to excision alone. At present there are no phase II studies specifically examining medical treatment of degenerated, inoperable Vater's ampullomas. Some groups propose chemotherapies with 5-FU or gemcitabine, analogous to the treatments used for intestinal, pancreatic or biliary tumours, although neither one has been shown to date to be superior to the other, nor have decision-making criteria been clearly established.In conclusion, a national cohort study is proposed to undertake a prospective analysis of the outcome of all patients treated for ampullary adenocarcinoma (particularly survival without recurrence and prognostic indicators for excised tumours and the duration of disease control for tumours treated with palliative chemotherapy). The treatment methods will be left to the free choice of the investigator and all patients may be included, regardless of stage of their disease. In this study, freezing of tumour fragments is encouraged, as this cohort will be supplemented by a later biological study. In order to recruit sufficient patient numbers, the study will be based on participation of the cooperative groups involved in the management of digestive cancers.

time_perspective: Prospective

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility:
Hopital Saint Joseph
Chu Caremeau
Chu Claude Huriez
Ch Nord Essonne
CH MACON
Ch Annecy Genevois
Ch Bretagne Atlantique
Chu Hotel Dieu
Chu Francois Mitterrand
Ch Saint Jean
Chu Avicenne
Chd Vendee
CLINIQUE
Ch Saint Malo
Chr Orleans
Hopitaux Civils de Colmar
CHU Hôpital de la Milétrie
CH
Chu Saint Andre
Chu La Pitie Salpetriere
Ch - Sud Francilien
Ch Cote Basque
Hopital de La Timone
Ch D'Abbeville
Hcl Pierre Benite
Chu Estaing
Chu La Croix Rousse
Ch de Meaux
Hopital Europeen Georges Pompidou
Hcl Edouard Herriot
Hôpital Dupuytren
Ch Cornouaille
Clinique Champeau
Le Kremlin Bicetre
Chu Cochin
Polyclinique Bordeaux Nord Aquitaine


title: Efficacy of Regorafenib as Maintenance Therapy in Non-adipocytic Soft Tissue Sarcoma Having Received First-line Doxorubicin-based Chemotherapy

summary: Multicenter double-blind placebo-controlled randomized Phase II study comparing regorafenib® to placebo, as maintenance therapy in metastatic soft-tissue non-adipocytic sarcomas experiencing stable disease or response after 6 cycles of doxorubicin-based chemotherapy as 1st line chemotherapy.

status: Suspended

lead_sponsor: Centre Oscar Lambret

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: Institut régional du Cancer de Montpellier


title: Predictive Value of Progastrin Titer at Diagnosis and of Progastrin Kinetics During Treatment in Cancer Patients

acronym: ONCOPRO

summary:
Progastrin is a pro-hormone that, in physiological conditions, is maturated in gastrin in G cells of the stomach. The role of the gastrin is to stimulate the secretion of gastric acids during digestion. It is also important for the regulation of cell growth of the gastric mucosal.

In a healthy person, progastrin is not detectable in the peripheral blood. However, progastrin is abnormally released in the blood of patients with different cancers (colorectal, gastric, ovarian, breast, cervix uterus, melanoma…) The gene GAST coding for progastrin is a direct target gene of the WNT/ß-catenin oncogenic pathway. The activation of this oncogenic pathway is an early event in cancer development.

Chronic activation of the WNT/ß-catenin oncogenic pathway occurs in almost all human solid tumors and is a central mechanism in cancer biology that induces cellular proliferation, blocking of differentiation leading to primary tumor growth and metastasis formation.

Progastrin measured in the peripheral blood of patients on treatments, could be a new powerful marker for diagnosis and prognosis at different stages.

location_facility: Service de Gynécologie de l'hôpital Lyon Sud

location_facility: Service de Dermatologie de l'hôpital Lyon Sud

location_facility: Service de Gynécologie de l'hôpital de la Croix-Rousse

location_facility: Service d'Hématologie de l'Hôpital Lyon Sud

location_facility: Service d'ONCOLOGIE DIGESTIVE et HEPATOLOGIE de l'Hôpital E. Herriot

location_facility: Service de Pneumologie de l'Hôpital Lyon Sud

location_facility: Service de Pneumologie de l'hôpital de la Croix-Rousse

location_facility: Service de Gynécologie du Groupement Hospitalier Est

location_facility: Service de NEURO-ONCOLOGIE du Groupement Hospitalier EST

location_facility: Service d'Urologie de l'Hôpital E. Herriot

location_facility: Service d'ONCOLOGIE DIGESTIVE et HEPATOLOGIE du Centre Hospitalier Lyon Sud

location_facility: Service de Pneumologie du Groupement Hospitalier Est

location_facility: Service d'Oto-Rhino-Laryngologie de l'Hôpital de la Croix-Rousse

location_facility: Service d'Oncologie médicale du Centre hospitalier Lyon Sud

location_facility: Service d'Urologie de l'hôpital Lyon Sud

location_facility: Service de Chirurgie de l'hôpital Lyon Sud

location_facility: Service d'ONCOLOGIE DIGESTIVE et HEPATOLOGIE de l'hôpital de la Croix-Rousse


title: Preemptive Therapy With Venetoclax for High Risk Chronic Lymphoid Leukemia Stage A Patients, a Phase II Trial of the FILO

summary: Open label, single arm, multicenter phase II trial.

ipd_sharing_description: eCRF

location_facility: Hôpital Bretonneau - Hématologie et Thérapie Cellulaire

location_facility: Centre Hospitalier Regional Metz Thionville

location_facility: Centre Henri Becquerel - Service Hématologie Clinique


title: Second-Line Chemotherapy With Ramucirumab +/- Paclitaxel in Elderly Advanced Gastric or Gastroesophageal Junction Cancer Patients

acronym: SOCRATE

summary:
The primary objective is to evaluate six months survival rate and quality of life at 4 months of ramucirumab alone or in combination with paclitaxel in patients aged 70 years or more who have stomach or GEJ adenocarcinoma and whose first line of fluoropyrimidine- and platinumcontaining treatment has failed.

The co-primary endpoints are the following:

Six months survival rate
Quality of life at 4 months as assessed by the following three target dimensions of the EORTC QLQ-ELD14 questionnaire: mobility, illness burden and worries about the future

sponsor_collaborators: Federation Francophone de Cancerologie Digestive

location_facility: Privee - Institut Du Cancer Avignon Provence


title: A New Breath for Malignant Hypertension: Implementation of the HAMA Cohort

acronym: HAMA

summary: This registry aims to provide the first prospective, multicentric database of patients with malignant hypertension. It will allow to assess modern epidemiology of the disease, diversity of current management and care pathway, to deepen our pathophysiological knowledges, to modernize the definition of this form of hypertension and its diagnostic criteria. The network that will emerge will finally lead to the opportunity of setting up therapeutic trials and establishing recommendations based on solid scientific evidence.

lead_sponsor: Centre Hospitalier de PAU

location_facility:
Hôpital Européen Georges Pompidou
CHU de Montellier
CHU de Poitiers
CH de St Nazaire
CHU de St Etienne
Hôpital Saint Joseph
CHU de Rennes
CH d'Annecy
CH Métropole
Hôpital Tenon
CH de PAU
CH de Dinard
CHU de Strasbourg
CHRU de Lille
Clinique sainte Clotilde
CH de Chalon sur Saone
CH de la côte Basque
CH de Valenciennes
CHU de Tours
hôpital de Haguenau
Pôle Santé Sud
Fondation Adolphe de Rothschild
Clinique Vert Coteau
Hôpital Henri Mondor
CHU Michallon
CH de Libourne
Avicenne APHP
CHU de Clermont FERRAND
Hopital de la conception
CHU de ROUEN
CH Martigues
APHP Bichat
CHU - Hôpital Laennec
CHU de Pointe à Pitre
CHU - Hôpital St André
CHU de Toulouse Rangueil


title: Multicenter Double Blind Randomized Phase II Trial of Olaparib vs Placebo as Maintenance Therapy in Platinum-sensitive Advanced Endometrial Carcinoma

acronym: UTOLA

summary: This is a phase IIB, national, randomized, double-blinded, comparative, multi-center study, to assess the efficacy of Olaparib as maintenance after a platinum based chemotherapy in patients with Advanced or metastatic endometrial cancer

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Institut de Cancérologie de Lorraine - Centre Alexis Vautrin

location_facility: CHU de Poitiers - Hôpital de la Milétrie

location_facility: Institut de Cancérologie du Gard - CHU de Nîmes

location_facility: Institut inter-régionaL de Cancérologie - Centre Jean Bernard - Clinique Victor Hugo

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Groupe Hospitalier Diaconesses Croix Saint-Simon

location_facility: Institut Daniel Hollard - GHM de Grenoble

location_facility: Institut Curie - Hopital Claudius Régaud

location_facility: CHU Saint Etienne - Pôle de Cancérologie


title: A Single-arm Phase II Multicenter Study of IDH2 (AG-221) Inhibitor in Patients With IDH2 Mutated Myelodysplastic Syndrome

summary: patients with MDS (Myelodysplastic Syndrome) and mutated IDH2 patients will be treated with AG221 (IDH2 inhibitor)

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: Institut Paoli Calmettes/Unité d'Hématologie 3

location_facility: CHU Nantes - Hôtel Dieu/Service d'Hématologie Clinique

location_facility: Institut de cancérologie Lucien Neuwirth Saint priest en Jarez

location_facility: CH d'Angers/Service des Maladies du sang

location_facility: CH Le Mans/Service d'hématologie Oncologie

location_facility: Centre Henri Becquerel/Département d'Hématologie

location_facility: Hôpital Saint Louis - Service d'hématologie séniors

location_facility: CHU Côte de Nacre/Service d'Hématologie Clinique

location_facility: Hôpital Archet 1/Service d'Hématologie Clinique


title: National Observational Study of the Thoraflex™ Hybrid Vascular Prosthesis in the Replacement of the Aortic Arch and the Treatment of Aneurysm/Dissection of the Descending Thoracic Aorta

summary: The purpose of this national observational study is to evaluate the Thoraflex™ Hybrid vascular prosthesis in the replacement of the aortic arch and the treatment of aneurysm/dissection of the descending thoracic aorta in relation to morbidity-mortality, visceral malperfusions, neurological and renal complications, endoleak and evolution of the aortic thoracic stent over time.

ReferenceCitation: Arko FR, Lee WA, Hill BB, Olcott C 4th, Harris EJ, Dalman RL, Fogarty TJ, Zarins CK. Impact of endovascular repair on open aortic aneurysm surgical training. J Vasc Surg. 2001 Nov;34(5):885-91. doi: 10.1067/mva.2001.118816.

ReferenceCitation: Karck M, Chavan A, Hagl C, Friedrich H, Galanski M, Haverich A. The frozen elephant trunk technique: a new treatment for thoracic aortic aneurysms. J Thorac Cardiovasc Surg. 2003 Jun;125(6):1550-3. doi: 10.1016/s0022-5223(03)00045-x. No abstract available.

ReferenceCitation: Usui A, Ueda Y, Watanabe T, Kawaguchi O, Ohara Y, Takagi Y, Tajima K, Nishikimi N, Ishiguchi T. Clinical results of implantation of an endovascular covered stent-graft via midsternotomy for distal aortic arch aneurysm. Cardiovasc Surg. 2000 Dec;8(7):545-9. doi: 10.1016/s0967-2109(00)00066-1.

ReferenceCitation: Karck M, Kamiya H. Progress of the treatment for extended aortic aneurysms; is the frozen elephant trunk technique the next standard in the treatment of complex aortic disease including the arch? Eur J Cardiothorac Surg. 2008 Jun;33(6):1007-13. doi: 10.1016/j.ejcts.2008.02.030. Epub 2008 Apr 10.

ReferenceCitation: Shrestha M, Pichlmaier M, Martens A, Hagl C, Khaladj N, Haverich A. Total aortic arch replacement with a novel four-branched frozen elephant trunk graft: first-in-man results. Eur J Cardiothorac Surg. 2013 Feb;43(2):406-10. doi: 10.1093/ejcts/ezs296. Epub 2012 May 31.

ReferenceCitation: Patel AY, Eagle KA, Vaishnava P. Acute type B aortic dissection: insights from the International Registry of Acute Aortic Dissection. Ann Cardiothorac Surg. 2014 Jul;3(4):368-74. doi: 10.3978/j.issn.2225-319X.2014.07.06.

ReferenceCitation: Tsai TT, Trimarchi S, Nienaber CA. Acute aortic dissection: perspectives from the International Registry of Acute Aortic Dissection (IRAD). Eur J Vasc Endovasc Surg. 2009 Feb;37(2):149-59. doi: 10.1016/j.ejvs.2008.11.032. Epub 2008 Dec 20.

ReferenceCitation: Jakob H, Tsagakis K. International E-vita open registry. Ann Cardiothorac Surg. 2013 May;2(3):296-9. doi: 10.3978/j.issn.2225-319X.2013.03.10.

ReferenceCitation: Bortone AS, Schena S, D'Agostino D, Dialetto G, Paradiso V, Mannatrizio G, Fiore T, Cotrufo M, de Luca Tupputi Schinosa L. Immediate versus delayed endovascular treatment of post-traumatic aortic pseudoaneurysms and type B dissections: retrospective analysis and premises to the upcoming European trial. Circulation. 2002 Sep 24;106(12 Suppl 1):I234-40.

lead_sponsor: Vascutek Ltd.

location_facility: Hôpital Rangueil, Cardiothoracic Surgery Department

location_facility: Groupe Hospitalier Pitié-Salpêtrière, Vascular Surgery Department

location_facility: Centre Hospitalier University (University Hospital centre)

location_facility: Hopitaux Universitaires - Nouvel Hopital Civil

intervention_type: Device


title: A Phase II Pilot Study to Evaluate the Safety and Efficacy of the Association of Ibrutinib and Daratumumab in Relapsed/Refractory Chronic Lymphocytic Leukemia With p53 Dysfunction. IDA53 Trial

summary:
Ibrutinib, a first-in-class Bruton Tyrosine kinase (BTK) inhibitor, has become an established treatment in relapsed/refractory chronic lymphocytic leukemia (CLL). However, despite a considerable improvement of Progression Free Survival (PFS) and Overall Survival (OS) in comparison with historical controls, the prognosis of patients with 17p deletion (del17p) remains a concern, as it is clearly much less favourable than that of patient without del17p. Again, TP53 mutations correlated to poorer prognostic in Relapsed/Refractory (R/R) CLL patients treated with ibrutinib (Brown JR et al,2018). Despite these therapeutic advances, the treatment of CLL with TP53 disruption thus remains a difficult issue that warrants evaluation of alternative treatment strategies, in particular the use of ibrutinib in combination with other agents. A body of evidence suggests that targeting the extracellular molecule CD38 might be an interesting option. CD38 is a transmembrane glycoprotein with multiple receptor and enzymatic functions. The interaction of CD38 with its ligand CD31 (also known as Platelet Endothelial Cell Adhesion Molecule (PECAM-1)) not only plays a role in the binding and the migration of leucocytes through the endothelial cells wall but also triggers the activation of intracellular pathways involved in the differentiation and activation of B cells. Previous results strongly suggest that CD38 favours the expansion of CLL clones not only directly by transducing a proliferation signal but also by directing them to anatomic sites where they find favourable conditions for proliferation and survival.

Daratumumab is a first-in-class human IgG1ĸ monoclonal antibody (mAb) that binds CD38-expressing malignant cells with high affinity. Daratumumab induces tumor cell death through multiple mechanisms such as antibody-dependent cell-mediated cytotoxicity (ADCC), complement dependent cytotoxicity (CDC), antibody-dependent cellular phagocytosis (ADCP) and induction of apoptosis (de Weers et al, 2011). Recent data show that daratumumab may also display an immunomodulatory effect through depletion of a subset of immunosuppressive CD38+ Tregs (Krejcik et al, 2016). Early-stage clinical trials found daratumumab to be safe and to display encouraging clinical activity as a single agent in relapsed/refractory multiple myeloma (MM) patients (Lockhorst et al 2016, Lonial et al, 2016). Overall response rate was 31%, with rapid (median 1 month) and durable responses in this heavily pretreated MM population. Interestingly, no patient discontinued the treatment because of drug-related adverse events. These results led to approval of daratumumab in relapsed/refractory MM in December 2015. The clinical efficacy of daratumumab along with its very favourable safety profile supports its investigation in other lymphoproliferative malignancies. In particular, the expression of CD38 in poor prognosis CLL and the key role of CD38 in CLL biology provide a basis for examining the potential of daratumumab in this disease.

In preclinical studies, (Matas-Céspedes et al, 2016; Manna et al, 2017) Daratumumab efficiently kills CLL cell lines and patient-derived CLL cells by ADCC and ADCP in vitro. Daratumumab modulates CLL-T reg levels and increase cytotoxic effector T cells.

Rationale for combining ibrutinib with daratumumab:

These data suggest that combining ibrutinib with daratumumab might have a synergistic or additive effect. Both drugs inhibit B cell receptor (BCR) signalling via two different converging pathways, i.e. BTK and CD38/ZAP70/ERK (Deaglio et al, 2007). In vitro, Manna et al have shown that daratumumab is able to modulate BCR signaling.

Interestingly, the ibrutinib /daratumumab combination significantly enhanced mitochondrial-mediated apoptosis bth in CD38 high and CD38 low CLL cells (Manna et al, 2017).

Altogether, this provides a rationale for evaluating the safety and efficacy of the association of daratumumab with ibrutinib in high-risk relapsed/refractory patients for whom the standard-of-care using ibrutinib as a single agent has demonstrated limitations in terms of long-term disease control.

Primary objective of the study: to determine the efficacy of a treatment combining daratumumab and ibrutinib in a poor risk population of relapsed CLL patients with TP53 dysfunction.

Secondary objectives of the study : to determine the safety profile of daratumumab in combination with ibrutinib in CLL patients.

Inclusion period: 24 months Treatment duration (ibrutinib + daratumumab): continuous, until disease progression or unacceptable toxicity.

Follow-up period: will begin once the subject discontinues study treatment, during 2 years.

sponsor_collaborators:
French Innovative Leukemia Organisation
Janssen, LP

location_facility: Institut Paoli-Calmettes - Hématologie Clinique

location_facility: CHU Pontchaillou - Hématologie Clinique BMT-HC

location_facility: Hôpital Robert Debré - Hématologie Clinique

location_facility: CHU Estaing - Hématologie Clinique Adulte

location_facility: Hôpital Bretonneau - Hématologie et Thérapie Cellulaire

location_facility: CHLS - Lyon Pierre Bénite - Service Hématologie

location_facility: Hôpital Saint-Eloi - Hématologie Clinique

location_facility: Hôpitaux de Brabois - Hématologie Adulte

location_facility: Hôpital Avicenne - Centre de Recherche Clinique

location_facility: Hôpital de la Milétrie - Hématologie et Thérapie Cellulaire

location_facility: Centre Henri Becquerel - Service Hématologie Clinique

location_facility: CHU Bordeaux - Hôpital Haut-Lévèque - CFM Maladies du sang


title: Efficacy of Treatment Sequences in Patients With ALK and ROS-1 Positive Non-small Cell Lung Cancer Who Received Lorlatinib as Part of the French Expanded Access Program

acronym: LORLATU

summary: The study will evaluate progression-free survival, overall survival, best response and duration of treatment in patients with advanced ALK- and ROS1-positive non-small cell lung cancer who received lorlatinib as part of the French expanded access program.

ReferenceCitation: Girard N, Galland-Girodet S, Avrillon V, Besse B, Duruisseaux M, Cadranel J, Otto J, Prevost A, Roch B, Bennouna J, Bouledrak K, Coudurier M, Egenod T, Lamy R, Ricordel C, Moro-Sibilot D, Odier L, Tillon-Strozyk J, Zalcman G, Missy P, Westeel V, Baldacci S. Lorlatinib for advanced ROS1+ non-small-cell lung cancer: results of the IFCT-1803 LORLATU study. ESMO Open. 2022 Apr;7(2):100418. doi: 10.1016/j.esmoop.2022.100418. Epub 2022 Feb 26.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

publisher_dissemination: Elsevier

ReferenceCitation: Baldacci S, Besse B, Avrillon V, Mennecier B, Mazieres J, Dubray-Longeras P, Cortot AB, Descourt R, Doubre H, Quantin X, Duruisseaux M, Monnet I, Moro-Sibilot D, Cadranel J, Clement-Duchene C, Cousin S, Ricordel C, Merle P, Otto J, Schneider S, Langlais A, Morin F, Westeel V, Girard N. Lorlatinib for advanced anaplastic lymphoma kinase-positive non-small cell lung cancer: Results of the IFCT-1803 LORLATU cohort. Eur J Cancer. 2022 May;166:51-59. doi: 10.1016/j.ejca.2022.01.018. Epub 2022 Mar 9.

oa_host_type: publisher

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

unpaywall_oa_status: hybrid

sponsor_collaborators: Intergroupe Francophone de Cancerologie Thoracique

location_facility: Saint-Nazaire - Clinique Mutualiste de l'Estuaire


title: Multicenter Prospective Single Arm Phase II Study Evaluating Efficacy & Safety of Durvalumab With Carboplatin/Paclitaxel as First Line Treatment in Patients With Recurrent/Metastatic SCCHN Not Eligible to Standard Chemotherapy

acronym: FRAIL-IMMUNE

summary: The primary objective of the phase II trial is to determine the efficacy and safety of a combination of Durvalumab with the Carboplatin/Paclitaxel as first line treatment in patients with recurrent/metastatic SCCHN not eligible to standard chemotherapy.

location_facility: Institut de Cancérologie de Lorraine Alexis Vautrin


acronym: REGIRI

summary: Trial evaluating the efficacy of regorafenib combined with irinotecan compared to irinotecan alone in second-line treatment of patients with metastatic gastro-oesophageal adenocarcinomas.

sponsor_collaborators: UNICANCER Bayer

location_facility: Institut de Cancérologie de l'Ouest-Paul Papin

location_facility: Institut de Cancérologie de l'Ouest-René Gauducheau

location_facility: Centre de Cancérologie du Grand Montpellier

status: Terminated

title: A Randomised Phase 2 Trial Assessing REGorafenib Combined With IRInotecan as Second-line Treatment in Patients With Metastatic Gastro-oesophageal Adenocarcinomas

ipd_sharing_description: Individual Participant Data will not be shared at an individual level, they will be part of the study database including all enrolled patients


title: CHARACTERISTICS OF ADULT PATIENTS TREATED WITH CRIZOTINIB FOR ADVANCED NON-SMALL-CELL LUNG CANCER (NSCLC) WITH ALK GENE REARRANGEMENT OR ROS1 GENE REARRANGEMENT IN GENERAL HOSPITALS.

summary:
Descriptive Observational Study.

Characteristics Of ALK-positive and ROS1-positive Adults Patients Non-Small Cell Lung Cancer (NSCLC) Treated With Crizotinib Within General Hospitals

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

collaborators: French College of General Hospital Pneumologists (CPHG)

location_facility: Hopital Europeen - Service de Pneumologie

location_facility: Centre Hospitalier de Troyes, Service de Pneumologie - Oncologie Thoracique

location_facility: Hopitaux Civils de Colmar - Hopital Louis Pasteur

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: Centre Hospitalier Chalon sur Saone William Morey

location_facility: Centre Hospitalier Metropole de Savoie-Site de Chambery

location_facility: Centre Hospitalier de Villefranche sur Saone - BP80436

location_facility: Centre Hospitalier General Beziers, Service De Pneumologie

location_facility: Hopital Robert Ballanger, Service de Pneumologie

location_facility: Centre Hospitalier de l'Agglomeration de Nevers

location_facility: Centre Hospitalier Intercommunal du Pays d'Aix-Pertuis,Service de Pneumologie

location_facility: Centre Hospitalier des Deux Vallees - Longjumeau BP 125


title: A Multicenter Randomized Clinical Trial Comparing Two Treatment Strategies to Prevent Rebleeding From Gastric Varices: "Early TIPS" Versus Glue Obliteration

acronym: GAVAPROSEC

summary: The primary objective of the study is to demonstrate the superiority of an "early tips" strategy over standard treatment by glue obliteration (G0) in preventing bleeding recurrence or death at one year after a non GOV1 gastric variceal bleeding in cirrhotic patients initially treated by GO.

lead_sponsor: Centre Hospitalier Universitaire de Besancon

location_facility:
CHRU Brest
Pitié Salpétrière Hospital
University Hospital of Bordeaux
University Hospital of Tours
CHU Lyon
CHU Amiens
University Hospital of Angers
University Hospital of Dijon
University Hospital of Rennes
University Hospital of Nantes
University Hospital of Besançon
University Hospital of Toulouse
University Hospital of Marseille
University Hospital of Caen
Paul Brousse Hospital
University Hospital of Lille
Univerity Hospital of Bondy
St Antoine Hospital
University Hospital of Montpellier
University Hospital of Nice

intervention_type: Procedure

region: Bourgogne-Franche-Comté

nom_etablissement: CHU BESANCON

type_etablissement: CH

acronyme: GAVAPROSEC

titre: Essai randomisé multicentrique comparant deux stratégies pour prévenir la récidive hémorragique après rupture de varices gastriques: shunt porto systémique précoce par voie transjugulaire (TIPS) versus obturation à la colle

discipline_principale: hépatologie

nom_porteur: Cervoni

prenom_porteur: Jean Paul


title: Durvalumab Plus Tremelimumab Combination Immunotherapy With or Without Weekly Paclitaxel in Patients With Advanced Biliary Tract Carcinoma (BTC) After Failure of Platinum-based Chemotherapy: a Randomized Non-comparative Two-arm Phase II Study

acronym: IMMUNO-BIL

summary:
IMMUNO-BIL is a non-comparative randomized 1:1 phase II study. This study will assess the efficacy and safety of the combination of durvalumab plus tremelimumab with or without weekly paclitaxel in patients with advanced BTC after failure of platinum-based chemotherapy.

On the 25th June 2019, the maximum DLT event number was reached (6/10) in the durvalumab plus tremelimumab combination with paclitaxel Arm (Arm B). According to the Pocock boundary described in the protocol, GERCOR has updated the study to discontinue enrollment in Arm B (durvalumab plus tremelimumab with paclitaxel) . No safety concerns were raised by the IDMC in Arm A. Consequently, the study will resume with Arm A (durvalumab plus tremelimumab) only, without randomization.

Discontinuation of ARM B(June 2019): Durvalumab plus tremelimumab plus paclitaxel

One cycle equals 4 weeks (D1=D28); Durvalumab: 1,500 mg by IV infusion on D1, until progression or unacceptable toxicity or withdrawal of consent.

Tremelimumab: 75 mg by IV infusion on D1 for the first 4 cycles. Paclitaxel: 80 mg/m2, every week for 3 weeks (D1-D8-D15), by IV infusion, until progression or unacceptable toxicity or withdrawal of consent (at least 6 cycles, at the discretion of the investigator).

December 2020: Tremelimumab dosage modification based on the results of the Study 22 study (Kelley RK, et al. ASCO20 Virtual Scientific Program 2020) showing increased efficacy (response rate and progression-free survival) without safety concerns with one dose of tremelimumab 300 mg (cycle 1) instead of four doses of 75 mg (cycle 1 to cycle 4) in combination with durvalumab 1,500 mg Q4W in hepatocellular carcinoma. Following these results, we have changed the tremelimumab 75 mg x 4 schedule for the 300 mg x 1 schedule. The inclusion of 106 additional patients will be required to adequately evaluate the efficacy of this administration schedule.

ARM A : Durvalumab plus tremelimumab ( patients included before 31/12/2020) One cycle equals 4 weeks (D1=D28);

Durvalumab: 1,500 mg by IV infusion on D1, until progression or unacceptable toxicity or withdrawal of consent.

Tremelimumab: 75 mg by IV infusion on D1 for the first 4 cycles.

ReferenceCitation: Boileve A, Hilmi M, Gougis P, Cohen R, Rousseau B, Blanc JF, Ben Abdelghani M, Castanie H, Dahan L, Tougeron D, Metges JP, Tournigand C, Garcia-Larnicol ML, Vernerey D, Turpin A, Neuzillet C. Triplet combination of durvalumab, tremelimumab, and paclitaxel in biliary tract carcinomas: Safety run-in results of the randomized IMMUNOBIL PRODIGE 57 phase II trial. Eur J Cancer. 2021 Jan;143:55-63. doi: 10.1016/j.ejca.2020.10.027. Epub 2020 Dec 3.

sponsor_collaborators: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility:
Centre Léon Bérard
CHRU Jean Minjoz
Institut Mutualiste Montsouris
Institut Hospitalier franco-Britannique
Centre Eugène Marquis
Institut Curie
Insitut Gustave Roussy
Hôpital Saint Eloi
CHU Morvan
CHU Henri Mondor
CHU Dijon
Hôpital Privé Jean Mermoz
CHU Robert Debré
Centre Paul Strauss
Centre Georges François Leclerc
Hôpital Cochin
CHRU Lille
CHI Poissy Saint Germain
Hôpital la Timone
Hôpital Saint Antoine
CHPSO Site de Creil
Institut Andrée Dutreix
CHU Poitiers
Hôpital Beaujon
Hôpital Haut Lévêque
Hôpital Prive du confluent SAS
Hôpital Duchenne
Polyclinique Bordeaux Nord Aquitaine


title: Cost-utility Analysis of Maintenance rTMS for Treatment-resistant Depression

acronym: ACOUSTIM

summary: Treatment resistant depression (TRD) is a frequent, debilitating condition mostly treated by antidepressants. Repeated magnetic transcranial stimulation (rTMS) has proven adjuvant efficacy in TRD in the acute phase of treatment with a very good tolerance and acceptability. Maintenance rTMS (mTMS) is a strategy consisting in adding regular single TMS sessions after response to an acute course in order to keep the benefit of initial treatment over several month or years. Demonstrating that rTMS is efficient to improve long-term prognosis and decrease economic burden would have a tremendous impact in clinical practice in psychiatry. Thus the investigator's aim is to analyze the long term impact of mTMS treatment on costs, but also quality of life and clinical issues.

ReferenceCitation: Bulteau S, Laurin A, Volteau C, Dert C, Lagalice L, Schirr-Bonnans S, Bukowski N, Guitteny M, Simons L, Cabelguen C, Pichot A, Tessier F, Bonnin A, Lepage A; ACOUSTIM Investigators Group; HUGOPSY Network; Vanelle JM, Sauvaget A, Riche VP. Cost-utility analysis of curative and maintenance repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant unipolar depression: a randomized controlled trial protocol. Trials. 2020 Apr 5;21(1):312. doi: 10.1186/s13063-020-04255-9.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Francois Rabelais - Tours

lead_sponsor: Nantes University Hospital

location_facility: Centre hospitalier Guillaume Regnier Rennes

appel_a_projets: PRME

region: Pays de la Loire

nom_etablissement: CHU DE NANTES

acronyme: ACOUSTIM

titre: Analyse coût-utilité de la stimulation magnétique transcranienne (rTMS) curative et de maintenance dans le traitement de la dépression résistante.

discipline_principale: psychiatrie / addictologie

nom_porteur: Bulteau

prenom_porteur: Samuel


title: Impact of Cardiovascular Rehabilitation on the Quality of Life of Adolescents and Young Adults With Congenital Heart Disease: A Randomized Controlled Multicentre Trial

acronym: QUALIREHAB

summary: The investigators aim to measure the impact of a rehabilitation program in congenital cardiology in terms of health related quality of life. The orginality of the rehabilitation program consists in its design : initial hospitalizationfor a short period of time (5 days) at the rehabilitation center, followed by 11 weeks of rehabilitation at home under the supervision of a specialized sports trainer.

ReferenceCitation: Amedro P, Gavotto A, Legendre A, Lavastre K, Bredy C, De La Villeon G, Matecki S, Vandenberghe D, Ladeveze M, Bajolle F, Bosser G, Bouvaist H, Brosset P, Cohen L, Cohen S, Corone S, Dauphin C, Dulac Y, Hascoet S, Iriart X, Ladouceur M, Mace L, Neagu OA, Ovaert C, Picot MC, Poirette L, Sidney F, Soullier C, Thambo JB, Combes N, Bonnet D, Guillaumont S. Impact of a centre and home-based cardiac rehabilitation program on the quality of life of teenagers and young adults with congenital heart disease: The QUALI-REHAB study rationale, design and methods. Int J Cardiol. 2019 May 15;283:112-118. doi: 10.1016/j.ijcard.2018.12.050. Epub 2018 Dec 20.

lead_sponsor: University Hospital, Montpellier

location_facility: Haut Lévêques - Bordeaux University Hospital

location_facility: Children and Mother Hospital - Limoges University Hospital

location_facility: Children Hospital - Toulouse University Hospital

location_facility: Gabriel Montpied Hospital- Clermont Ferrand University Hospital

location_facility: Barbois Hospital - Nancy University Hospital

location_facility: Arnaud de Villeneuve - University Hospital

location_facility: La Miletrie -Poitier University Hospital

location_facility: La Timone- Public Assistance - Marseille hospitals

appel_a_projets: PHRCI

region: Occitanie

nom_etablissement: CHU MONTPELLIER

acronyme: REHAB CHD

titre: Impact de la réhabilitation cardiovasculaire sur la qualité de vie des enfants et adultes porteurs de cardiopathies congénitales : essai multicentrique randomisé contrôlé

discipline_principale: cardiologie pédiatrique et congénitale, réhabilitation, essais cliniques

nom_porteur: GUILLAUMONT

prenom_porteur: Sophie


title: Women's Evaluation of the Childbirth Experience: From Pregnancy to Postpartum

acronym: EVA (ECE)

summary: Women report inappropriate health professional behaviour towards them during pregnancy or childbirth on social networks. However, to date, no data are available to estimate the number of women concerned. These data are necessary to characterize these behaviours to get out of this polemic and build a reflection on the improvement of the patient relationship and the emotional security of women.

lead_sponsor: Hospices Civils de Lyon

location_facility: CH de BOURG EN BRESSE - Pôle Mère Enfant

location_facility: Réseau AURORE, service de gynécologie Obstétrique, Hôpital de la Croix-Rousse

location_facility: Polyclinique Lyon Nord Service Maternité (NATECIA)

location_facility: Hôpital Privé Drôme Ardèche Clinique Pasteur

location_facility: Centre Hospitalier de Villefranche Sur Saône Hôpital Nord-Ouest

location_facility: Centre Hospitalier de Sainte Foy les Lyon


title: Multicenter Open Label Phase 2 Single Arm Study of Ixazomib, Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Characterized With Genomic Abnormalities of Adverse Adverse Prognostic

summary: This study is a Multicenter, Open-label, Phase II study of ixazomib, plus Pomalidomide and Dexamethasone regimen (IPD) in RRMM with adverse Genomic Abnormalities.

ReferenceCitation: Assouline, S., et al. Once-weekly MLN9708, an investigational proteasome inhibitor, in patients with relapsed/refractory lymphoma: results of a phase 1 dose-escalation study in 17th EHA Annual Congress. 2012. Amsterdam, the Netherlands

ReferenceCitation: Avet-Loiseau H, Attal M, Moreau P, Charbonnel C, Garban F, Hulin C, Leyvraz S, Michallet M, Yakoub-Agha I, Garderet L, Marit G, Michaux L, Voillat L, Renaud M, Grosbois B, Guillerm G, Benboubker L, Monconduit M, Thieblemont C, Casassus P, Caillot D, Stoppa AM, Sotto JJ, Wetterwald M, Dumontet C, Fuzibet JG, Azais I, Dorvaux V, Zandecki M, Bataille R, Minvielle S, Harousseau JL, Facon T, Mathiot C. Genetic abnormalities and survival in multiple myeloma: the experience of the Intergroupe Francophone du Myelome. Blood. 2007 Apr 15;109(8):3489-95. doi: 10.1182/blood-2006-08-040410. Epub 2007 Jan 5.

ReferenceCitation: Avet-Loiseau H, Attal M, Campion L, Caillot D, Hulin C, Marit G, Stoppa AM, Voillat L, Wetterwald M, Pegourie B, Voog E, Tiab M, Banos A, Jaubert J, Bouscary D, Macro M, Kolb B, Traulle C, Mathiot C, Magrangeas F, Minvielle S, Facon T, Moreau P. Long-term analysis of the IFM 99 trials for myeloma: cytogenetic abnormalities [t(4;14), del(17p), 1q gains] play a major role in defining long-term survival. J Clin Oncol. 2012 Jun 1;30(16):1949-52. doi: 10.1200/JCO.2011.36.5726. Epub 2012 Apr 30.

ReferenceCitation: Avet-Loiseau H, Leleu X, Roussel M, Moreau P, Guerin-Charbonnel C, Caillot D, Marit G, Benboubker L, Voillat L, Mathiot C, Kolb B, Macro M, Campion L, Wetterwald M, Stoppa AM, Hulin C, Facon T, Attal M, Minvielle S, Harousseau JL. Bortezomib plus dexamethasone induction improves outcome of patients with t(4;14) myeloma but not outcome of patients with del(17p). J Clin Oncol. 2010 Oct 20;28(30):4630-4. doi: 10.1200/JCO.2010.28.3945. Epub 2010 Jul 19.

ReferenceCitation: Bergsagel PL, Mateos MV, Gutierrez NC, Rajkumar SV, San Miguel JF. Improving overall survival and overcoming adverse prognosis in the treatment of cytogenetically high-risk multiple myeloma. Blood. 2013 Feb 7;121(6):884-92. doi: 10.1182/blood-2012-05-432203. Epub 2012 Nov 19.

ReferenceCitation: Chauhan D, Tian Z, Zhou B, Kuhn D, Orlowski R, Raje N, Richardson P, Anderson KC. In vitro and in vivo selective antitumor activity of a novel orally bioavailable proteasome inhibitor MLN9708 against multiple myeloma cells. Clin Cancer Res. 2011 Aug 15;17(16):5311-21. doi: 10.1158/1078-0432.CCR-11-0476. Epub 2011 Jun 30.

ReferenceCitation: Chow, L.Q., et al. MLN9708, an investigational proteasome inhibitor, in patients with solid tumors; Updated phase 1 results in Head and Neck Symposium. 2012. Phoenix, AZ

ReferenceCitation: Munshi NC, Anderson KC, Bergsagel PL, Shaughnessy J, Palumbo A, Durie B, Fonseca R, Stewart AK, Harousseau JL, Dimopoulos M, Jagannath S, Hajek R, Sezer O, Kyle R, Sonneveld P, Cavo M, Rajkumar SV, San Miguel J, Crowley J, Avet-Loiseau H; International Myeloma Workshop Consensus Panel 2. Consensus recommendations for risk stratification in multiple myeloma: report of the International Myeloma Workshop Consensus Panel 2. Blood. 2011 May 5;117(18):4696-700. doi: 10.1182/blood-2010-10-300970. Epub 2011 Feb 3.

ReferenceCitation: Debes-Marun CS, Dewald GW, Bryant S, Picken E, Santana-Davila R, Gonzalez-Paz N, Winkler JM, Kyle RA, Gertz MA, Witzig TE, Dispenzieri A, Lacy MQ, Rajkumar SV, Lust JA, Greipp PR, Fonseca R. Chromosome abnormalities clustering and its implications for pathogenesis and prognosis in myeloma. Leukemia. 2003 Feb;17(2):427-36. doi: 10.1038/sj.leu.2402797.

ReferenceCitation: Dewald GW, Therneau T, Larson D, Lee YK, Fink S, Smoley S, Paternoster S, Adeyinka A, Ketterling R, Van Dyke DL, Fonseca R, Kyle R. Relationship of patient survival and chromosome anomalies detected in metaphase and/or interphase cells at diagnosis of myeloma. Blood. 2005 Nov 15;106(10):3553-8. doi: 10.1182/blood-2005-05-1981. Epub 2005 Jul 19.

ReferenceCitation: Dimopoulos M, Spencer A, Attal M, Prince HM, Harousseau JL, Dmoszynska A, San Miguel J, Hellmann A, Facon T, Foa R, Corso A, Masliak Z, Olesnyckyj M, Yu Z, Patin J, Zeldis JB, Knight RD; Multiple Myeloma (010) Study Investigators. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007 Nov 22;357(21):2123-32. doi: 10.1056/NEJMoa070594. Erratum In: N Engl J Med. 2009 Jul 30;361(5):544.

ReferenceCitation: Durie BG, Harousseau JL, Miguel JS, Blade J, Barlogie B, Anderson K, Gertz M, Dimopoulos M, Westin J, Sonneveld P, Ludwig H, Gahrton G, Beksac M, Crowley J, Belch A, Boccadaro M, Cavo M, Turesson I, Joshua D, Vesole D, Kyle R, Alexanian R, Tricot G, Attal M, Merlini G, Powles R, Richardson P, Shimizu K, Tosi P, Morgan G, Rajkumar SV; International Myeloma Working Group. International uniform response criteria for multiple myeloma. Leukemia. 2006 Sep;20(9):1467-73. doi: 10.1038/sj.leu.2404284. Epub 2006 Jul 20. Erratum In: Leukemia. 2006 Dec;20(12):2220. Leukemia. 2007 May;21(5):1134.

ReferenceCitation: Fonseca R, Blood E, Rue M, Harrington D, Oken MM, Kyle RA, Dewald GW, Van Ness B, Van Wier SA, Henderson KJ, Bailey RJ, Greipp PR. Clinical and biologic implications of recurrent genomic aberrations in myeloma. Blood. 2003 Jun 1;101(11):4569-75. doi: 10.1182/blood-2002-10-3017. Epub 2003 Feb 6.

ReferenceCitation: Gertz MA, Lacy MQ, Dispenzieri A, Greipp PR, Litzow MR, Henderson KJ, Van Wier SA, Ahmann GJ, Fonseca R. Clinical implications of t(11;14)(q13;q32), t(4;14)(p16.3;q32), and -17p13 in myeloma patients treated with high-dose therapy. Blood. 2005 Oct 15;106(8):2837-40. doi: 10.1182/blood-2005-04-1411. Epub 2005 Jun 23.

ReferenceCitation: Gupta, N., M. Saleh, and K. Venkatakrishnan. Flat-Dosing Versus BSA-Based Dosing for MLN9708, An Investigational Proteasome Inhibitor: Population Pharmacokinetic (PK) Analysis of Pooled Data From 4 Phase-1 Studies in 53rd ASH Annual Meeting and Exposition. 2011. San Diego, CA; p. abstr 1433

ReferenceCitation: Gupta, N., et al., Clinical Pharmacokinetics of Intravenous and Oral MLN9708, An Investigational Proteasome Inhibitor: An Analysis of Data From Four Phase 1 Monotherapy Studies. in 52nd ASH Annual Meeting and Exposition, 2010. 116(21): p. abstr 1813.

ReferenceCitation: Jagannath S, Richardson PG, Sonneveld P, Schuster MW, Irwin D, Stadtmauer EA, Facon T, Harousseau JL, Cowan JM, Anderson KC. Bortezomib appears to overcome the poor prognosis conferred by chromosome 13 deletion in phase 2 and 3 trials. Leukemia. 2007 Jan;21(1):151-7. doi: 10.1038/sj.leu.2404442. Epub 2006 Nov 9.

ReferenceCitation: Kumar SK, Lee JH, Lahuerta JJ, Morgan G, Richardson PG, Crowley J, Haessler J, Feather J, Hoering A, Moreau P, LeLeu X, Hulin C, Klein SK, Sonneveld P, Siegel D, Blade J, Goldschmidt H, Jagannath S, Miguel JS, Orlowski R, Palumbo A, Sezer O, Rajkumar SV, Durie BG; International Myeloma Working Group. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012 Jan;26(1):149-57. doi: 10.1038/leu.2011.196. Epub 2011 Jul 29. Erratum In: Leukemia. 2012 May;26(5):1153. Nari, Hareth [corrected to Nahi, Hareth].

ReferenceCitation: Kumar SK, Berdeja JG, Niesvizky R, et al. A phase 1/2 study of weekly MLN9708, an investigational oral proteasome inhibitor, in combination with lenalidomide and dexamethasone in patients with previously untreated multiple myeloma (MM). Blood. 2012;120(21):332 (abstract 332).

ReferenceCitation: Kumar S, Niesvizky R, Berdeja J, Bensinger W, Zimmerman T, Berenson J, et al. Safety and Pharmacokinetics of Weekly MLN9708, an Investigational Oral Proteasome Inhibitor, Alone and in Combination. Clinical Lymphoma Myeloma and Leukemia 2013;13(Supplement 1):S154; abstr P-230

ReferenceCitation: Kumar S, Bensinger W, Reeder C, Zimmerman T, Berenson J, Liu G, et al. Weekly dosing of the investigational oral proteasome inhibitor MLN9708 in patients (pts) with relapsed/refractory multiple myeloma (MM): A phase I study. Journal of Clinical Oncology 2012 ASCO Annual Meeting Proceedings 2012:Abstract 8034.

ReferenceCitation: Kumar S, Bensinger W, Reeder C, Zimmerman T, Berenson J, Berg D, et al. Weekly Dosing of the Investigational Oral Proteasome Inhibitor MLN9708 in Patients with Relapsed and/or Refractory Multiple Myeloma: Results From a Phase 1 Dose- Escalation Study In: 53rd ASH Annual Meeting and Exposition; 2011 10-13 Dec; San Diego, CA; p. abstr 816.

ReferenceCitation: Kumar, S. et al. A Phase 1/2 Study of Weekly MLN9708, an Investigational Oral Proteasome Inhibitor, in Combination with Lenalidomide and Dexamethasone in Patients with Previously Untreated Multiple Myeloma (MM) in 54th ASH Annual Meeting and Exposition. 2012. Atlanta, Georgia.

ReferenceCitation: Leleu X, Attal M, Arnulf B, Moreau P, Traulle C, Marit G, Mathiot C, Petillon MO, Macro M, Roussel M, Pegourie B, Kolb B, Stoppa AM, Hennache B, Brechignac S, Meuleman N, Thielemans B, Garderet L, Royer B, Hulin C, Benboubker L, Decaux O, Escoffre-Barbe M, Michallet M, Caillot D, Fermand JP, Avet-Loiseau H, Facon T; Intergroupe Francophone du Myelome. Pomalidomide plus low-dose dexamethasone is active and well tolerated in bortezomib and lenalidomide-refractory multiple myeloma: Intergroupe Francophone du Myelome 2009-02. Blood. 2013 Mar 14;121(11):1968-75. doi: 10.1182/blood-2012-09-452375. Epub 2013 Jan 14.

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Hematology

ReferenceCitation: Lonial S, Baz R, Wang M, Talpaz M, Liu G, Berg D, et al. Phase I study of twice weekly dosing of the investigational oral proteasome inhibitor MLN9708 in patients (pts) with relapsed and/or refractory multiple myeloma (MM). J Clin Oncol (ASCO Meeting Abstracts) 2012;30(15 suppl):abstr 8017.

ReferenceCitation: Merlini, G., et al. MLN9708, a Novel, Investigational Oral Proteasome Inhibitor, in Patients with Relapsed or Refractory Light-Chain Amyloidosis (AL): Results of a Phase 1 Study in 54th ASH Annual Meeting and Exposition. 2012. Atlanta, Georgia

ReferenceCitation: Moreau P, Attal M, Garban F, Hulin C, Facon T, Marit G, Michallet M, Doyen C, Leyvraz S, Mohty M, Wetterwald M, Mathiot C, Caillot D, Berthou C, Benboubker L, Garderet L, Chaleteix C, Traulle C, Fuzibet JG, Jaubert J, Lamy T, Casassus P, Dib M, Kolb B, Dorvaux V, Grosbois B, Yakoub-Agha I, Harousseau JL, Avet-Loiseau H; SAKK; IFM Group. Heterogeneity of t(4;14) in multiple myeloma. Long-term follow-up of 100 cases treated with tandem transplantation in IFM99 trials. Leukemia. 2007 Sep;21(9):2020-4. doi: 10.1038/sj.leu.2404832. Epub 2007 Jul 12.

ReferenceCitation: Rajkumar SV, Harousseau JL, Durie B, Anderson KC, Dimopoulos M, Kyle R, Blade J, Richardson P, Orlowski R, Siegel D, Jagannath S, Facon T, Avet-Loiseau H, Lonial S, Palumbo A, Zonder J, Ludwig H, Vesole D, Sezer O, Munshi NC, San Miguel J; International Myeloma Workshop Consensus Panel 1. Consensus recommendations for the uniform reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1. Blood. 2011 May 5;117(18):4691-5. doi: 10.1182/blood-2010-10-299487. Epub 2011 Feb 3.

ReferenceCitation: Rajkumar SV. Multiple myeloma: 2013 update on diagnosis, risk-stratification, and management. Am J Hematol. 2013 Mar;88(3):226-35. doi: 10.1002/ajh.23390. Erratum In: Am J Hematol. 2014 Jun;89(6):669.

ReferenceCitation: Reece D, Song KW, Fu T, Roland B, Chang H, Horsman DE, Mansoor A, Chen C, Masih-Khan E, Trieu Y, Bruyere H, Stewart DA, Bahlis NJ. Influence of cytogenetics in patients with relapsed or refractory multiple myeloma treated with lenalidomide plus dexamethasone: adverse effect of deletion 17p13. Blood. 2009 Jul 16;114(3):522-5. doi: 10.1182/blood-2008-12-193458. Epub 2009 Mar 30.

ReferenceCitation: Richardson PG, Barlogie B, Berenson J, Singhal S, Jagannath S, Irwin D, Rajkumar SV, Srkalovic G, Alsina M, Alexanian R, Siegel D, Orlowski RZ, Kuter D, Limentani SA, Lee S, Hideshima T, Esseltine DL, Kauffman M, Adams J, Schenkein DP, Anderson KC. A phase 2 study of bortezomib in relapsed, refractory myeloma. N Engl J Med. 2003 Jun 26;348(26):2609-17. doi: 10.1056/NEJMoa030288.

ReferenceCitation: Richardson PG, Siegel D, Baz R, Kelley SL, Munshi NC, Laubach J, Sullivan D, Alsina M, Schlossman R, Ghobrial IM, Doss D, Loughney N, McBride L, Bilotti E, Anand P, Nardelli L, Wear S, Larkins G, Chen M, Zaki MH, Jacques C, Anderson KC. Phase 1 study of pomalidomide MTD, safety, and efficacy in patients with refractory multiple myeloma who have received lenalidomide and bortezomib. Blood. 2013 Mar 14;121(11):1961-7. doi: 10.1182/blood-2012-08-450742. Epub 2012 Dec 14.

ReferenceCitation: Richardson P, Baz R, Wang L, Jakubowiak A, Berg D, Liu G, et al. Investigational Agent MLN9708, An Oral Proteasome Inhibitor, in Patients (Pts) with Relapsed and/or Refractory Multiple Myeloma (MM): Results From the Expansion Cohorts of a Phase 1 Dose-Escalation Study In: 53rd ASH Annual Meeting and Exposition; 2011 10-13 Dec; San Diego, CA; p. abstr 301.

ReferenceCitation: Richardson, P.G., et al. MLN9708, an investigational proteasome inhibitor, in combination with lenalidomide and dexamethasone in previously untreated multiple myeloma patients (pts): Evaluation of weekly and twice-weekly dosing in 17th EHA Annual Congress. 2012. Amsterdam, the Netherlands

ReferenceCitation: San Miguel, J., et al. Oral MLN9708, an an investigational proteasome inhibitor, in combination with melphalan and prednisone in patients with previously untreated multiple myeloma: a phase 1 study in 17th EHA Annual Congress. 2012. Amsterdam, the Netherlands.

ReferenceCitation: Sonneveld P, Schmidt-Wolf IG, van der Holt B, El Jarari L, Bertsch U, Salwender H, Zweegman S, Vellenga E, Broyl A, Blau IW, Weisel KC, Wittebol S, Bos GM, Stevens-Kroef M, Scheid C, Pfreundschuh M, Hose D, Jauch A, van der Velde H, Raymakers R, Schaafsma MR, Kersten MJ, van Marwijk-Kooy M, Duehrsen U, Lindemann W, Wijermans PW, Lokhorst HM, Goldschmidt HM. Bortezomib induction and maintenance treatment in patients with newly diagnosed multiple myeloma: results of the randomized phase III HOVON-65/ GMMG-HD4 trial. J Clin Oncol. 2012 Aug 20;30(24):2946-55. doi: 10.1200/JCO.2011.39.6820. Epub 2012 Jul 16. Erratum In: J Clin Oncol. 2012 Oct 10;30(29):3654.

ReferenceCitation: Stewart AK, Fonseca R. Review of molecular diagnostics in multiple myeloma. Expert Rev Mol Diagn. 2007 Jul;7(4):453-9. doi: 10.1586/14737159.7.4.453.

ReferenceCitation: Weber DM, Chen C, Niesvizky R, Wang M, Belch A, Stadtmauer EA, Siegel D, Borrello I, Rajkumar SV, Chanan-Khan AA, Lonial S, Yu Z, Patin J, Olesnyckyj M, Zeldis JB, Knight RD; Multiple Myeloma (009) Study Investigators. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med. 2007 Nov 22;357(21):2133-42. doi: 10.1056/NEJMoa070596.

lead_sponsor: Intergroupe Francophone du Myelome

sponsor_collaborators:
Intergroupe Francophone du Myelome
AXONAL
Nantes University Hospital
University Hospital, Grenoble
Euraxi Pharma
QPS Holdings LLC
Bristol-Myers Squibb
Takeda

location_facility: Centre hospitalier départemental de Vendée

location_facility: Institut de cancérologie Strasbourg Europe (ICANS)

location_facility: Institut Universitaire du Cancer de Toulouse Oncopole

location_facility: CH Avignon - Centre Hospitalier H.Duffaut


acronym: EFFICACI

lead_sponsor: Rennes University Hospital

summary:
Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) that results from immune dysregulation. Arguably, the development of Tumor Necrosis Factor (TNF) antagonists (including infliximab, adalimumab and golimumab) revolutionized the management of immune-mediated chronic diseases in the past two decades.

However, about one third of patients will not respond to a first anti-TNF treatment and 10% to 30% will loose response to anti-TNF during the follow-up.

Historically, a switch between anti-TNF was performed to recapture remission and response to anti-TNF. Recently, a new biologic therapy blocking another target has been approved and is now reimbursed during ulcerative colitis, namely vedolizumab. Vedolizumab is an anti-integrin agent avoiding the recruitment of lymphocytes specifically in inflamed gut tissue.

Emerging data suggest that a switch of therapeutic class (meaning a change of biologic target with Non-TNF-targeted biologic) in case of clinical failure or insufficient response to anti-TNF may be the best choice. This idea of a switch out of the anti-TNF class is also supported by data on drug monitoring that may help physician decision making in case of loss of response. However, no trial is currently available and ongoing to assess the best therapeutic strategy. The aim of the proposed study is to assess the best biological based strategy in patient losing response to a first subcutaneous anti-TNF (golimumab and/or adalimumab).

location_facility: Centre Hospitalier Universitaire de Besançon

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Centre Hospitalier Universitaire de Strasbourg

location_facility: Assistance Publique des Hôpitaux de Paris - Hôpital Henri Mondor

location_facility: Centre Hospitalier Universitaire de Saint-Etienne

location_facility: Assistance Publique des Hôpitaux de Paris - Hôpital Saint-Louis

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Centre Hospitalier Universitaire de Caen

location_facility: Centre Hospitalier Universitaire d'Amiens-Picardie

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Assistance Publique des Hôpitaux de Marseille

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: Centre Hospitalier Universitaire de Lille

location_facility: Centre Hospitalier Universitaire de Nancy

location_facility: Centre Hospitalier Universitaire de Montpellier

location_facility: Assistance Publique des Hôpitaux de Paris - Hôpital Beaujon

title: EFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative Colitis : A Double Blinded Randomized Clinical Trial

region: Bretagne

nom_etablissement: CHRU RENNES

acronyme: EFFICACI

titre: Efficacité d'un traitement par infliximab en comparaison au vedolizumab chez les patients en échec d'un traitement anti-TNF sous-cutanée au cours de la rectocolite hémorragique: essai randomisé contrôlé en aveugle

discipline_principale: gastroenterology

nom_porteur: BOUGUEN

prenom_porteur: Guillaume


title: Phase III Randomised Trial Evaluating Treatment Intensification With Temozolomide in Adults With a Glioblastoma

acronym: StrateGlio

summary: Due to conflicting data on the optimal moment to start TMZ chemotherapy and the impact of prolongation of the adjuvant phase with TMZ, the ANOCEF (Association des Neuro-Oncologues d'Expression Francophone) group proposes this randomized trial comparing an intensified arm (early TMZ and extended adjuvant TMZ until toxicity, progression or patient refusal) versus the classical EORTC regimen as control (RT and concomitant TMZ started 4-6 weeks after surgery followed by a number of adjuvant TMZ cycles strictly limited to 6) for primary GBM adult patients.

collaborators: Association de Neuro-Oncologues d'Expression Francaise

location_facility:
ICM Val d'Aurelle
Institut Cancérologie Loire
Centre Léon Bérard
CHU de Nice - Hôpital de Cimiez
CHU Grenoble Alpes
APHP La Pitié Salpêtrière
CHU La Timone
CHRU Tours
Centre Paul Strauss
Centre Georges François Leclerc
Centre Jean Perrin
Hôpitaux Civils de Colmar
CHRU Nancy
Centre Hospitalier d'Amiens
Centre François Baclesse
ICO Centre René Gauducheau
ICO Centre Paul Papin
CHU de Limoges
CH René Dubos


title: A Multicentric Randomized Phase II/III Evaluating TSR-042 (Anti-PD-1 mAb) in Combination With Niraparib (Parpi) Versus Niraparib Alone Compared to Chemotherapy in the Treatment of Metastatic or Recurrent Endometrial or Ovarian Carcinosarcoma After at Least One Line of Chemotherapy

acronym: ROCSAN

summary: Carcinosarcomas (CS) (malignant mixed Müllerian tumors) are highly aggressive and rare tumors with a worldwide annual incidence between 0.5-3.3 cases/100.000 women. Gynecological CS, i.e. ovarian CS (OCS) and uterine CS (UCS), have a 5-year overall survival (OS) < 10% and a poor prognosis. After initial treatment (surgery +/- adjuvant radiotherapies +/- chemotherapies (CT)), vast majority of patients relapsed and received diverse CT producing modest benefits, and nearly all patients will die. After first line CT including platinum salt, monotherapy (doxorubicin or paclitaxel) is frequently used for relapsed patients, but the response rate (RR) is <20%, progression-free survival (PFS) <4 months, and OS <1 year. In this unmet need situation, a better knowledge of these aggressive neoplasms is essential to propose new therapeutic options.

ipd_sharing_description: No sharing plan

sponsor_collaborators:
ARCAGY/ GINECO GROUP
Tesaro, Inc.

location_facility: Hopital Milétrie - Centre Hospitalier Universitaire Poitiers

location_facility: IUCT Oncopole - Institut Claudius Régaud

location_facility: Centre Régional de Lutte contre le cancer - Institut Bergonié

location_facility: Groupe Hospitalier des Diaconesses Croix Saint-Simon

location_facility: Institut Régional du Cancer de Montpellier (ICM Val d'Aurelle)


lead_sponsor: UNICANCER

summary: Trial evaluating the impact on efficacy of mifamurtide as add-on treatment to post-operative chemotherapy compared to post-operative chemotherapy alone in first-line treatment of patients with high-risk osteosarcoma (defined as metastatic osteosarcoma at diagnosis or localised osteosarcoma with poor histological response).

ReferenceCitation: Hattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14.

publisher_dissemination: Informa

ReferenceCitation: Brard C, Piperno-Neumann S, Delaye J, Brugieres L, Hampson LV, Le Teuff G, Le Deley MC, Gaspar N. Sarcome-13/OS2016 trial protocol: a multicentre, randomised, open-label, phase II trial of mifamurtide combined with postoperative chemotherapy for patients with newly diagnosed high-risk osteosarcoma. BMJ Open. 2019 May 19;9(5):e025877. doi: 10.1136/bmjopen-2018-025877.

license: cc-by-nc

license_normalized: cc-by-nc

publisher_dissemination: British Medical Journal

location_facility: Institut Gustave Roussy - Service d'oncologie médicale

location_facility: Hôpital Hautepierre - Onco-hématologie pédiatrique

location_facility: CHU Arnaud de Villeneuve - Onco-hématologie pédiatrique

location_facility: Centre Eugène Marquis - Service d'oncologie médicale

location_facility: Hôpital Charles Nicolle - Hémato-Immuno-Oncologie Pédiatrique

location_facility: Hôpital de la Timone - service d'oncologie médicale

location_facility: CHU d'Angers - Service d'oncologie pédiatrique

location_facility: CHU Toulouse - Hôpital des Enfants - Service d'Hémato-Immuno-Oncologie

location_facility: CHRU de Nancy - Onco-hématologie pédiatrique

location_facility: Institut Gustave Roussy - Service de cancérologie de l'enfant et de l'adolescent

location_facility: CHU de Grenoble - Service d'oncologie hématologie pédiatrique

location_facility: CHU de Caen - Service d'oncologie hématologie pédiatrique

location_facility: Institut Bergonié - Service d'oncologie médicale

location_facility: Institut Claudius Regaud - service d'oncologie médicale

location_facility: CHU Bretonneau - Service d'oncologie médicale

location_facility: Institut Curie - Service d'oncologie médicale

location_facility: Hôpital de Hautepierre - Onco-hématologie adulte

location_facility: Institut de Cancérologie de l'Ouest (Site René Gauducheau) - Service d'oncologie médicale

location_facility: Centre Oscar Lambret - Unité d'onco-pédiatrie

location_facility: Centre Léon Bérard - Service d'oncologie médicale

location_facility: Hôpital Clocheville - Hématologie et oncologie pédiatrique

location_facility: Institut de Cancérologie de Lorraine - Service d'oncologie médicale

location_facility: Institut régional du Cancer de Montpellier - Service d'oncologie médicale

location_facility: CHU de Nice - Service d'oncologie hématologie pédiatrique

location_facility: Hôpital Armand Trousseau - Service d'hématologie et d'oncologie pédiatrique

location_facility: CHU Amiens-Picardie - Service d'oncologie hématologie pédiatrique

location_facility: Hôpital de la Timone - Service d'oncologie pédiatrique

location_facility: Institut Curie - Service d'oncologie pédiatrique

location_facility: CHU de Nantes - Service d'oncologie hématologie pédiatrique

title: Multicentre, Randomised, Phase 2 Trial of Mifamurtide Combined With Post-operative Chemotherapy for Newly Diagnosed High Risk Osteosarcoma Patients (Metastatic Osteosarcoma at Diagnosis or Localised Disease With Poor Histological Response)

ipd_sharing_description: Individual participant data will not be shared at an individual level, they will be part of the study database including all enrolled patients.

titre: SARCOME 13  Phase 2 randomisée évaluant l'association du MEPACT à la chimiothérapie post-opératoire  dans les ostéosarcomes de haut risque nouvellement diagnostiqués (métastatiques ou localisés avec une mauvaise réponse histologique)

nom_porteur: GASPAR

prenom_porteur: Nathalie


title: Impact of 2 Transfusion Strategies on the Quality of Life of Multi-transfused Patients With Low Risk Myelodysplastic Syndrome: Multicenter Randomized Trial Comparing a Liberal vs. Restrictive Transfusion Regimen

acronym: SMD-transfu

summary:
Myelodysplastic syndromes (MDS) are heterogeneous malignant bone marrow disorders characterized by ineffective haematopoiesis, peripheral blood cytopenias and variable risk of leukaemia transformation.

Anemia is the most common manifestation of bone marrow failure in MDS. After failure with first-line treatment by Erythropoietin, patients survive in average 5 years under long term blood transfusion. Modalities of blood transfusion are not clearly defined.

Then, the objective of this randomized comparative multicentric study is to compare two modalities of threshold for transfusion:

Restrictive group: Hb < 80g/L and Hb maintain between 80 and 100g/L
Liberal group: Hb < 100g/L and Hb maintain between 100 and 120g/L

primary_purpose: Prevention

lead_sponsor: Lille Catholic University

location_facility:
Cote de Nacre CHU
Bordeaux CHU
Arras CH
Henri Duffaut CH
Abbeville CH
Meaux CH
Dunkerque CH
Le Mans CH
Saint-Louis Hospital, APHP
Amiens CHU
St-Vincent Hospital
Grenoble CHU
Besançon CHU
Limoges CHRU
Archet 1 Hospital
Pontchaillou Hospital
Clermont-Ferrand CHU
Lens CH
Roubaix CH


title: Evaluation of Perioperative Eltrombopag for the Management of Elective Surgery and Invasive Acts in Patients With Inherited Thrombocytopenia

acronym: ELPOT

summary: The objective of the study is to estimate the response to eltrombopag based on platelet count increase above a safety level of 80 G/L and lack of requirement for pre-, per- and post-operative administration of platelet concentrates (PC) for performing elective invasive acts at mild or high bleeding risk,in selected patients with inherited thrombocytopenia (IT).

ReferenceCitation: Pecci A, Gresele P, Klersy C, Savoia A, Noris P, Fierro T, Bozzi V, Mezzasoma AM, Melazzini F, Balduini CL. Eltrombopag for the treatment of the inherited thrombocytopenia deriving from MYH9 mutations. Blood. 2010 Dec 23;116(26):5832-7. doi: 10.1182/blood-2010-08-304725. Epub 2010 Sep 15.

ReferenceCitation: Pecci A. Pathogenesis and management of inherited thrombocytopenias: rationale for the use of thrombopoietin-receptor agonists. Int J Hematol. 2013 Jul;98(1):34-47. doi: 10.1007/s12185-013-1351-7. Epub 2013 May 1.

ReferenceCitation: Pecci A, Barozzi S, d'Amico S, Balduini CL. Short-term eltrombopag for surgical preparation of a patient with inherited thrombocytopenia deriving from MYH9 mutation. Thromb Haemost. 2012 Jun;107(6):1188-9. doi: 10.1160/TH12-01-0005. Epub 2012 Mar 8. No abstract available.

ReferenceCitation: Gerrits AJ, Leven EA, Frelinger AL 3rd, Brigstocke SL, Berny-Lang MA, Mitchell WB, Revel-Vilk S, Tamary H, Carmichael SL, Barnard MR, Michelson AD, Bussel JB. Effects of eltrombopag on platelet count and platelet activation in Wiskott-Aldrich syndrome/X-linked thrombocytopenia. Blood. 2015 Sep 10;126(11):1367-78. doi: 10.1182/blood-2014-09-602573. Epub 2015 Jul 29.

ReferenceCitation: Favier R, Feriel J, Favier M, Denoyelle F, Martignetti JA. First successful use of eltrombopag before surgery in a child with MYH9-related thrombocytopenia. Pediatrics. 2013 Sep;132(3):e793-5. doi: 10.1542/peds.2012-3807. Epub 2013 Aug 12.

ReferenceCitation: Fiore M, Saut N, Alessi MC, Viallard JF. Successful use of eltrombopag for surgical preparation in a patient with ANKRD26-related thrombocytopenia. Platelets. 2016 Dec;27(8):828-829. doi: 10.1080/09537104.2016.1190446. Epub 2016 Jun 8. No abstract available.

ReferenceCitation: Zhang J, Liang Y, Ai Y, Xie J, Li Y, Zheng W. Thrombopoietin-receptor agonists for children with immune thrombocytopenia: a systematic review. Expert Opin Pharmacother. 2017 Oct;18(15):1543-1551. doi: 10.1080/14656566.2017.1373091. Epub 2017 Sep 4.

lead_sponsor: University Hospital, Toulouse

collaborators: French network for inherited hemorragic diseases

collaborators: National Reference Centre for Platelet Pathologies

location_facility:
Rouen Hospital
Marseille Hospital
university hospital Toulouse
Robert Debré Hospital
Dijon Hospital
Kremlin Bicetre Hospital
Tours Hospital
Strasbourg Hospital
Montpellier Hospital
Bensancon Hospital
Clermont-Ferrand Hospital
Nantes Hospital
Angers Hospital
Trousseau Hospital
Bordeaux Hospital
Cochin Hospital
Nancy Hospital
Caen Hospital
Reims Hospital
Hospices Civils Lyon
Rennes Hospital
Hopital Europeen G Pompidou
Lille Hospital
Necker Hospital
Poitiers Hospital

nom_etablissement: CHU TOULOUSE

acronyme: ELPOT

titre: Evaluation de l'ELtrombopag en Peri-Opératoire lors de chirurgies et actes invasifs programmés chez les patients ayant une Thrombopénie constitutionnelle

discipline_principale: hématologie / vigilance et thérapeutique transfusionnelles

nom_porteur: SIE

prenom_porteur: Pierre


title: Sentinel Lymph Node After Neoadjuvant Chemotherapy in Breast Carcinoma

summary:
Sentinel lymph node dissection (SLND) after NAC, aimed to reduce the rate of unnecessary axillary lymphadenectomy, is not a standard of care in case of patient with previously involved node before NAC because of a too high false negative rate (FNR).

Clinical consequences of FNR of SLND after NAC are currently unknown. Consequently, contrary to adjuvant setting, a risk of SLND false negative case after NAC is not acceptable.

GANEA3 aims to evaluate the results of an innovative multiparametric strategy combining (1) an identification before chemotherapy of a lymph node involvement using a metal clip and then its analysis after treatment, (2) the analysis of sentinel lymph node (SLN) after NAC, and (3) analysis of biological parameters of breast tumor before and after NAC, to predict axillary status after NAC. This will identify patients with initial lymph node involvement who could benefit from SLN after NAC without additional axillary dissection with a very low FNR (≤1%).

The most "pathological" metastatic lymph node will be identified with a metal clip under ultrasound. They will then receive a NAC before breast and axillary surgery. An assessment of the NAC response at the breast and axillary will be performed by imagery. Then, all patients undergo the resection of the tagged axillary node with the metal clip, SLN detection and biopsy and a complementary axillary lymphadenectomy.

ReferenceCitation: Ditsch N, Rubio IT, Gasparri ML, de Boniface J, Kuehn T. Breast and axillary surgery in malignant breast disease: a review focused on literature of 2018 and 2019. Curr Opin Obstet Gynecol. 2020 Feb;32(1):91-99. doi: 10.1097/GCO.0000000000000593.

oa_host_type: repository

repository_institution: Augsburg University - OPUS - Augsburg University Publication Server

version: submittedVersion

unpaywall_oa_status: green

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Institut Cancerologie de l'Ouest

sponsor_collaborators:
Institut Cancerologie de l'Ouest
Direction Générale de l'Offre de Soins

location_facility:
Institut Bergonié
Centre Léon Bérard
CHP St GREGOIRE
Institut de Cancérlogie de Lorraine
Oscar Lambret
Institut de Cancérologie de Montpellier
Centre Jean Godinot
ICO - Site ANGERS
Céline RENAUDEAU
IUCT-O
Centre Georges Francoise Leclerc
CHU Brest
Hôpital St JOSEPH
Anne-Sophie Georges BATS
CURIE
APHP - Pitié Salpétrière
Institut Paoli Calmettes
Centre Jean Perrin

nom_etablissement: ICO - SITE PAUL PAPIN

type_etablissement: CLCC

titre: Ganglion sentinelle Après chimiothérapie NEoAdjuvante dans le cancer du sein - GANEA 3

nom_porteur: CLASSE

prenom_porteur: Jean-Marc


title: Randomized Comparative Prospective Multicentre Phase II Trial Evaluating Clinical Impact of Interruption VS Maintenance of AI in Patients With Locally Advanced/ Metastatic LGESS

acronym: BFR-ESS

summary: The primary objective is to compare the progression-free survival (PFS) between aromatase inhibitors interruption and aromatase inhibitors maintenance strategies in patients with a locally advanced or metastatic Low Grade Endometrial Stromal Sarcoma (LGESS).

lead_sponsor: Centre Leon Berard

location_facility:
Insitut Bergonié
Centre Léon Bérard
CHU Tours
Institut de Cancérologie de Montpellier
Insitut Curie
Centre Oscar Lambret
Institut Gustave Roussy
CHUSE
Hopital Pitié Salpétrière
Centre Jean Perrin
CHU Dupuytren
Institut Paoli Calmette
AP-HP Hopîtal Cochin
Centre Antoine Lacassagne
Hopital Privé de la Loire
Centre François Baclesse
ICO Centre René Gauducheau
Hopital La Timone
CHU Besançon
Institut Godinot
Centre Henri Becquerel