acronym: PERNETTA

title: A Randomized Phase II Trial of Pertuzumab in Combination With Trastuzumab With or Without Chemotherapy, Both Followed by T-DM1 in Case of Progression, in Patients With HER2-positive Metastatic Breast Cancer

lead_sponsor: Swiss Group for Clinical Cancer Research

location_country: Germany France Switzerland Netherlands

location_facility: Fondation Hopital Ambroise Pare - Hopital Europeen

location_facility: Centre Hospitalier Universitaire Vaudois CHUV

location_facility: Antoni van Leeuwenhoek / Slotervaart hospital

location_facility: Leiden_Leids Universitair Medisch Centrum (LUMC)

location_facility: Centre Hospitalier - Site Hopital du Scorff

location_facility: Hopitaux Universitaire de Strasbourg - Hopital Civil

location_facility: Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli

location_facility: Kantonsspital Frauenfeld / Brustzentrum Thurgau

location_facility: Zentrum fuer Tumordiagnostik und Praevention

location_facility: Institut Regional du Cancer Montpellier Val d'Aurelle

location_facility: Centre Hospitalier de Perpignan - Hopital Saint Jean

location_facility: Hopital Michallon - Centre Hospitalier Universitaire de Grenoble

summary: In HER2-positive metastatic breast cancer, trastuzumab based treatment is the standard of care as long as there are no contraindications to trastuzumab. Frequently, trastuzumab is being combined with taxanes in the first-line setting. However, since therapy with trastuzumab is active even in the absence of chemotherapy in HER2-positive MBC, the optimal treatment strategy either in combination or in sequence with chemotherapy is still under debate. This randomized phase II trial is studying a new strategy for the treatment of metastatic breast cancer with HER2-positive. First-line treatment consists of trastuzumab and pertuzumab, a treatment without chemotherapy. In case of disease progression, chemotherapy with T-DM1 is then performed as second-line treatment. Third-line and further line therapies are performed according to the physician's discretion. If this new therapeutic strategy is as effective and better tolerated than the conventional strategy, this would mean a serious breakthrough in the treatment of HER2-positive metastatic breast cancer.


status: Terminated

primary_purpose: Treatment

acronym: EXTEND

intervention_type: Drug

title: A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301

study_completion_date_type: Actual

lead_sponsor: Biogen

type: EudraCT Number

source: euctr

study_start_date_type: Actual

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Gold R, Stefoski D, Selmaj K, Havrdova E, Hurst C, Holman J, Tornesi B, Akella S, McCroskery P. Pregnancy Experience: Nonclinical Studies and Pregnancy Outcomes in the Daclizumab Clinical Study Program. Neurol Ther. 2016 Dec;5(2):169-182. Epub 2016 Jul 13.

enrollment_type: Actual

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Czechia
Poland
Russian Federation
Australia
Argentina
India
Israel
Mexico
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Moldova, Republic of
Denmark
Greece
Georgia
Ireland
France

summary:
The primary objective of the study is to assess the safety and tolerability of long-term treatment with BIIB019 (Daclizumab High Yield Process; DAC HYP) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS) who completed Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318).

Secondary objectives of this study in this study population are as follows:

To describe MS-related outcomes, including MS relapse, disability progression, MS lesion formation, and participant-reported impact of MS, following long-term treatment with DAC HYP To assess the long-term immunogenicity of DAC HYP administered by prefilled syringe (PFS) To assess the safety, tolerability, and efficacy of switching to DAC HYP in participants previously on long-term treatment with interferon β-1a (Avonex) in Study 205MS301(NCT01064401).

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas

acronym: Yosemite

summary:
The primary objective of this study is to evaluate the effect of the addition of idelalisib to rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL).

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).

design_allocation: Randomized

ipd_sharing: Yes

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

lead_sponsor: Gilead Sciences

location_country:
Poland
Taiwan
Portugal
Spain
Italy
Russian Federation
Australia
United Kingdom
Sweden
Hungary
Korea, Republic of
United States
France
Israel
Singapore
Romania
Japan
Germany
Czechia

location_facility: Hadassah Medical Organization, Ein Kerem

location_facility: Kobe City Medical Center General Hospital

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Gemeinschaftspraxis Dres. Söling Und Siehl

location_facility: Saint Petersburg I.P. Pavlov State Medical University

location_facility: Florida Cancer Specialists and Research Institute

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Semashko

location_facility: Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurskim

location_facility: Signal Point Clinical Research Center, LLC

location_facility: Hospital Geral de Santo António do Centro Hospitalar do Porto

location_facility: Haematology and Oncology Clinics of Australia at Chermside

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Center for Cancer and Blood Disorders, PC

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH

location_facility: Debreceni Egyetem Orvos-és Egészségtudományi Centrum

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

location_facility: Froedtert Hospital and Medical College of Wisconsin

location_facility: FSI "V.A. Almazov Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies"

location_facility: Centre Hospitalier Régional Universitaire de Lille, Hôpital Claude Huriez

location_facility: Azienda Ospedaliero Universitaria (AOU) "Maggiore della Carita" di Novara

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Centro di Riferimento Oncologico di Aviano


title: A Multicentre, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GFT505 Once Daily on Steatohepatitis in Patients With Non-Alcoholic Steatohepatitis (NASH).

summary:
Abdominal obesity and type-2 Diabetes are associated with chronic liver disorders resulting from the accumulation of fat in the liver (steatosis), which may progress towards hepatitis and possibly lead to cirrhosis and liver cancer. NAFLD (Non Alcoholic Fatty Liver Disease) is considered as the most common form of chronic liver disease in adults in the United States, Australia, Asia and Europe. In the USA, the estimated prevalence of NAFLD is 20-30% of the adult population.

Non-alcoholic Steatohepatitis (NASH) is a progressing form of NAFLD, which corresponds to hepatic steatosis associated with inflammation and liver cell injury upon microscopic examination of a liver biopsy. This condition may lead to advanced fibrosis and cirrhosis and deserves serious medical management. Up to now, there is no effective drug which has clearly demonstrated therapeutic efficacy which may help lifestyle and dietary recommendations in the resolution of NASH.

In this context, GENFIT is developing a new liver targeted drug candidate, GFT505, for the treatment of NASH and the reduction of multiple cardiometabolic risk factors associated with the metabolic syndrome and type 2 Diabetes.

This phase IIb study will evaluate the efficacy and safety of GFT505 80mg and 120mg once daily for 52 weeks on the reversal of NASH without worsening of fibrosis, based on liver biopsy assessments.

status: Completed

ReferenceCitation: Ratziu V, Harrison SA, Francque S, Bedossa P, Lehert P, Serfaty L, Romero-Gomez M, Boursier J, Abdelmalek M, Caldwell S, Drenth J, Anstee QM, Hum D, Hanf R, Roudot A, Megnien S, Staels B, Sanyal A; GOLDEN-505 Investigator Study Group. Elafibranor, an Agonist of the Peroxisome Proliferator-Activated Receptor-α and -δ, Induces Resolution of Nonalcoholic Steatohepatitis Without Fibrosis Worsening. Gastroenterology. 2016 May;150(5):1147-1159.e5. doi: 10.1053/j.gastro.2016.01.038. Epub 2016 Feb 11. Erratum in: Gastroenterology. 2017 Jun;152(8):2084.

lead_sponsor: Genfit

location_country:
Romania
Spain
Italy
United Kingdom
Netherlands
United States
France
Belgium
Germany

location_facility:
Site 701
Site 911
Site 108
Site 909
Site 504
Site 808
Site 507
Site 113
Site 104
Site 921
Site 603
Site 102
Site 930
Site 112
Site 601
Site 602
Site 205
Site 912
Site 801
Site 103
Site 803
Site 931
Site 404
Site 107
Site 106
Site 802
Site 902
Site 903
Site 706
Site 913
Site 703
Site 923
Site 405
Site 503
Site 302
Site 705
Site 101
Site 901
Site 501
Site 920
Site 906
Site 916
Site 917
Site 303
Site 908
Site 927
Site 202
Site 924
Site 201
Site 109
Site 707
Site 919
Site 204
Site 114
Site 203
Site 111

status_simplified: Completed


status: Active, not recruiting

title: Multicenter Phase III Randomized Study With Second Line Chemotherapy Plus or Minus Bevacizumab in Patients With Platinum Sensitive Epithelial Ovarian Cancer Recurrence After a Bevacizumab/Chemotherapy First Line

study_completion_date_type: Anticipated

lead_sponsor: National Cancer Institute, Naples

type: Other Identifier

ReferenceCitation: Pignata S, Lorusso D, Joly F, Gallo C, Colombo N, Sessa C, Bamias A, Salutari V, Selle F, Frezzini S, De Giorgi U, Pautier P, Bologna A, Orditura M, Dubot C, Gadducci A, Mammoliti S, Ray-Coquard I, Zafarana E, Breda E, Favier L, Ardizzoia A, Cinieri S, Largillier R, Sambataro D, Guardiola E, Lauria R, Pisano C, Raspagliesi F, Scambia G, Daniele G, Perrone F; MITO16b/MANGO-OV2/ENGOT-ov17 Investigators. Carboplatin-based doublet plus bevacizumab beyond progression versus carboplatin-based doublet alone in patients with platinum-sensitive ovarian cancer: a randomised, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):267-276. doi: 10.1016/S1470-2045(20)30637-9.

ReferenceCitation: Arend R, Westin SN, Coleman RL. Decision analysis for secondline maintenance treatment of platinum sensitive recurrent ovarian cancer: a review. Int J Gynecol Cancer. 2020 May;30(5):684-694. doi: 10.1136/ijgc-2019-001041. Epub 2020 Feb 19. Review.

location_country: Italy Greece Monaco Switzerland France

location_facility: Ospedale S. Maria delle Croci AUSL di Ravenna

location_facility: Centre de Radiothèrapie - Clinique Sainte-Anne

location_facility: Centre Hospitalier de la Région d'Annecy

location_facility: Ospedale S. Giovanni Calibita Fatebenefratelli

location_facility: Istituto Romagnolo per lo Studio e la Cura dei Tumori

location_facility: A.O. di Udine S. Maria della Misericordia

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Policlinico Universitario Gemelli Università Cattolica del Sacro Cuore

location_facility: Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico

location_facility: Zentrum fùr Onkologie/ Hamat. und Transf

location_facility: Fondazione del Piemonte per l'Oncologia IRCCS

location_facility: General Hospital of Thessaloniki Papageorgiou

location_facility: Centre Hospitalier Universitaire Dupuytren

location_facility: Hôpital Inter Armées de Begin (HIA Begin),

summary:
Bevacizumab has been found to prolong progression free survival in first line, and more recently, in second line treatment for platinum sensitive ovarian cancer patients who had not received prior treatment with bevacizumab.

Recently reported data suggest that patients with colon cancer who receive bevacizumab in more than one line of therapy (beyond progression) have better results. In ovarian cancer, the role of bevacizumab administered in both first and second-line therapies needs to be defined.

This study aims to evaluate whether administering bevacizumab in combination with chemotherapy in second-line therapy to patients with recurrent ovarian cancer who have received first-line bevacizumab will be more effective than chemotherapy alone.

status_simplified: Ongoing


title: 3% Hypertonic Saline to Reduce Hospitalization Rate in Acute Viral Bronchiolitis: a Randomized Double Blind Clinical Trial

acronym: GUERANDE

summary: The purpose of this study is to determine whether nebulized hypertonic saline solution reduces the admission rate 48 hours after initial treatment in the emergency department, when compared to normal saline solution (control).

ReferenceCitation: Angoulvant F, Bellêttre X, Milcent K, Teglas JP, Claudet I, Le Guen CG, de Pontual L, Minodier P, Dubos F, Brouard J, Soussan-Banini V, Degas-Bussiere V, Gatin A, Schweitzer C, Epaud R, Ryckewaert A, Cros P, Marot Y, Flahaut P, Saunier P, Babe P, Patteau G, Delebarre M, Titomanlio L, Vrignaud B, Trieu TV, Tahir A, Regnard D, Micheau P, Charara O, Henry S, Ploin D, Panjo H, Vabret A, Bouyer J, Gajdos V; Efficacy of 3% Hypertonic Saline in Acute Viral Bronchiolitis (GUERANDE) Study Group. Effect of Nebulized Hypertonic Saline Treatment in Emergency Departments on the Hospitalization Rate for Acute Bronchiolitis: A Randomized Clinical Trial. JAMA Pediatr. 2017 Aug 7;171(8):e171333. doi: 10.1001/jamapediatrics.2017.1333. Epub 2017 Aug 7.

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Centre Hospitalier intercommunal de Créteil

lead_sponsor_type: academique


title: Measurement of the Changes in Acceptability of Hepatitis B Immunization Among General Practitioners and Open-care Paediatricians

acronym: PRALINE

summary: The present study is conducted in order to assess the acceptability of Hepatitis B vaccination in French general practitioners and peadiatricians before and after reimbursement of the paediatric vaccine InfanrixHexa. Two data measurement time points are planned, first before reimbursement and after reimbursement.

study_type: Observational

time_perspective: Cross-Sectional

lead_sponsor: GlaxoSmithKline

intervention_type: Other


title: Micafungin Versus Placebo in the Nosocomial Sepsis in Patients Multi-colonized With Candida, Randomized Controlled Trial

acronym: EMPIRICUS

summary: Invasive Candida infections are burdened with a high mortality rate and is very common in intensive care units. This study aims to evaluate the efficacy of empirical treatment with micafungin in adult patients with suspected invasive candidiasis.

ReferenceCitation: Timsit JF, Azoulay E, Schwebel C, Charles PE, Cornet M, Souweine B, Klouche K, Jaber S, Trouillet JL, Bruneel F, Argaud L, Cousson J, Meziani F, Gruson D, Paris A, Darmon M, Garrouste-Orgeas M, Navellou JC, Foucrier A, Allaouchiche B, Das V, Gangneux JP, Ruckly S, Maubon D, Jullien V, Wolff M; EMPIRICUS Trial Group. Empirical Micafungin Treatment and Survival Without Invasive Fungal Infection in Adults With ICU-Acquired Sepsis, Candida Colonization, and Multiple Organ Failure: The EMPIRICUS Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1555-1564. doi: 10.1001/jama.2016.14655.

ReferenceCitation: Timsit JF, Azoulay E, Cornet M, Gangneux JP, Jullien V, Vésin A, Schir E, Wolff M. EMPIRICUS micafungin versus placebo during nosocomial sepsis in Candida multi-colonized ICU patients with multiple organ failures: study protocol for a randomized controlled trial. Trials. 2013 Nov 21;14:399. doi: 10.1186/1745-6215-14-399.

lead_sponsor: University Hospital, Grenoble

location_facility: University Hospital of La Pitié Salpetrière


acronym: Ultimate

title: Phase III Study Comparing the Efficacy of Paclitaxel-bevacizumab With Docetaxel in 2nd or 3rd Line of Treatment of Non Squamous Non Small Cells Lung Cancer

lead_sponsor: Intergroupe Francophone de Cancerologie Thoracique

ReferenceCitation: Cortot AB, Audigier-Valette C, Molinier O, Le Moulec S, Barlesi F, Zalcman G, Dumont P, Pouessel D, Poulet C, Fontaine-Delaruelle C, Hiret S, Dixmier A, Renault PA, Becht C, Raffy O, Dayen C, Mazieres J, Pichon E, Langlais A, Morin F, Moro-Sibilot D, Besse B. Weekly paclitaxel plus bevacizumab versus docetaxel as second- or third-line treatment in advanced non-squamous non-small-cell lung cancer: Results of the IFCT-1103 ULTIMATE study. Eur J Cancer. 2020 May;131:27-36. doi: 10.1016/j.ejca.2020.02.022. Epub 2020 Apr 8.

enrollment_type: Anticipated

location_facility: Lyon - Hôpital Louis Pradel (Pneumologie)

summary:
The study objective is to evaluate the efficacy of paclitaxel-bevacizumab comparing to docetaxel.

Docetaxel is a standard treatment of 2nd or 3rd line in lung cancer. It was validated by numerous clinical trials but sometimes toxicities are difficult to manage.

Bevacizumab is an antiangiogenic treatment which was validated by numerous clinical trials in association with platinum in first ligne. Different clinical and preclinical data suggest that there could exist a synergy between paclitaxel and bevacizumab. This association is already used in metastatic breast cancer, it permits almost to double the response rate and progression free survival. In lung cancer, the association was evaluated by two retrospective studies which demonstrated a benefit with a favourable safety profile.


title: Addition of Suberoylanilide Hydroxamic Acid (Vorinostat) to Azacitidine in Patients With Higher Risk Myelodysplastic Syndromes (MDS): a Phase II add-on Study in Patients With Azacitidine Failure.

acronym: GFM-AZA-VOR

summary:
Azacytidine (AZA) is the current standard of care for frontline patient treated with high-risk MDS and is clinically active in all type of MDS, however, 50% of the patients will never respond. Vorinostat is an orally available HDAC inhibitor with clinical activity in MDS and proven in vitro synergy with AZA. Patient treated upfront with a combination of this agents have shown more responses based on phase I/II data. In the present study, we will use the combination of these two drugs to try to create a synergetic effect and generate a response for patients who experienced treatment failure after AZA.

All eligible patients will be treated with Azacitidine and oral vorinostat for 6 cycles of 28 days. Study Design

ipd_sharing: No

lead_sponsor: Groupe Francophone des Myelodysplasies

location_facility: Hôpital PURPAN, Service d'Hématologie Clinique

location_facility: Hopital Saint Louis - AP-HP, Hematology Dpt


type: Registry Identifier

title: Cohort Study of Prospective Validation of Predictive Factors and Biological Imaging of Response to Bevacizumab (AVASTIN ®) in Combination With Weekly Paclitaxel Chemotherapy in First Line Treatment Patients With Metastatic Breast Cancer

acronym: COMET

summary:
Bevacizumab plus chemotherapy improves response rates and prolongs PFS when used as first- and second-line therapy for advanced breast cancer. However, bevacizumab has not improved OS in the individual studies currently reported. In Europe, EMA has maintained its indication associated with weekly paclitaxel in first line metastatic breast cancer and more recently with capecitabine based on RIBBON 1 trial's results.

The identification of patient subsets that receive the most clinical benefit would enable more specific treatment administration of bevacizumab and allow patients unlikely to benefit the opportunity to seek other treatment modalities. Unfortunately, despite efforts to identify patient subsets with a differential benefit from bevacizumab, no validated biomarkers have been defined.

The Avastin cohort is a unique opportunity to investigate various biological and imaging parameters which could be related to clinical benefit of the combination of bevacizumab and weekly paclitaxel in first line metastatic breast cancer in a homogeneously treated population in French cancer centers. This trial will gather the expertise of several translational research platforms of different cancer centers from the UNICANCER consortium.

time_perspective: Prospective

ReferenceType: result

ReferenceCitation: Bortolini Silveira A, Bidard FC, Tanguy ML, Girard E, Trédan O, Dubot C, Jacot W, Goncalves A, Debled M, Levy C, Ferrero JM, Jouannaud C, Rios M, Mouret-Reynier MA, Dalenc F, Hego C, Rampanou A, Albaud B, Baulande S, Berger F, Lemonnier J, Renault S, Desmoulins I, Proudhon C, Pierga JY. Multimodal liquid biopsy for early monitoring and outcome prediction of chemotherapy in metastatic breast cancer. NPJ Breast Cancer. 2021 Sep 9;7(1):115. doi: 10.1038/s41523-021-00319-4.

ReferenceCitation: Gal J, Milano G, Brest P, Ebran N, Gilhodes J, Llorca L, Dubot C, Romieu G, Desmoulins I, Brain E, Goncalves A, Ferrero JM, Cottu PH, Debled M, Tredan O, Chamorey E, Merlano MC, Lemonnier J, Etienne-Grimaldi MC, Pierga JY. VEGF-Related Germinal Polymorphisms May Identify a Subgroup of Breast Cancer Patients with Favorable Outcome under Bevacizumab-Based Therapy-A Message from COMET, a French Unicancer Multicentric Study. Pharmaceuticals (Basel). 2020 Nov 23;13(11). pii: E414. doi: 10.3390/ph13110414.

ReferenceCitation: Vasseur A, Cabel L, Tredan O, Chevrier M, Dubot C, Lorgis V, Jacot W, Goncalves A, Debled M, Levy C, Ferrero JM, Jouannaud C, Luporsi E, Mouret-Reynier MA, Dalenc F, Lemonnier J, Savignoni A, Tanguy ML, Bidard FC, Pierga JY. Prognostic value of CEC count in HER2-negative metastatic breast cancer patients treated with bevacizumab and chemotherapy: a prospective validation study (UCBG COMET). Angiogenesis. 2020 May;23(2):193-202. doi: 10.1007/s10456-019-09697-7. Epub 2019 Nov 26.

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.

lead_sponsor: UNICANCER

location_facility:
Centre Alexis Vautrin
Institut Claudius Regaud
Institut Bergonie
Institut Jean Godinot
Centre Hospitalier
Centre Catherine de Sienne
Centre Paul Strauss
Institut Paoli Calmettes
Centre Jean Perrin
Centre Antoine Lacassagne
Hôpital Européen
Centre Francois Baclesse
CHU Grenoble
Institut Gustave Roussy
Centre Leon Berard
Institut Curie
Centre Georges Francois Leclerc
Centre Val d'Aurelle


title: A Multicenter Open Label Phase II Study of Pomalidomide and Dexamethasone in Progressive Relapsed or Refractory Multiple Myeloma Patients With Deletion 17p or Translocation (4;14) Adverse Karyotypic Abnormalities-IFM2010-02

lead_sponsor: University Hospital, Lille

ReferenceCitation: Leleu X, Karlin L, Macro M, Hulin C, Garderet L, Roussel M, Arnulf B, Pegourie B, Kolb B, Stoppa AM, Brechiniac S, Marit G, Thielemans B, Onraed B, Mathiot C, Banos A, Lacotte L, Tiab M, Dib M, Fuzibet JG, Petillon MO, Rodon P, Wetterwald M, Royer B, Legros L, Benboubker L, Decaux O, Escoffre-Barbe M, Caillot D, Fermand JP, Moreau P, Attal M, Avet-Loiseau H, Facon T; Intergroupe Francophone du Myélome (IFM). Pomalidomide plus low-dose dexamethasone in multiple myeloma with deletion 17p and/or translocation (4;14): IFM 2010-02 trial results. Blood. 2015 Feb 26;125(9):1411-7. doi: 10.1182/blood-2014-11-612069. Epub 2015 Jan 9.

location_facility: Centre hospitalier départemental La Roche sur Yon

summary: The purpose of this study is to determine the efficacy and toxicity profile of Pomalidomide and Dexamethasone in relapsed or refractory Multiple Myeloma patients with deletion 17p or translocation (4;14)


title: Relevance of Imiquimod as Neo-adjuvant Treatment to Reduce Excision Size and the Risk of Intralesional Excision in Lentigo Malignant of the Face

acronym: ImiReduc

summary:
Lentigo malignant (LM) is an intraepidermal melanocytic proliferation occurring on photoexposed skin. In our project, this term applies both to Dubreuilh's melanosis and to Dubreuilh's intraepidermal melanoma. It consequently excludes invasive melanoma. Although surgery is the treatment of choice, it remains without consensus on the margins (5 mm or 10 mm) excision for a localized tumor on the face.

Several studies have shown that imiquimod, activating local immunity by interferon production, induced LM or MLM regression and could also decrease the frequency of relapses.

The principal aim of our project is to study the effect of imiquimod versus placebo in pre-operative neoadjuvant treatment aimed at reducing both surgical margins, as from the first surgical procedure, and the frequency of short and medium term recurrence of LM. Furthermore, the improvement in patient quality of life could also be significant.

status: Unknown status

lead_sponsor: Nantes University Hospital

location_facility: Centre Hospitalier Universitaire de Nantes


title: Randomized Trial to Evaluate the Medico-economic Interest of Taking Into Account Circulating Tumor Cells (CTC) to Determine the Kind of First Line Treatment for Metastatic, Hormone-receptors Positive, Breast Cancers.

summary: The STIC CTC study is a randomized trial to evaluate the medico-economic interest of taking into account circulating tumor cells (CTC) to determine the kind of first line treatment for metastatic, hormone-receptors positive, breast cancers. In the standard arm, the kind of treatment will be decided by clinicians, taking into account the criteria usually used in this setting. In the CTC arm, the type of treatment will be decided by CTC count: hormone-therapy if <5CTC/7.5mll (CellSearch technique) or chemotherapy if =5. The main medical objective is to demonstrate the non-inferiority of the CTC-based strategy for the progression-free survival: 994 patients are needed, and will be accrued in French cancer centers. Secondary clinical objectives are to compare toxicity, quality of life and overall survival between the two arms. The medico-economic study will compare cost per progression-free life years gained of the two strategies. The financial impact of centralized (one platform) vs decentralized (several platforms) CTC testing will be evaluated.

ReferenceCitation: Bidard FC, Jacot W, Kiavue N, Dureau S, Kadi A, Brain E, Bachelot T, Bourgeois H, Gonçalves A, Ladoire S, Naman H, Dalenc F, Gligorov J, Espié M, Emile G, Ferrero JM, Loirat D, Frank S, Cabel L, Diéras V, Cayrefourcq L, Simondi C, Berger F, Alix-Panabières C, Pierga JY. Efficacy of Circulating Tumor Cell Count-Driven vs Clinician-Driven First-line Therapy Choice in Hormone Receptor-Positive, ERBB2-Negative Metastatic Breast Cancer: The STIC CTC Randomized Clinical Trial. JAMA Oncol. 2021 Jan 1;7(1):34-41. doi: 10.1001/jamaoncol.2020.5660.

lead_sponsor: Institut Curie

location_facility: Institut régional du Cancer de Montpellier

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

intervention_type: Biological


title: Phase Ib / II Trial Evaluating the Association Myocet ® - Carboplatine in Patients Having a Cancer of the Ovary in Relapse, Sensitive to the Platinum

acronym: MYCA

summary: The purpose of this study is to determine the efficacy and the safety of the association of carboplatine and liposomal doxorubicin in patient with ovarian cancer in relapse, sensitive to platin.

ReferenceCitation: Romeo C, Joly F, Ray-Coquard I, El Kouri C, Mercier-Blas A, Berton-Rigaud D, Kalbacher E, Cojocarasu O, Fabbro M, Cretin J, Zannetti A, Abadie-Lacourtoisie S, Mollon D, Hardy-Bessard AC, Provansal M, Blot E, Delbaldo C, Lesoin A, Freyer G, You B. Non-pegylated liposomal doxorubicin (NPLD, Myocet®) + carboplatin in patients with platinum sensitive ovarian cancers: A ARCAGY-GINECO phase IB-II trial. Gynecol Oncol. 2019 Jan;152(1):68-75. doi: 10.1016/j.ygyno.2018.10.043. Epub 2018 Nov 14.

lead_sponsor: ARCAGY/ GINECO GROUP

location_facility: Centre Hospitalier de la Région d'Annecy

location_facility: Centre hospitalier privé de Saint Grégoire

location_facility: Centre de Radiothérapie - Clinique Sainte-Anne

location_facility: Hôpital Morvan - Centre Hospitalier Universitaire

location_facility: Centre Hospitalier General de Valenciennes

location_facility: Centre Hospitalier Départemental Les Oudairies


title: SHOview Observational Study. Controlled Ovarian Stimulation by HP-hMG for IVF / ICSI Cycles: Study on Ovarian Hyper Stimulation Syndrome in a Cohort of Women From 18 to 36 Years Old.

acronym: SHOview

summary: Ovarian hyper stimulation syndrome (OHSS) is a potentially serious complication of ovarian stimulation in IVF (In Vitro Fertilisation). The main objective of this study is to describe the incidence of moderate or severe forms of OHSS in women between 18 and 36 years of age treated with HP-hMG.

ReferenceCitation: Barrière P, Dewailly D, Duhamel A, Gayet V. [Ovarian hyperstimulation syndrome after stimulation with highly purified hMGfor in vitro fertilization: Observational study SHOview]. Gynecol Obstet Fertil Senol. 2017 May;45(5):283-290. doi: 10.1016/j.gofs.2017.03.004. Epub 2017 Apr 29. French.

lead_sponsor: Ferring Pharmaceuticals

location_facility: Cabinet Médical Lille avenue de Dunkerque

location_facility: Groupe Hospitalier du Havre - Hôpital Jacques Monod

location_facility: Cabinet Mirabeau Roy René (there may be other sites in this country)


title: Impact of Either Audit and Feedback Only or Audit and Feedback Associated to Cooperative Work Meetings Between Hospital Geriatricians and Nursing Home Staff on Quality Indicators and Health Care Practices in Nursing Homes.

acronym: IQUARE

summary:
Introduction: Efficacy of audit and feedback interventions on nursing home (NH)quality indicators is not well-established.

The main objective: The main purpose of the IQUARE study was to examine the impact of two types of audit and feedback interventions on NH quality indicators and on residents dependence levels in a 18-month follow-up.

Study hypothesis: We hypothesised that audit and feedback associated to educational and professional supportive interventions are more efficacy in improving NH quality indicators than audit and feedback only.

Secondary objectives: Investigate the impact of the interventions on

Residents:

Functional decline rate
Drug prescriptions (quantity and quality)
Prevalence of adverse health outcomes (e.g., falls)

NHs:

Planning and implementation of therapeutic measures

design_allocation: Non-Randomized

primary_purpose: Health Services Research

ReferenceCitation: Dubucs X, de Souto Barreto P, Rolland Y. Organizational and environmental factors associated with transfers of nursing home residents to emergency departments. Eur Geriatr Med. 2018 Jun;9(3):339-346. doi: 10.1007/s41999-018-0059-x. Epub 2018 May 8.

ReferenceCitation: Cool C, Cestac P, McCambridge C, Rouch L, de Souto Barreto P, Rolland Y, Lapeyre-Mestre M. Reducing potentially inappropriate drug prescribing in nursing home residents: effectiveness of a geriatric intervention. Br J Clin Pharmacol. 2018 Jul;84(7):1598-1610. doi: 10.1111/bcp.13598. Epub 2018 May 14.

ReferenceCitation: Laffon de Mazières C, Lapeyre-Mestre M, Vellas B, de Souto Barreto P, Rolland Y. Organizational Factors Associated With Inappropriate Neuroleptic Drug Prescribing in Nursing Homes: A Multilevel Approach. J Am Med Dir Assoc. 2015 Jul 1;16(7):590-7. doi: 10.1016/j.jamda.2015.01.092. Epub 2015 Mar 10.

lead_sponsor: Agence Régionale de la Santé - Midi Pyrénées

location_facility: EHPAD Résidence Mutualiste La Pyrénéenne

location_facility: EHPAD du Centre Hospitalier Des Deux Rives

location_facility: Centre hospitalier du Pays d´Olmes - Laroques d´Olmes

location_facility: Centre hospitalier du Pays d´Olmes - Résidence du Touyre

location_facility: EHPAD Hermitage et Terrasses de Rabastens

location_facility: EHPAD Villégiale Saint Jacques CHIC - CASTRES/MAZAMET

intervention_type: Behavioral


title: Impact on Mortality of the Timing of Renal Replacement Therapy in Patients With Severe Acute Kidney Injury in Septic Shock: the IDEAL-ICU Study (Initiation of Dialysis Early Versus Delayed in the Intensive Care Unit): Study Protocol for a Randomized Controlled Trial

acronym: IDEAL-ICU

summary: The purpose of this multicentric, randomized controlled trial is to assess whether the timing of renal replacement therapy initiation (early vs delayed) has an impact on mortality at 90 days in patients with severe acute kidney injury at the failure stage (according to RIFLE criteria) during the initial phase of septic shock.

primary_purpose: Other

ReferenceType: background

ReferenceCitation: Barbar SD, Binquet C, Monchi M, Bruyère R, Quenot JP. Impact on mortality of the timing of renal replacement therapy in patients with severe acute kidney injury in septic shock: the IDEAL-ICU study (initiation of dialysis early versus delayed in the intensive care unit): study protocol for a randomized controlled trial. Trials. 2014 Jul 7;15:270. doi: 10.1186/1745-6215-15-270.

ReferenceCitation: Barbar SD, Clere-Jehl R, Bourredjem A, Hernu R, Montini F, Bruyère R, Lebert C, Bohé J, Badie J, Eraldi JP, Rigaud JP, Levy B, Siami S, Louis G, Bouadma L, Constantin JM, Mercier E, Klouche K, du Cheyron D, Piton G, Annane D, Jaber S, van der Linden T, Blasco G, Mira JP, Schwebel C, Chimot L, Guiot P, Nay MA, Meziani F, Helms J, Roger C, Louart B, Trusson R, Dargent A, Binquet C, Quenot JP; IDEAL-ICU Trial Investigators and the CRICS TRIGGERSEP Network. Timing of Renal-Replacement Therapy in Patients with Acute Kidney Injury and Sepsis. N Engl J Med. 2018 Oct 11;379(15):1431-1442. doi: 10.1056/NEJMoa1803213.

lead_sponsor: Centre Hospitalier Universitaire Dijon

location_facility: Groupe Hospitalier de l'institut Catholique de LILLE

location_facility: CHU de Strasbourg - Nouvel hôpital civil

location_facility: Hôpital Raymond-Poincaré GARCHES (AP-HP)

intervention_type: Procedure


title: Everolimus as Treatment After Embolization or Chemoembolization for Liver Metastases From Digestive Endocrine Tumors

acronym: EVACEL

summary:
Determine wether 24 months treatment with everolimus prolongs progression free survival rate (based on a central assessment) after embolisation ou chemoembolisation for liver metastases.

H0 a 24 months progression free survival rate less than 35% is unacceptable
H1 a 24 months progression free survival rate greater than 35% would show that everolimus treatment is beneficial, the expected 24 months progression free survival rate being 50%

ReferenceCitation: Walter T, Lepage C, Coriat R, Barbier E, Cadiot G, Caroli-Bosc FX, Aparicio T, Bouhier-Leporrier K, Hentic-Dhome O, Gay F, Dupont-Gossart AC, Duluc M, Lepere C, Lecomte T, Smith D, Petorin C, Di-Fiore F, Ghiringhelli F, Legoux JL, Guimbaud R, Baudin E, Lombard-Bohas C, de Baère T; FFCD 1104 investigators/investigators. Everolimus after hepatic arterial embolisation therapy of metastases from gastrointestinal neuroendocrine tumours: The FFCD 1104-EVACEL-GTE phase II study. Eur J Cancer. 2019 Dec;123:92-100. doi: 10.1016/j.ejca.2019.09.021. Epub 2019 Oct 31.

lead_sponsor: Federation Francophone de Cancerologie Digestive

location_facility:
CHU - Hôpital François Mitterand
CHU La Timone
Hôpital Edouard Herriot
Centre GF Leclerc
Hôpital Côte de Nacre
Hôpital Saint André
CHU Cochin
Hôpital Européen Georges Pompidou
CHU
CHU - Hôtel Dieu
Hôpital Beaujon
Hôpital Robert Debré
Hôpital Trousseau
Institut Gustave Roussy
CHU - Estaing
CHR
Hôpital Avicenne
Hôpital Rangueil

intervention_type: Device


title: Phase II: First Line Treatment by FOLFIRINOX for Patients With a Rectum Cancer With Synchronous Non Resectable Metastasis

summary:
The FOLFIRINOX protocol seems a promising protocol as attack treatment of a rectum cancer, with an objective response rate of about 70 %. This phase II is to investigate if this systematic attack chemotherapy could control at the same time the rectal tumor and the synchronous metastasis without compromising secondarily the tumor or the metastasis resection or a radiochemotherapy administration.

The main objective of the trial is to investigate the tumoral control rate at 4 months, according to the RECIST criteria (version 1.1).

The secondary objectives are:

safety of the treament,
rate of local failure and local complication (occlusion, important bleedings, resistant pains with morphinic treatment, perforation),
survival without local failure (radiological or clinical progression of the rectal cancer or local complication),
rectal tumor response rate (CT scan, MRI and endocopy),
metastasis response rate,
disease free survival after complete resection (of primitive tumor and metastases),
progression free survival (local or distal),
overall survival, quality of life (QLQ-C30 + CR 29).

ReferenceCitation: Bachet JB, Lucidarme O, Levache CB, Barbier E, Raoul JL, Lecomte T, Desauw C, Brocard F, Pernot S, Breysacher G, Lagasse JP, Di Fiore F, Etienne PL, Dupuis OJM, Aleba A, Lepage C, Taieb J; for FFCD 1102 investigators. FOLFIRINOX as induction treatment in rectal cancer patients with synchronous metastases: Results of the FFCD 1102 phase II trial. Eur J Cancer. 2018 Nov;104:108-116. doi: 10.1016/j.ejca.2018.09.006. Epub 2018 Oct 18.

location_facility:
Clinique Victor Hugo
Clinique Armoricaine
CAC
CH Georges Menon
CHRU Trousseau
CHR - Gasto
Centre G.F. Leclerc
CH
CHU - Ht Lévêque
Avicennes
Ipc - Cac
CHU
Centre Cahterine de Sienne
Polyclinique le Languedoc
CH Le Foll
CHU d'Estaing
CH Robert Morlevat
CHD Vendée
Clinique Saint Jean du Languedoc
CHRU - Hôpital Huriez
Institut Bergonie
CHU La Timone
AP - HP - Pitié Salpêtrière
Colmar Ch
Polyclinique de l'Ormeau
Hôpitaux du Leman
Polyclinique
Polyclinique Côte Basque Sud
CH Layne


title: Research of Prognostic Factors Associated With Healing of Venous Leg Ulcers

summary: This study was undertaken to identify prospectively which clinical venous leg ulcer (VLU) characteristics known as possible prognostic markers, and which sociodemographic and psychologic factors associated with VLU are associated with complete healing at 24 weeks.

lead_sponsor: Centre Hospitalier Universitaire, Amiens

location_facility: Hôpital Saint Louis - Service de Dermatologie

location_facility: Centre Hospitalier de Valence - Dermatologie

location_facility: Hôpital Saint Vincent de Paul - Médecine interne et Gériatrie I

location_facility: Centre Hospitalier - Service de Médecine Interne

location_facility: Hôpital d'Instruction des Armées Desgenettes

location_facility: Cabinet de Dermatologie 43, rue Jean Lecanuet

location_facility: Centre Hospitalier Intercommunal Poissy Saint Germain

location_facility: Centre Hospitalo-Universitaire d'Amiens - Dermatologie

location_facility: Hôpital Claude Huriez - Clinique Dermatologique

location_facility: Hôpital Rothschild - Consultation de Dermatologie

location_facility: Hôpital C. Foix - Service de Gérontologie

location_facility: Hôpitaux Civils de Colmar - Service de Dermatologie

location_facility: Hôpital Charles NICOLLE - Service de Dermatologie

location_facility: Centre Hospitalier Laennec - Dermatologie

location_facility: Hôpital Broussais - Rééducation Vasculaire

location_facility: Hôpital Sainte Marguerite - Dermatologie

location_facility: Cabinet de Dermatologie 1,rue dembarrère


title: A Prospective Cohort Study Assessing the Efficacy and Safety of Tarceva in 2nd Line in Patients With Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)

summary: This observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in second line in patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after failure of first line platinum-based chemotherapy. Eligible patients will be followed for 12 months.

lead_sponsor: Hoffmann-La Roche


acronym: Dose Ranging, Switch Study of ISL and MK-8507 Once-Weekly

title: A Phase 2b, Randomized, Active-Controlled, Double-Blind, Dose-Ranging Clinical Study to Evaluate a Switch to Islatravir (ISL) and MK-8507 Once-Weekly in Adults With HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once-Daily

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
United States
Switzerland
France

location_facility: Chatham County Health Department ( Site 2707)

location_facility: Pitie Salpetriere University Hospital-Infectious Disease - Tropical Diseases ( Site 2306)

location_facility: Midway Immunology and Research ( Site 2713)

location_facility: Centre Hospitalier Regional du Orleans ( Site 2304)

location_facility: Texas Centers for Infectious Disease Associates P.A. ( Site 2709)

location_facility: Hopitaux Universitaires de Geneve HUG ( Site 2604)

location_facility: CHUV (centre hospitalier universitaire vaudois) ( Site 2605)

location_facility: DCOL Center for Clinical Research ( Site 2715)

location_facility: Saint Hope Foundation, Inc. ( Site 2716)

location_facility: Universitaetsspital Zuerich ( Site 2601)

location_facility: CHU de Toulouse - Hopital Purpan ( Site 2302)

location_facility: Infectious Disease Specialists Of Atlanta PC ( Site 2704)

location_facility: Triple O Research Institute, P.A. ( Site 2712)

location_facility: Inselspital Universitaetsspital Bern ( Site 2603)

summary: This is a randomized, controlled, double-blind, study to evaluate the safety and tolerability of islatravir (ISL) + MK-8507 based on review of the accumulated safety data, in adult participants with human immunodeficiency virus type 1 (HIV-1) who have been virologically suppressed for ≥6 months on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) once-daily.


title: Phase 2, Single-arm, Open-label Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations and Progressed On or After Applicable Targeted Therapy and Platinum Based Chemotherapy (TROPION-Lung05)

summary: This is a study of the efficacy, pharmacokinetics, and safety of DS-1062a in participants with advanced or metastatic non-small cell lung cancer (NSCLC) with known actionable genomic alterations.

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Taiwan
Spain
Italy
Netherlands
Hungary
Korea, Republic of
United States
France
Japan
Germany

location_facility: National Taiwan University Hospital NTUH

location_facility: Washington University School of Medicine

location_facility: Hospital General Universitario de Alicante

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Sarah Cannon Research Institute at Florida Cancer Center, South

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Sarah Cannon Research Institute at Florida Cancer Center, North

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Azienda Ospedaliero-Universitaria S. Orsola Malpighi

location_facility: Hospital Universitario Puerta de Hierro de Majadahonda

location_facility: Seoul National University Bundang Hospital

location_facility: Hopitaux Universitaire de Strasbourg- Nouvel Hopital Civil

location_facility: XCancer / Regional Cancer Care Associate (Astera)

location_facility: Centre Hospitalier Intercommunal Toulon La Seyne sur mer Hopital Sainte-Musse

location_facility: Azienda Ospedaliera Universitaria Policlinico-OVE

location_facility: Azienda Ospedaliera Arcispedale Santa Maria

location_facility: National Koranyi Institute for TB and Pulmonology

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Sarah Cannon Research Institute at Tennessee Oncology - Chattanooga

location_facility: University Hospitals Case Medical Center


title: Inappropriate Therapies and Home Monitoring® in Implantable Cardioverter Defibrillators (ICD)

acronym: THORN

summary:
The purpose of the THORN registry is to show the ability of Home-Monitoring® to early identify and manage the inappropriate diagnoses of ventricular arrhythmia in ICD patients (i.e. lead rupture, atrial arrhythmia, oversensing…) whatever the type of device (single, dual, or triple chamber).

The electromyograms (iEGMs) provided by Remote Patient Monitoring will help the physician to early detect inadequate arrhythmia detection (ID) that can be responsible for inappropriate therapies (IT), and to take preventive actions in order to reduce the burden of these inappropriate therapies.

THORN is an observational epidemiologic, prospective and multicenter registry. The primary objective is to measure the relative proportion of patients experiencing at least one inappropriate therapy during a fifteen months follow-up period. Moreover, THORN will assess the incidence, predictors, outcome and recurrence of inappropriate diagnoses in 1750 ICD patients.

ReferenceCitation: Perrin T, Boveda S, Defaye P, Rosier A, Sadoul N, Bordachar P, Klug D, Ritter P, Belhameche M, Babuty D, Mansourati J, Lazarus A, Deharo JC. Role of medical reaction in management of inappropriate ventricular arrhythmia diagnosis: the inappropriate Therapy and HOme monitoRiNg (THORN) registry. Europace. 2019 Apr 1;21(4):607-615. doi: 10.1093/europace/euy284.

lead_sponsor: Biotronik SE & Co. KG

location_facility:
Clinique Lafourcade
Clinique Saint Augustin
CH de Valenciennes
CH de DAX
CHU Clermont-Ferrand
CH de Pau
CH de Moulins
CHU Bordeaux
Hôpital Nord
Clinique de la Sauvegarde
CH d'Angoulême
Clinique Ambroise Paré
CH William-Morey
CHI de Montfermeil
CHU la Cavale Blanche
CHU G. & R. Laënnec
Hôpital Militaire
Clinique du Milénaire
CH de Troyes
Institut Jacques Cartier
CH de la Cote Basque
CHU la Mileterie
CH de Saint Brieuc
CHU de Montpellier
CH de Lagny sur Marne
Clinique Pasteur
CHRU Tours (Hôpital Trousseau)
Hôpital Cardiologique
CH Bretagne Atlantique
Centre Hospitalier Sud Francilien
Hôpital La Timone
CH St Luc St Joseph
CH d'Avignon
CH d'Aix en Provence
Clinique Saint Pierre
CHU Nîmes
Hôpital Albert Schweitzer
CH de Haguenau
CH de Rodez
CHG de Chateauroux
CH d'Angers
CH de Villefranche
CHU de St-Etienne
Chu Hôpital Charles Nicolle
CH de Périgueux
CH de Valence
CH Robert Boulin
Hôpital Font Pré
CHU de Dijon
Hôpital Georges Pompidou
CHU Albert Michalon
CHU (Hôpital Pontchaillou)
Clinique Saint Joseph
CHRU de Lille
CHU de Nancy


status: Recruiting

title: A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Navitoclax in Combination With Ruxolitinib Versus Best Available Therapy in Subjects With Relapsed/Refractory Myelofibrosis (TRANSFORM-2)

lead_sponsor: AbbVie

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
United States
Belgium
Japan
South Africa
Czechia
Poland
Austria
Australia
Russian Federation
Puerto Rico
Israel
Turkey
Sweden
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Taiwan
Greece
New Zealand
Korea, Republic of
France

location_facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 221346

location_facility: Inselspital, Universitätsspital Bern /ID# 223439

location_facility: CHU Bordeaux - Hopital Haut Leveque /ID# 222696

location_facility: SP ZOZ Szpital Uniwersytecki w Krakowie /ID# 221160

location_facility: CHU NIMES - Hopital Caremeau /ID# 219128

location_facility: Northwest Oncology & Hematology - Elk Grove Village /ID# 222818

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 221124

location_facility: Juntendo University Shizuoka Hospital /ID# 221780

location_facility: Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 221115

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 218980

location_facility: Hospital Universitario A Coruna - CHUAC /ID# 224617

location_facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 220914

location_facility: Hospital del Centro Comprensivo de Cancer de la UPR /ID# 223281

location_facility: General Hospital of Thessaloniki George Papanikolaou /ID# 221463

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 219087

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 219061

location_facility: Tel Aviv Sourasky Medical Center /ID# 219135

location_facility: Kobe City Medical Center General Hospital /ID# 221156

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 221335

location_facility: Klinicki bolnicki centar Zagreb /ID# 230798

location_facility: UMHAT Dr Georgi Stranski EAD /ID# 231650

location_facility: Weill Cornell Medical College /ID# 220866

location_facility: Assuta Ashdod Medical Center /ID# 225281

location_facility: The Chaim Sheba Medical Center /ID# 219136

location_facility: Kanazawa University Hospital /ID# 223028

location_facility: Moores Cancer Center at UC San Diego /ID# 219009

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 233727

location_facility: Hospital of the University of Pennsylvania /ID# 219001

location_facility: Niigata University Medical & Dental Hospital /ID# 223034

location_facility: Tulane Medical Center - New Orleans /ID# 222940

location_facility: Virginia Cancer Specialists - Fairfax /ID# 223016

location_facility: Sjællands Universitetshospital /ID# 224456

location_facility: Border Medical Oncology Research Unit Albury Wodonga Regional Cancer Centre /ID# 223848

location_facility: American Oncology Partners of Maryland, PA /ID# 222836

location_facility: Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 221150

location_facility: Moscow State budget healthcare /ID# 221116

location_facility: Shonan Kamakura General Hospital /ID# 223030

location_facility: Klinicki bolnicki centar Split /ID# 230800

location_facility: Azienda ULSS 8 Berica/Ospedale San Bortolo di Vicenza /ID# 221079

location_facility: Gachon University Gil Medical Center /ID# 220972

location_facility: Ondokuz mayis University Facul /ID# 224567

location_facility: Medizinische Universitaet Wien /ID# 220911

location_facility: ASST Monza/Ospedale San Gerardo /ID# 225113

location_facility: Azienda Ospedaliero Universitaria Careggi /ID# 219090

location_facility: McGill University Health Center Research Institute /ID# 222614

location_facility: University Hospitals Birmingham NHS Foundation Trust /ID# 221334

location_facility: Hospital Clinico Universitario de Valencia /ID# 220920

location_facility: Klinikum Wels-Grieskirchen GmbH /ID# 220915

location_facility: Nippon Medical School Hospital /ID# 221676

location_facility: Seoul National University Hospital /ID# 219060

location_facility: Universitatsklinikum Mannheim /ID# 221529

location_facility: Clin Hosp Ctr Bezanijska Kosa /ID# 231059

location_facility: University Clinical Center Serbia /ID# 231058

location_facility: Stauferklinikum Schwaebisch Gmuend /ID# 223948

location_facility: Universitaetsklinikum St. Poelten /ID# 221709

location_facility: Hadassah Medical Center-Hebrew University /ID# 219111

location_facility: Ege University Medical Faculty /ID# 224570

location_facility: Wake Forest Baptist Medical Center /ID# 222899

location_facility: Hospital Universitario Dr. Negrin /ID# 220923

location_facility: James Paget University Hospitals NHS Foundation Trust /ID# 221219

location_facility: Vseobecna fakultni nemocnice v Praze /ID# 220969

location_facility: A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 219089

location_facility: CISSS-CA (Centre Integre de sante et de services sociaux de Chaudiere-Appalache) /ID# 222433

location_facility: MTZ Clinical Research Powered by Pratia /ID# 221759

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 220947

location_facility: Memorial Sloan Kettering Cancer Center-Koch Center /ID# 221081

location_facility: A.O.U. Citta della Salute e della Scienza di Torino /ID# 221223

location_facility: Trakya University Medical Facu /ID# 224572

location_facility: Loyola University Medical Ctr /ID# 219048

location_facility: Dokkyo Medical University Saitama Medical Center /ID# 222334

location_facility: Fejer Megyei Szent Gyorgy Korhaz /ID# 220949

location_facility: National Cancer Center Hospital East /ID# 226653

location_facility: Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 221241

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 221161

location_facility: Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 221526

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz Josa Andras Okta /ID# 220946

location_facility: Hospital Universitario Vall d'Hebron /ID# 240979

location_facility: Universitaetsmedizin Rostock /ID# 224157

location_facility: Dana-Farber Cancer Institute /ID# 218998

location_facility: Kaohsiung Chang Gung Memorial Hospital /ID# 218985

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 238438

location_facility: Highlands Oncology Group, PA /ID# 221826

location_facility: General Hospital of Athens Laiko /ID# 221175

location_facility: Hospital Universitario 12 de Octubre /ID# 233726

location_facility: University of Texas Health San Antonio MD Anderson Cancer Center /ID# 233942

location_facility: Hospital Universitario La Paz /ID# 224813

location_facility: St. Mary's Hospital Regional Cancer Center /ID# 224229

location_facility: Haematologisch-Onkologische Praxis im Zentrum Augsburg /ID# 225025

location_facility: The Cancer Institute at St. Francis Hospital /ID# 231782

location_facility: Uniwersyteckie Centrum Kliniczne /ID# 221298

location_facility: Pusan National University Hospital /ID# 220980

location_facility: University General Hospital of Patras /ID# 221178

location_facility: Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 221220

location_facility: Augusta University Georgia Cancer Center /ID# 219051

location_facility: Tula Regional Clinical Hospital /ID# 221302

location_facility: Ottawa Hospital Research Institute /ID# 238858

location_facility: Juntendo University Hospital /ID# 221154

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 221077

location_facility: Skane University Hospital Lund /ID# 220834

location_facility: Azienda Ospedaliera Universitaria Federico II /ID# 224673

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 220948

location_facility: Indiana Blood & Marrow Transpl /ID# 221587

location_facility: Summit Medical Group-Florham Park /ID# 222620

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 221179

location_facility: Centre Hospitalier de CHAMBERY /ID# 223771

location_facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 221616

location_facility: Utah Cancer Specialists Salt Lake Clinic /ID# 221962

location_facility: The Lady Davis Carmel Medical Center /ID# 222973

location_facility: Iwate Medical University Hospital /ID# 222044

location_facility: Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 221078

location_facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 225731

location_facility: Tokyo Medical University Hospital /ID# 221540

location_facility: OncoResearch Lerchenfeld GmbH /ID# 225034

location_facility: Hospital Universitario Virgen del Rocio /ID# 221932

location_facility: Linkou Chang Gung Memorial Hospital /ID# 218982

location_facility: Assaf Harofeh Medical Center /ID# 222972

location_facility: Medizinische Universitaet Graz /ID# 220919

location_facility: University of Rochester Medical Center /ID# 219050

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola /ID# 241031

location_facility: Acibadem City Clinic Tokuda University Hospital EAD /ID# 231649

location_facility: University of Yamanashi Hospital /ID# 221706

location_facility: Taipei Veterans General Hosp /ID# 221147

location_facility: Guys and St Thomas NHS Foundation Trust /ID# 221041

location_facility: Hospital Universitario de Salamanca /ID# 221904

location_facility: Hospital Parc de Salut del Mar /ID# 220922

location_facility: University of Miyazaki Hospital /ID# 221821

location_facility: Albert Alberts Stem Cell Transplant Centre /ID# 231556

location_facility: United Lincolnshire Hospitals NHS Trust /ID# 224613

location_facility: China Medical University Hospital /ID# 218979

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 221222

location_facility: Saint Louis University Cancer Center /ID# 222287

location_facility: Long Beach Memorial Medical Ct /ID# 224542

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 219127

location_facility: Columbus Regional Research Institute /ID# 224410

location_facility: Fujita Health University Hospital /ID# 221598

location_facility: Fukushima Medical University Hospital /ID# 221877

location_facility: Manhattan Hematology Oncology MHO Associates /ID# 223193

location_facility: LUX MED Onkologia - Szpital Szamocka /ID# 221265

location_facility: Ochsner Clinic Foundation-New Orleans /ID# 222777

location_facility: Almazov National Medical Research Centre /ID# 221114

location_facility: Hospital Universitario Central de Asturias /ID# 224815

location_facility: Augusta-Kranken-Anstalt gGmbH, Bochum-Mitte /ID# 224695

summary:
Myelofibrosis (MF) is a bone marrow illness that affects blood-forming tissues in the body. MF disturbs the body's normal production of blood cells, causing extensive scarring in the bone marrow. This leads to severe anemia, weakness, fatigue, and an enlarged spleen. The purpose of this study is to assess safety and change in spleen volume when navitoclax is given in combination with ruxolitinib, as compared to best available therapy, for adult participants with MF.

Navitoclax is an investigational drug (not yet approved) being developed for the treatment of MF. The study has 2 arms - A and B. In Arm A, participants will receive navitoclax in combination with ruxolitinib. In Arm B, participants will receive the best available therapy (BAT) for MF. Adult participants with a diagnosis of relapsed/refractory (R/R) MF will be enrolled. Approximately 330 participants will be enrolled in approximately 210 sites across the world.

In Arm A, participants will receive oral navitoclax tablet once daily with oral ruxolitinib tablet twice daily. In Arm B, participants will receive the BAT as identified by the investigator. Treatment will continue until clinical benefit is not seen, participants cannot tolerate the study drugs, or participants withdraw consent. The approximate treatment duration is about 3 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires.


title: Evaluation of the Efficacy of Elastic Compression in Preventing Post-thrombotic Syndrome. Randomised Non-inferiority Study for Ankle Pressure Targeted at 25 mm Hg Versus 35 mm Hg

acronym: CELEST

summary:
Post thrombotic syndrome (PTS) is a frequent and burdensome complication of proximal deep-vein thrombosis.Therapeutic options for PTS are limited and mainly rely on its prevention. Therapeutic trials evidenced that elastic compression stockings (ECS) applying 30-40mmHg of pressure at the ankle reduced the rate of PTS by 50%. Although ECS are unlikely to cause harm, in clinical practice, compliance to this treatment appears to be low as ECS may be difficult to apply and to wear.

ECS with a lighter compression strength (20-30mmHg) might be easier to apply and be more comfortable. This could favor a better compliance.

CELEST is a randomized, multicentre, double-blind trial which aims to determine whether ECS applying 25mmHg of targeted pressure at the ankle are non inferior to ECS applying 35mmHg of targeted pressure at the ankle

ReferenceCitation: Fowkes FJ, Price JF, Fowkes FG. Incidence of diagnosed deep vein thrombosis in the general population: systematic review. Eur J Vasc Endovasc Surg. 2003 Jan;25(1):1-5. Review.

ReferenceCitation: Oger E. Incidence of venous thromboembolism: a community-based study in Western France. EPI-GETBP Study Group. Groupe d'Etude de la Thrombose de Bretagne Occidentale. Thromb Haemost. 2000 May;83(5):657-60.

ReferenceCitation: Prandoni P, Kahn SR. Post-thrombotic syndrome: prevalence, prognostication and need for progress. Br J Haematol. 2009 May;145(3):286-95. doi: 10.1111/j.1365-2141.2009.07601.x. Epub 2009 Feb 13. Review.

ReferenceCitation: Prandoni P, Lensing AW, Cogo A, Cuppini S, Villalta S, Carta M, Cattelan AM, Polistena P, Bernardi E, Prins MH. The long-term clinical course of acute deep venous thrombosis. Ann Intern Med. 1996 Jul 1;125(1):1-7.

ReferenceCitation: Prandoni P, Villalta S, Bagatella P, Rossi L, Marchiori A, Piccioli A, Bernardi E, Girolami B, Simioni P, Girolami A. The clinical course of deep-vein thrombosis. Prospective long-term follow-up of 528 symptomatic patients. Haematologica. 1997 Jul-Aug;82(4):423-8.

ReferenceCitation: Gabriel F, Labiós M, Portolés O, Guillén M, Corella D, Francés F, Martínez M, Gil J, Saiz C. Incidence of post-thrombotic syndrome and its association with various risk factors in a cohort of Spanish patients after one year of follow-up following acute deep venous thrombosis. Thromb Haemost. 2004 Aug;92(2):328-36.

ReferenceCitation: Kahn SR, Ginsberg JS. Relationship between deep venous thrombosis and the postthrombotic syndrome. Arch Intern Med. 2004 Jan 12;164(1):17-26. Review.

ReferenceCitation: Kahn SR, Hirsch A, Shrier I. Effect of postthrombotic syndrome on health-related quality of life after deep venous thrombosis. Arch Intern Med. 2002 May 27;162(10):1144-8.

ReferenceCitation: Bergqvist D, Jendteg S, Johansen L, Persson U, Odegaard K. Cost of long-term complications of deep venous thrombosis of the lower extremities: an analysis of a defined patient population in Sweden. Ann Intern Med. 1997 Mar 15;126(6):454-7.

ReferenceCitation: Brandjes DP, Büller HR, Heijboer H, Huisman MV, de Rijk M, Jagt H, ten Cate JW. Randomised trial of effect of compression stockings in patients with symptomatic proximal-vein thrombosis. Lancet. 1997 Mar 15;349(9054):759-62.

ReferenceCitation: Prandoni P, Lensing AW, Prins MH, Frulla M, Marchiori A, Bernardi E, Tormene D, Mosena L, Pagnan A, Girolami A. Below-knee elastic compression stockings to prevent the post-thrombotic syndrome: a randomized, controlled trial. Ann Intern Med. 2004 Aug 17;141(4):249-56.

ReferenceCitation: Milne AA, Ruckley CV. The clinical course of patients following extensive deep venous thrombosis. Eur J Vasc Surg. 1994 Jan;8(1):56-9.

ReferenceCitation: Partsch H, Blättler W. Compression and walking versus bed rest in the treatment of proximal deep venous thrombosis with low molecular weight heparin. J Vasc Surg. 2000 Nov;32(5):861-9.

ReferenceCitation: Kahn SR, Elman E, Rodger MA, Wells PS. Use of elastic compression stockings after deep venous thrombosis: a comparison of practices and perceptions of thrombosis physicians and patients. J Thromb Haemost. 2003 Mar;1(3):500-6.

ReferenceCitation: Benkö T, Cooke EA, McNally MA, Mollan RA. Graduated compression stockings: knee length or thigh length. Clin Orthop Relat Res. 2001 Feb;(383):197-203.

ReferenceCitation: Sajid MS, Tai NR, Goli G, Morris RW, Baker DM, Hamilton G. Knee versus thigh length graduated compression stockings for prevention of deep venous thrombosis: a systematic review. Eur J Vasc Endovasc Surg. 2006 Dec;32(6):730-6. Epub 2006 Aug 23. Review.

ReferenceCitation: Nelson EA, Harper DR, Prescott RJ, Gibson B, Brown D, Ruckley CV. Prevention of recurrence of venous ulceration: randomized controlled trial of class 2 and class 3 elastic compression. J Vasc Surg. 2006 Oct;44(4):803-8.

ReferenceCitation: Arpaia G, Cimminiello C, Mastrogiacomo O, de Gaudenzi E. Efficacy of elastic compression stockings used early or after resolution of the edema on recanalization after deep venous thrombosis: the COM.PRE Trial. Blood Coagul Fibrinolysis. 2007 Mar;18(2):131-7.

ReferenceCitation: Roumen-Klappe EM, den Heijer M, van Rossum J, Wollersheim H, van der Vleuten C, Thien T, Janssen MC. Multilayer compression bandaging in the acute phase of deep-vein thrombosis has no effect on the development of the post-thrombotic syndrome. J Thromb Thrombolysis. 2009 May;27(4):400-5. doi: 10.1007/s11239-008-0229-7. Epub 2008 May 15.

ReferenceCitation: Delluc A, Gouedard C, De Saint Martin L, Garcia C, Roguedas AM, Bressollette L, Misery L, Mottier D, Le Gal G. [Incidence, risk factors and skin manifestations of post-thrombotic syndrome: a four-year follow-up of patients included in the EDITH study]. Rev Med Interne. 2010 Nov;31(11):729-34. doi: 10.1016/j.revmed.2010.07.018. Epub 2010 Sep 29. French.

lead_sponsor: Laboratoires Innothera

location_facility:
CH Pierre-Bénite
Clinique Victor PAUCHET
Chu Clermont-Ferrand
Hia Brest
Cabinet
Chu Grenoble
CHU
Hôpital du bocage
Chu St Etienne
CH Mâcon
HEGP
Hopital Saint Philibert
CHR Orléans
Hôpital St Joseph
Centre Hospitalier d'Armentieres
CH Armentières
Ch Bourgoin-Jallieu
Chu Brest
Chru Lille
Chu Angers
CH de Chambéry
CHRU Amiens
CHU Gabriel Montpied
Chu Montpellier
Ch Chalon Sur Saone
Chu Toulouse
Ch La Rochelle
Chu Hotel Dieu
Chra Annecy


title: A Phase 3 Randomized, Controlled, Open-label Study of Selinexor, Bortezomib, and Dexamethasone (SVd) Versus Bortezomib and Dexamethasone (Vd) in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

acronym: BOSTON

summary: This Phase 3, 2-arm, randomized, active comparator-controlled, open-label, multicenter study will compare the efficacy and health-related quality of life (HR-QoL) and assess the safety of selinexor plus bortezomib (Velcade) plus low-dose dexamethasone (SVd) versus bortezomib plus low-dose dexamethasone (Vd) in adult patients with RRMM who have received 1 to 3 prior anti-multiple myeloma (MM) regimens. Crossover from the Vd Arm to a treatment that includes selinexor (i.e., SVdX or SdX) will be allowed at the point of IRC-confirmed objective disease progression per the IMWG criteria for patients in the Vd Arm.

ReferenceCitation: Delimpasi S, Mateos MV, Auner HW, Gavriatopoulou M, Dimopoulos MA, Quach H, Pylypenko H, Hájek R, Leleu X, Dolai TK, Sinha DK, Venner CP, Benjamin R, Garg MK, Doronin V, Levy Y, Moreau P, Chai Y, Arazy M, Shah J, Shacham S, Kauffman MG, Richardson PG, Grosicki S. Efficacy and tolerability of once-weekly selinexor, bortezomib, and dexamethasone in comparison with standard twice-weekly bortezomib and dexamethasone in previously treated multiple myeloma with renal impairment: Subgroup analysis from the BOSTON study. Am J Hematol. 2022 Mar 1;97(3):E83-E86. doi: 10.1002/ajh.26434. Epub 2021 Dec 29.

ReferenceCitation: Richard S, Chari A, Delimpasi S, Simonova M, Spicka I, Pour L, Kriachok I, Dimopoulos MA, Pylypenko H, Auner HW, Leleu X, Usenko G, Hajek R, Benjamin R, Dolai TK, Sinha DK, Venner CP, Garg M, Stevens DA, Quach H, Jagannath S, Moreau P, Levy M, Badros A, Anderson LD Jr, Bahlis NJ, Facon T, Mateos MV, Cavo M, Chang H, Landesman Y, Chai Y, Arazy M, Shah J, Shacham S, Kauffman MG, Grosicki S, Richardson PG. Selinexor, bortezomib, and dexamethasone versus bortezomib and dexamethasone in previously treated multiple myeloma: Outcomes by cytogenetic risk. Am J Hematol. 2021 Sep 1;96(9):1120-1130. doi: 10.1002/ajh.26261. Epub 2021 Jul 5.

ReferenceCitation: Mateos MV, Gavriatopoulou M, Facon T, Auner HW, Leleu X, Hájek R, Dimopoulos MA, Delimpasi S, Simonova M, Špička I, Pour L, Kriachok I, Pylypenko H, Doronin V, Usenko G, Benjamin R, Dolai TK, Sinha DK, Venner CP, Garg M, Stevens DA, Quach H, Jagannath S, Moreau P, Levy M, Badros AZ, Anderson LD Jr, Bahlis NJ, Cavo M, Chai Y, Jeha J, Arazy M, Shah J, Shacham S, Kauffman MG, Richardson PG, Grosicki S. Effect of prior treatments on selinexor, bortezomib, and dexamethasone in previously treated multiple myeloma. J Hematol Oncol. 2021 Apr 13;14(1):59. doi: 10.1186/s13045-021-01071-9.

ReferenceCitation: Auner HW, Gavriatopoulou M, Delimpasi S, Simonova M, Spicka I, Pour L, Dimopoulos MA, Kriachok I, Pylypenko H, Leleu X, Doronin V, Usenko G, Hajek R, Benjamin R, Dolai TK, Sinha DK, Venner CP, Garg M, Stevens DA, Quach H, Jagannath S, Moreau P, Levy M, Badros A, Anderson LD Jr, Bahlis NJ, Facon T, Mateos MV, Cavo M, Chai Y, Arazy M, Shah J, Shacham S, Kauffman MG, Richardson PG, Grosicki S. Effect of age and frailty on the efficacy and tolerability of once-weekly selinexor, bortezomib, and dexamethasone in previously treated multiple myeloma. Am J Hematol. 2021 Jun 1;96(6):708-718. doi: 10.1002/ajh.26172. Epub 2021 May 3.

ReferenceCitation: Grosicki S, Simonova M, Spicka I, Pour L, Kriachok I, Gavriatopoulou M, Pylypenko H, Auner HW, Leleu X, Doronin V, Usenko G, Bahlis NJ, Hajek R, Benjamin R, Dolai TK, Sinha DK, Venner CP, Garg M, Gironella M, Jurczyszyn A, Robak P, Galli M, Wallington-Beddoe C, Radinoff A, Salogub G, Stevens DA, Basu S, Liberati AM, Quach H, Goranova-Marinova VS, Bila J, Katodritou E, Oliynyk H, Korenkova S, Kumar J, Jagannath S, Moreau P, Levy M, White D, Gatt ME, Facon T, Mateos MV, Cavo M, Reece D, Anderson LD Jr, Saint-Martin JR, Jeha J, Joshi AA, Chai Y, Li L, Peddagali V, Arazy M, Shah J, Shacham S, Kauffman MG, Dimopoulos MA, Richardson PG, Delimpasi S. Once-per-week selinexor, bortezomib, and dexamethasone versus twice-per-week bortezomib and dexamethasone in patients with multiple myeloma (BOSTON): a randomised, open-label, phase 3 trial. Lancet. 2020 Nov 14;396(10262):1563-1573. doi: 10.1016/S0140-6736(20)32292-3.

ipd_sharing: Undecided

lead_sponsor: Karyopharm Therapeutics Inc

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Belgium
Czechia
Poland
Austria
Australia
Russian Federation
India
Israel
Canada
Hungary
Germany
Bulgaria
Greece
France

location_facility: University Hospital in Krakow, Teaching Unit of the Hematology Department

location_facility: Medical University Innsbruck, Department of Internal Medicine V (Hematology and Oncology)

location_facility: University Clinical Hospital of Salamanca, Department of Hematology

location_facility: University Hospital San Giovanni Battista of Turin

location_facility: Hospital Center Departmental La Roche-Sur-Yon

location_facility: University Hospitals Birmingham NHS Foundation Trust Queen Elizabeth Hospital

location_facility: Cardiff & Vale University Health Board University Hospital of Wales

location_facility: Colentina Clinical Hospital, Department of Hematology

location_facility: University Hospital Krems, Department of Internal Medicine II

location_facility: Polyclinic S. Orsola-Malpighi, Department of Hematology, Oncology and Laboratory Medicine, Operative Unit of Hematology - Cavo

location_facility: University Hospital Ostrava, Dept. of Hematooncology

location_facility: Azienda Ospedaliero-Universitaria Ospedali Riuniti

location_facility: Saskatchewan Cancer Agency-Allan Blair Cancer Centre

location_facility: Group Practice for Hematology and Oncology

location_facility: University Hospital San Martino, IRCCA, Dept. of Integrative Cancer Therapies, Operative Unit of Clinical Hematology

location_facility: Boca Raton Clinical Research (BRCR) Medical Center

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: Independent Public Teaching Hospital No.1 in Lublin, Department of Hematology-Oncology and Bone Marrow Transplantation

location_facility: Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz, Department of Hematology

location_facility: Clinical Center Kragujevac, Clinic of Hematology

location_facility: University Hospital of the Canary Islands

location_facility: Netaji Subhash Chandra Bose Cancer Research Institute

location_facility: Clinical Center Nis, Clinic of Hematology and Clinical Immunology

location_facility: Cross Cancer Institute / University of Alberta

location_facility: Specialized Hospital for Active Treatment of Hematological Diseases, Clinic of Hematology, Dept. of Clinical Hematology

location_facility: Semmelweis University, 1st Department of Internal Medicine

location_facility: O.F. Herbachevskyi Regional Clinical Hospital, Hematology Department with Intensive Therapy Wards

location_facility: The Royal Wolverhampton NHS Trust New Cross Hospital

location_facility: Clinical Center of Vojvodina, Clinic of Hematology

location_facility: University Hospital Infanta Leonor, Department of Hematology

location_facility: Stormont Vail Health Care (Cotton O'Neil Cancer Center )

location_facility: First I.P. Pavlov State Medical University of St. Petersburg

location_facility: Institute of Oncology and Radiology of Serbia, Clinic of Medical Oncology

location_facility: Necker Children's Hospital, Department of Adult Hematology

location_facility: Umberto I Polyclinic of Rome, Department of Cellular Biotechnology and Hematology, Hematology Center

location_facility: Clinical Center of Serbia, Clinic of Hematology

location_facility: Bucharest University Emergency Hospital, Department of Hematology

location_facility: Imperial College Healthcare NHS Trust Hammersmith Hospital

location_facility: The Cancer Institute at St. Francis Hospital

location_facility: Catalan Institute of Oncology (ICO) Badalona

location_facility: Military Institute of Medicine, Department of Internal Medicine and Hematology

location_facility: Miletrie Hospital, University Hospital Center of Poitiers

location_facility: Royal Liverpool & Broadgreen University Hospital NHS Trust Royal Liverpool University Hospital

location_facility: Brabois Adults Hospital, University Hospital Center of Nancy

location_facility: Semmelweis University, 3rd Department of Internal Medicine

location_facility: Jan Biziel University Hospital #2 in Bydgoszcz, Department of Hematology

location_facility: University Hospitals of Leicester NHS Trust Royal Leicester Infirmary

location_facility: University Hospital Kralovske Vinohrady, Clinic of Internal Hematology

location_facility: University Hospital Freiburg, Department of Internal Medicine I

location_facility: University Hospital Virgen del Rocio (HUVR)

location_facility: University Multiprofile Hospital for Active Treatment, Sveti Georgi Clinic of Clinical Hematology

location_facility: Integrated Szent Istvan and Szent laszlo Hospital, Department of Hematology and Stem Cell Transplantation

location_facility: V.A. Almazov North-West Federal Medical Research Center, Chemotherapy of Oncohematology Diseases and Bone Marrow Transplantation Department #1

location_facility: Alexandra General Hospital, Therapeutic Clinic

location_facility: Hyperclnical MedLife PDR Vulturului Brasov, Hematology Department

location_facility: London North West Healthcare NHS Trust Northwick Park Hospital

location_facility: City Clinical Hospital No.4 of Dnipro City Council, City hematology center

location_facility: University Multiprofile Hospital for Active Treatment, Sveti Ivan Rilski Clinic of Hematology

location_facility: Klinikum Leverkusen gGmbH Medizinisxhe Klinik 3

location_facility: Theageneion Cancer Hospital, Hematology Department

location_facility: Kaposi Mor Teaching Hospital, 2nd Department of Internal Medicine

location_facility: Independent Public Healthcare Facility Municipal Hospital Group in Chorzow, Department of Hematology

location_facility: The Leeds Teaching Hospitals NHS Trust St. James University Hospital

location_facility: University Hospital Careggi, Department of Hematology

location_facility: Postgraduate Institute of Medical Education & Research (PGIMER)

location_facility: St. John of Dukla Oncology Center of Lublin, Department of Hematology

location_facility: Vinnytsia M.I. Pyrohov Regional Clinical Hospital, Department of Hematology

location_facility: Belfast Heatlh & Social Care Trust Belfast City Hospital

location_facility: Institute of Blood Pathology and Transfusion Medicine, Department of Hematology with Laboratory Group

location_facility: Cherkasy Regional Oncology Center, Regional Treatment and Diagnostic Hematology Center, Department of Hematology

location_facility: Mater Misericordiae Limited and Mater Medical Research

location_facility: General Hospital of Athens "Evangelismos", Department of Hematology and Lymphoma

location_facility: Tom Baker Cancer Center/ Alberta Health Services

location_facility: Wilhelminen Hospital, Department of Internal Medicine I, Center for Oncology & Hematology

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Hospital Niguerda Ca Granda, Department of Hematology and Oncology, Hematology Unit

location_facility: Medical Center of the University of Pecs, Department of Hematology

location_facility: N.A. Semashko Central Clinical Hospital #2 under OJSC Russian Railways

location_facility: Royal Victoria Hospital / McGill University


title: A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination With Temozolomide or Veliparib in Combination With Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects With BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer

summary: The primary objective of the study is to assess the progression-free survival (PFS) of oral veliparib in combination with TMZ or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in subjects with BRCA1 or BRCA2 mutation and locally recurrent or metastatic breast cancer.

ReferenceCitation: Han HS, Diéras V, Robson M, Palácová M, Marcom PK, Jager A, Bondarenko I, Citrin D, Campone M, Telli ML, Domchek SM, Friedlander M, Kaufman B, Garber JE, Shparyk Y, Chmielowska E, Jakobsen EH, Kaklamani V, Gradishar W, Ratajczak CK, Nickner C, Qin Q, Qian J, Shepherd SP, Isakoff SJ, Puhalla S. Veliparib with temozolomide or carboplatin/paclitaxel versus placebo with carboplatin/paclitaxel in patients with BRCA1/2 locally recurrent/metastatic breast cancer: randomized phase II study. Ann Oncol. 2018 Jan 1;29(1):154-161. doi: 10.1093/annonc/mdx505.

ReferenceCitation: Isakoff SJ, Puhalla S, Domchek SM, Friedlander M, Kaufman B, Robson M, Telli ML, Diéras V, Han HS, Garber JE, Johnson EF, Maag D, Qin Q, Giranda VL, Shepherd SP. A randomized Phase II study of veliparib with temozolomide or carboplatin/paclitaxel versus placebo with carboplatin/paclitaxel in BRCA1/2 metastatic breast cancer: design and rationale. Future Oncol. 2017 Feb;13(4):307-320. doi: 10.2217/fon-2016-0412. Epub 2016 Oct 14.

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

location_country:
Denmark
Poland
Brazil
Romania
Spain
Russian Federation
Australia
Argentina
Canada
Finland
Ukraine
Sweden
Hungary
United States
France
Israel
Belgium
Norway
Netherlands
Czechia

location_facility: Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 94975

location_facility: Hospital General Universitario Gregorio Maranon /ID# 97417

location_facility: Hospital Clinico Universitario de Valencia /ID# 97975

location_facility: Communal non-profit enterprise Regional Center of Oncology /ID# 97696

location_facility: Rush University Medical Center /ID# 65489

location_facility: Northwestern University Feinberg School of Medicine /ID# 60755

location_facility: Cedars-Sinai Medical Center - West Hollywood /ID# 60760

location_facility: Soroka University Medical Center /ID# 65180

location_facility: Haukeland University Hospital /ID# 67982

location_facility: University of Arkansas for Medical Sciences /ID# 60750

location_facility: University of Alabama at Birmingham - Main /ID# 62994

location_facility: Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 63941

location_facility: UT Southwestern Medical Center /ID# 60745

location_facility: Houston Methodist Hospital - Scurlock Tower /ID# 60742

location_facility: Hospital Santa Creu i Sant Pau /ID# 97418

location_facility: Massachusetts General Hospital /ID# 64582

location_facility: Institut de Cancer de l'Ouest /ID# 63927

location_facility: Wielkopolskie Centrum Onkologi /ID# 71061

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 63928

location_facility: Hospital Universitario Virgen de la Victoria /ID# 97976

location_facility: lnstitutul Oncologic Trestiore /ID# 96742

location_facility: Pyatigorsk Oncology Dispensary /ID# 65264

location_facility: Memorial Sloan Kettering Cancer Center-Koch Center /ID# 63222

location_facility: Gastroenterology Institute, Division of Medicine /ID# 63931

location_facility: Hospital Universitario Vall d'Hebron /ID# 97415

location_facility: Inst Oncology Prof. Chiricuta /ID# 96740

location_facility: The Angeles Clinic and Researc /ID# 60743

location_facility: Banner MD Anderson Cancer Ctr /ID# 118695

location_facility: Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 63940

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 65178

location_facility: Rigshospitalet, Finsen Centre /ID# 67822

location_facility: Hospital Universitario HM Sanchinarro /ID# 97416

location_facility: Medical University of South Carolina /ID# 60752

location_facility: Spitalul Clinic Judetean de Urgenta /ID# 96741

location_facility: Washington University-School of Medicine /ID# 62724

location_facility: Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 97697

location_facility: Chelyabinsk Reg Clin Oncology /ID# 63938

location_facility: Cliniques Universitaires Saint Luc /ID# 96135

location_facility: AZ St-Jan Brugge-Oostende AV /ID# 107315

location_facility: Centrum Onkologii Lukaszczyka /ID# 73393

location_facility: Pays-Basque Ctr Oncology/Radio /ID# 65176

location_facility: Duke University Medical Center /ID# 60747

location_facility: Florida Cancer Specialists - East /ID# 60762

location_facility: State Regional Budgetary Healthcare Institution " Murmansk Regional Oncology Dis /ID# 102415

location_facility: N.N. Petrov Research Inst Onc /ID# 65269

location_facility: University of Illinois - Chicago /ID# 106175

location_facility: Hospital de Clinicas de Porto Alegre /ID# 65242

location_facility: Municipal Non-Profit Enterprise of Sumy Regional Council Sumy Regional Clinical /ID# 65280

location_facility: N.N. Petrov Research Inst Onc /ID# 78973

location_facility: Univ of Colorado Cancer Center /ID# 60751

location_facility: Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 65263

location_facility: Sunnybrook Health Sciences Ctr /ID# 77373

location_facility: Southern Medical Day Care Ctr /ID# 63274

location_facility: Stanford University School of Med /ID# 65488

location_facility: Hospital Bruno Born / Sociedade Beneficencia e Caridade de Lajeado /ID# 65247

location_facility: Penn State University and Milton S. Hershey Medical Center /ID# 62723

location_facility: Moore UC San Diego Cancer Center /ID# 60754


title: Assessment and Monitoring of Renal Proximal Tubular Tolerance of Nucleoside and Nucleotide Analogues Using Early Screening Tools in Patients Chronically Mono-infected With Hepatitis B Virus.

acronym: HBVSECURE

summary: Nucleotide analogues are associated in the long term with a risk of proximal tubular nephropathy (PT) with loss of phosphate, and, when compensatory mechanisms are overwhelmed, with osteopenia or osteoporosis. This toxicity has been particularly documented for tenofovir (TDF) in HIV disease, but its prevalence varies widely in the literature and is mainly associated with comorbidities: on average this prevalence is 0.39% after 48 weeks with exceptional cases of Fanconi syndrome described. In HBV monoinfection after 60 months of treatment with TDF, an 11% decrease of creatinine clearance (CreatCl) is observed. A single study showed a significant increase in creatinine level with entecavir (ETV) therapy, a second-generation nucleoside, hitherto not described as nephrotoxic. Furthermore, if the direct renal toxic effect characteristic of HIV in the kidney is well known, the role of HBV is less clear. Thus, HBV treatment appears to have a renal protective effect. The monitoring tools recommended by the SPC, CreatCl and plasma phosphorus level are late markers of tubular damage. The threshold of phosphate tubular reabsorption (TmPi/GFR) and the fractional excretion of uric acid (FEUA) are unexpensive early screening tools. However, the long-term evolution of this subclinical tubular involvement in HBV monoinfection is not known.

lead_sponsor: University Hospital, Limoges

location_facility: Hospices Civils de Lyon - Hôpital Croix Rousse


title: A Patient Cohort With Locally Advanced or Metastatic Non-small Cell Lung Cancer Treated With Tarceva (Erlotinib) Monotherapy and Not Progressing After at Least 9 Months

summary: This prospective, multi-center, observational study will assess the progression-free survival and safety of patients with locally advanced or metastatic non-small cell lung cancer treated with Tarceva (erlotinib) and not disease progressing after at least 9 months. Data will be collected for 24 months.


title: Non Interventional Study Aimed to Describe the Management of Relapse or Refractory Chronic Lymphocytic Leukemia (CLL) Patients Retreated by MabThera

summary: This multi-center, prospective, observational study will describe the management of relapsing or refractory chronic lymphocytic leukemia (CLL) patients. Data will be collected for 2 years.


title: InSaKa Trial: Insulin Dextrose Infusion Versus Nebulized Salbutamol Versus Combination of Salbutamol and Insulin Dextrose in Acute Hyperkalemia: a Randomized Clinical Trial

acronym: InSaKa

summary:
Hyperkalemia is a common electrolyte disorder, especially among patients with chronic kidney disease, diabetes mellitus, or heart failure. Globally, the reported incidence of hyperkalemia varies from 1.1 to 10 per 100 hospitalizations, depending on the patient cohort and comorbidities. Hyperkalemia is a potentially life-threatening electrolyte disturbance that can be fatal if left untreated. Several studies have established the association between hyperkalemia and all-cause mortality. Because of the deleterious cardiac effects of hyperkalemia, its management is an emergency intervention. However, robust evidence is lacking to guide the emergency management of patients with hyperkalemia. Emergency treatment approaches are largely based on small studies, anecdotal experience, and traditionally accepted practice patterns within institutions. Therefore, a rigorous evaluation of the first-line treatments of hyperkalemia in emergency departments is needed and a large scale randomized clinical trial is warranted before robust recommendations for clinical practice can be made. Our clinical trial will improve the safety of patients with acute hyperkalemia and will help clinicians in their day by day practice to choose the treatment that significantly reduces morbidity and mortality during acute hyperkalemia management. Our results will be delivered in a timely fashion, owing to the high prevalence of hyperkalemia in the emergency department setting and to the commitment of the INI-CRCT network of Excellence, along with ED specialists used to work jointly.

the primary objective of our trial is to compare insulin/dextrose intravenous infusion, nebulized salbutamol or combination of nebulized salbutamol and insulin/dextrose intravenous infusion to reduce serum potassium concentration at 60 minutes, as first-line treatment, in emergency departments.

ReferenceCitation: Montassier E, Lemoine L, Hardouin JB, Rossignol P, Legrand M. Insulin glucose infusion versus nebulised salbutamol versus combination of salbutamol and insulin glucose in acute hyperkalaemia in the emergency room: protocol for a randomised, multicentre, controlled study (INSAKA). BMJ Open. 2020 Aug 26;10(8):e039277. doi: 10.1136/bmjopen-2020-039277.

ipd_sharing_description: Trial data are not publicly available owing to data privacy, but access to the anonymised dataset can be obtained from the corresponding author on reasonable request.

location_facility: La Pitié Salpêtrière University Hospital