title: Comparison of Trough Level-based Spacing and Clinical-based Spacing of Infliximab Infusions in Patients With Inflammatory Bowel Disease in Deep Remission; A Prospective, Multicenter, Open-label, Randomized, Controlled Study

acronym: SPACIFIX

summary: Comparison of trough level-based spacing and clinical-based spacing of infliximab infusions in patients with inflammatory bowel disease in deep remission A prospective, multicenter, open-label, randomized, controlled Study

lead_sponsor: University Hospital, Montpellier

location_facility:
Lille University Hospital
Amiens University Hospital
Pineton de Chambrun
Nice University Hospital
Toulouse University Hospital
Besançon University Hospital
Saint Etienne University Hospital
APHP Beaujon Hospital
Rennes University Hospital
Clermont-Ferrand University Hospital
Nîmes University Hospital
Bordeaux University Hospital
Caen University Hospital
CHRU Nancy - Hôpitaux de Brabois
APHP Paris Cochin
Nantes University Hospital


title: Erectile Dysfunction in Good Prognosis Prostate Cancer: a Phase III Medico-economic Study Comparing Brachytherapy to Stereotactic Body Radiotherapy

acronym: TEMPOS

summary:
The TEMPOS-GEniToUrinary Group (GETUG) study is a multicenter, medico-economic study comparing brachytherapy to SBRT in low and intermediate risk prostate cancer, particularly focused on the issue of erectile dysfunction. A total of 240 potent patients are randomized in two arms. The experimental arm consists of SBRT delivering 7.25 Gy per fraction, in five fractions, corresponding to a total dose of 36.25 Gy to the prostate. The control arm consists of brachytherapy by Iodine 125 delivering 144 Gy to the prostate. The main objective of this health economics study is to perform a cost-utility analysis of SBRT compared to "standard" Iodine 125 brachytherapy in low-risk prostate cancer, 3 years after treatment. The endpoint is the Incremental Cost-Utility Ratio (ICUR) between SBRT and brachytherapy as primary criterion, expressed in cost per quality adjusted life year (QALY) gained. Cost-effectiveness analyses are performed as secondary objective with Incremental Cost-Effectiveness Ratios (ICERs) expressed as cost per erectile dysfunction avoided and cost per Life Year Gained. A long term evaluation is also performed, including a cost-utility, cost-effectiveness and budget impact analysis at 5 years, a comprehensive assessment of the erectile dysfunction up to 5 years after treatment, an evaluation of acute and late genito-urinary (GU) and Gastro-Intestinal (GI) toxicities, and of quality of life up to 5 years after treatment.

Eight patients/year/center are expected to be recruited in 2 years in about twenty participating centers.

In total, to our knowledge, this study will be the first health economic evaluation which compares SBRT versus Iodine 125 brachytherapy in low risk and intermediate risk prostate cancer. Both cost-utility and cost-effectiveness analyses will also provide useful and complementary information to decision makers in order (i) to recommend the best strategy to adopt; (ii) to estimate the budget impact on the French National Health Insurance of the generalization of the cost-effective strategy. Finally, this study will allow to assess and compare accurately the erectile dysfunction after both treatment modalities.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Center Eugene Marquis

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

location_facility: Institut régional du Cancer de Montpellier

location_facility: Institut de Cancérologie Lucien Neuwirth

intervention_type: Radiation

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Evaluation of Clinical and Imaging Criteria, and Plasma Biomarkers of Patients Receiving an Endovascular Treatment for an Acute Ischemic Stroke

acronym: ETIS

summary: Study like register with biomarkers samples for patient experiencing acute ischemic stroke, to assess clinical outcomes and different factors that may affect the clinical outcomes.

study_type: Observational

time_perspective: Other

ReferenceType: derived

ReferenceCitation: Douarinou M, Gory B, Consoli A, Lapergue B, Kyheng M, Labreuche J, Anadani M, Blanc R, Marnat G, Bourcier R, Sibon I, Eugène F, Vannier S, Audibert G, Mione G, Richard S; ETIS Investigators. Impact of Strategy on Clinical Outcome in Large Vessel Occlusion Stroke Successfully Reperfused: ETIS Registry Results. Stroke. 2022 Jan;53(1):e1-e4. doi: 10.1161/STROKEAHA.121.034422. Epub 2021 Nov 3.

ReferenceCitation: Happi Ngankou E, Gory B, Marnat G, Richard S, Bourcier R, Sibon I, Dargazanli C, Arquizan C, Maïer B, Blanc R, Lapergue B, Consoli A, Vannier S, Spelle L, Denier C, Boulanger M, Gauberti M, Saleme S, Macian F, Clarençon F, Rosso C, Naggara O, Turc G, Ozkul-Wermester O, Papagiannaki C, Viguier A, Cognard C, Lebras A, Evain S, Wolff V, Pop R, Timsit S, Gentric JC, Bourdain F, Veunac L, Eugène F, Finitsis S; ETIS Registry Investigators†. Thrombectomy Complications in Large Vessel Occlusions: Incidence, Predictors, and Clinical Impact in the ETIS Registry. Stroke. 2021 Dec;52(12):e764-e768. doi: 10.1161/STROKEAHA.121.034865. Epub 2021 Oct 28.

ReferenceCitation: Aubertin M, Weisenburger-Lile D, Gory B, Richard S, Blanc R, Ducroux C, Piotin M, Labreuche J, Lucas L, Dargazanli C, Benali A, Bourcier R, Detraz L, Vannier S, Guillen M, Eugene F, Walker G, Lun R, Guenego A, Consoli A, Marnat G, Maier B, Lapergue B, Fahed R; ETIS Investigators*. First-Pass Effect in Basilar Artery Occlusions: Insights From the Endovascular Treatment of Ischemic Stroke Registry. Stroke. 2021 Dec;52(12):3777-3785. doi: 10.1161/STROKEAHA.120.030237. Epub 2021 Aug 26.

ReferenceCitation: Ducroux C, Renaud N, Bourcier R, Marnat G, Sibon I, Gory B, Richard S, Dargazanli C, Arquizan C, Eugene F, Vannier S, Labreuche J, Walker G, Blanc R, Obadia M, Consoli A, Lapergue B, Fahed R; ETIS investigators. Embolus Retriever with Interlinked Cages (ERIC) versus conventional stent retrievers for thrombectomy: a propensity score-based analysis. J Neurointerv Surg. 2021 Mar;13(3):255-260. doi: 10.1136/neurintsurg-2020-016289. Epub 2020 Jun 30.

ReferenceCitation: Boisseau W, Fahed R, Lapergue B, Desilles JP, Zuber K, Khoury N, Garcia J, Maïer B, Redjem H, Ciccio G, Smajda S, Escalard S, Taylor G, Mazighi M, Michel P, Gory B, Blanc R; ETIS Investigators. Predictors of Parenchymal Hematoma After Mechanical Thrombectomy: A Multicenter Study. Stroke. 2019 Sep;50(9):2364-2370. doi: 10.1161/STROKEAHA.118.024512. Epub 2019 Jul 22.

lead_sponsor: Hopital Foch

location_facility:
CHU Nantes
CH Bretagne Atlantique
CHU de Caen
CHU Lyon
Hôpital Pitié Salpétrière
Fondation Ophtalmique de Rotschild
Hôpital Foch
CHU Montpellier
CHU Rennes
CHU Bordeaux
CHU Toulouse
CHU Nancy
Chu Rouen
Hôpital SAINTE ANNE
CHU Dupuytren
Hôpital le Kremlin-Bicètre - APHP

lead_sponsor_type: academique


primary_purpose: Prevention

intervention_type: Drug

title: Effectiveness Assessment of Riluzole in the Prevention of Oxaliplatin-induced Peripheral Neuropathy: A Phase II Randomized Study by UNICANCER With the Cooperation of AFSOS

lead_sponsor: UNICANCER

type: EudraCT Number

source: euctr

design_allocation: Randomized

ReferenceCitation: Kerckhove N, Busserolles J, Stanbury T, Pereira B, Plence V, Bonnetain F, Krakowski I, Eschalier A, Pezet D, Balayssac D. Effectiveness assessment of riluzole in the prevention of oxaliplatin-induced peripheral neuropathy: RILUZOX-01: protocol of a randomised, parallel, controlled, double-blind and multicentre study by the UNICANCER-AFSOS Supportive Care intergroup. BMJ Open. 2019 Jun 9;9(6):e027770. doi: 10.1136/bmjopen-2018-027770.

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

location_facility:
Clinique St Côme
ICO - Site Paul Papin
CH Beauvais
Centre Georges François Leclerc
CH Annecy-Genevois
Institut Jean Godinot
ICO - Site René Gauducheau
Hôpital Foch
Hia Begin
CHU de Dijon
GHPSO
CHU de Reims
Hia Percy
CHU de Saint-Etienne
Centre François Baclesse
CHU de Clermont -Ferrand

summary:
It is a phase II trial, randomized, parallel, double blind, multicenter, comparing riluzole versus placebo.

The trial population is composed of patients ≥18 years old that have developed stage II/III colorectal cancer and are eligible for Simplified FOLFOX4 (6-12 cycles) adjuvant chemotherapy.

The primary objective is to assess the preventive efficacy of riluzole on the severity of oxaliplatin-induced peripheral neuropathy during the Simplified FOLFOX4 adjuvant chemotherapy of stage II/III colorectal cancers.


ipd_sharing: Yes

status: Completed

title: A Prospective, Open-Label, Single-Arm, Phase 2, Multicenter Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Subjects With T-Cell Prolymphocytic Leukemia

study_completion_date_type: Actual

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 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.

enrollment_type: Actual

location_country:
United Kingdom
Italy
Austria
Australia
Netherlands
Finland
United States
France
Germany

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 208726

location_facility: University of Texas MD Anderson Cancer Center /ID# 207746

location_facility: Medizinische Universitaet Wien /ID# 208497

location_facility: Azienda Sanitaria Universitaria Giuliano Isontina /ID# 211487

location_facility: Dana-Farber Cancer Institute /ID# 207728

location_facility: Helsinki University Hospital /ID# 208108

location_facility: Universitair Medisch Centrum Groningen /ID# 207990

location_facility: The Royal Marsden NHS Foundation Trust /ID# 211263

location_facility: Oxford University Hospitals NHS Foundation Trust /ID# 211264

summary:
A study to evaluate the safety and efficacy of venetoclax plus ibrutinib for participants with T-cell Prolymphocytic Leukemia (T-PLL) and follows a 2-stage design as follows:

Stage 1: Enroll 14 participants with relapsed or refractory (R/R) T-PLL and move to Stage 2 if 4 or more participants meet protocol-specified response criteria. Response assessment will be performed on a continued basis until all 14 participants have enrolled into Stage 1 and have completed the Week 24 disease assessment.

Stage 2: Enroll up to an additional 23 participants.

status_simplified: Completed


title: Clinical Characteristics of Pruritus and Evaluation of Quality of Life in Patients With Bullous Pemphigoid

acronym: PRURIPB

summary:
Whereas pruritus is a major symptom in bullous pemphigoid, its characteristics and its impact on quality of life have been little studied.

The objective of this study is to learn more about pruritus characteristics of patients with bullous pemphigoid, and in consequence to better understand the pathophysiology of pruritus, and then to better treat pruritus in this condition.

time_perspective: Prospective

lead_sponsor: University Hospital, Brest

location_facility:
AP-HP, Hôpital Henri Mondor
AP-HP, Hôpital Avicenne
AP-HP, Hôpital Bichat
CHU de Rouen
CHU Caen
CH Argenteuil
CHRU de Brest
CHU de Clermont-Ferrand
CHU Le Havre
HP-HM
AP-HP, Hôpital Cochin
CHU de Bordeaux
CH de Niort
CHU de Reims
CHU de Saint-Etienne
CHU de Montpellier


title: Prospective Study Assessing the Impact of RNA Genomic Profile Defined by a Genomic Test on Treatment Decision-making in Breast Cancer Patients With an ISH Equivocal HER2 Status- EQUIVOK Study

acronym: EQUIVOK

summary:
The American Society of Clinical Oncology (ASCO) and the /College of American Pathologists (CAP) recommend that HER2 status (negative or positive) must be determined in all patients with invasive breast cancer. The knowledge of HER2 status will help the oncologist in prescribing or not a HER2-targeted therapy to patients. Presently, two main methods are used to assess HER2 status: immunohistochemistry (IHC, protein expression) and in situ hybridization (ISH, gene expression) in order to classify tumor sample as positive, negative or equivocal. When a tumor is classified HER 2+ by IHC method, a second test is performed using ISH methods (FISH, SISH, CISH). In case of HER2 equivocal result with ISH method (4 ≤HER2 gene number copy <6), the patient is eligible to an anti-HER2 therapy after discussed during MD-MM. This decision should be individualized on the basis of patient status (comorbidities and prognosis) and patient preferences after discussing available clinical evidence.

Based on molecular classification, RNA expression could help to discriminate breast cancer subtypes (luminal A, luminal B, HER2-overexpressed and triple negative). Prosigna is a genomic test, developed by NanoString® based on the PAM50 gene signature, which measures the expression of 50 genes to classify tumors into 1 of 4 intrinsic subtypes and could allow determining the HER2 status.

This study was designed in order to define if such a test could help the oncologist to define the better therapeutic decision in a HER2 equivocal population. In addition, concordance tests will be performed. The aim of this study is to assess the modification decision rate between the first and the second multidisciplinary decision-making meeting in HER2 equivocal patients using genomic testing.

status: Terminated

primary_purpose: Diagnostic

lead_sponsor: Centre Jean Perrin

location_facility:
Institut Claudius Regaud
Institut Bergonie
Centre Georges François Leclerc
CHRU Jean Minoz
Institut Jean Godinot
Centre Paul Strauss
Institut Paoli Calmettes
Centre Jean Perrin
Institut de Cancérologie de l'Ouest
Institut de Cancérologie de Lorraine
Centre Léon Bérard
CHU Albert Michalon
Hopital DUPUYTREN
Institut de Cancérologie de Montpellier
Centre François Baclesse
Institut du Cancer COURLANCY

intervention_type: Diagnostic Test

status_simplified: Unknown


title: Improvement of Intraoperative Behavior of Staff to Prevent Postoperative Complications

summary: The aim of this interventional study is to optimize the movements and discipline of surgical staff in order to improve the quality of care, the safety of the patient in the surgery and to prevent the postoperative complications in the broad sense and in particular the infection of the surgical site. The intervention will be carried out using tools of new technologies allowing the monitoring of the movements and the sound level associated with techniques of behavior change inspired by those used in the human and social sciences.

ReferenceCitation: Birgand G, Haudebourg T, Grammatico-Guillon L, Ferrand L, Moret L, Gouin F, Mauduit N, Leux C, Le Manach Y, Lepelletier D, Tavernier E, Lucet JC, Giraudeau B. Improvement in staff behavior during surgical procedures to prevent post-operative complications (ARIBO(2)): study protocol for a cluster randomised trial. Trials. 2019 May 20;20(1):275. doi: 10.1186/s13063-019-3370-z.

lead_sponsor: Nantes University Hospital

location_facility:
IMM
Saint Grégoire private hospital
Vannes Hospital
Vendée Hospital
Saint-Nazaire Hospital
Hôpital Lariboisière
Tours University Hospital
Saint-Léonard Clinic
Pré surgical clinic
Hôpital Beaujon
Rennes University Hospital
Le Mans Hospital
Angers University Hospital
H.P. Confluent
Sante Atlantique
Nantes University Hospital

intervention_type: Other


acronym: ATALK

title: An Open-Label, Multicenter, Single-Arm, Phase II Study to Assess the Efficacy and Safety of Alectinib in Patients With ALK-Rearranged Non-Small Cell Lung Cancer After Disease Progression on Prior ALK Inhibitor Therapy

lead_sponsor: Hoffmann-La Roche

location_facility: CHRU Lille Service de Pneumologie et Oncologie Thoracique

location_facility: Centre Hospitalier Intercommunal; Service de Pneumologie

location_facility: Hopital Augustin Morvan; Oncologie Thoracique

location_facility: Hopital de Pontchaillou; Service de Pneumologie

location_facility: CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique

summary: This study will evaluate the efficacy and safety of alectinib, in selected participants, with anaplastic lymphoma kinase-rearranged (ALK-rearranged) non-small cell lung cancer (NSCLC), after disease progression on prior treatment strategy with crizotinib, as only ALK inhibitor, and eventually chemotherapy treatment(s).


title: Two Part (Double-blind Inclisiran Versus Placebo [Year 1] Followed by Open-label Inclisiran [Year 2]) Randomized Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Inclisiran in Adolescents (12 to Less Than 18 Years) With Heterozygous Familial Hypercholesterolemia and Elevated LDL-cholesterol (ORION-16)

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Reijman MD, Schweizer A, Peterson ALH, Bruckert E, Stratz C, Defesche JC, Hegele RA, Wiegman A. Rationale and design of two trials assessing the efficacy, safety, and tolerability of inclisiran in adolescents with homozygous and heterozygous familial hypercholesterolaemia. Eur J Prev Cardiol. 2022 Jul 20;29(9):1361-1368. doi: 10.1093/eurjpc/zwac025.

ReferenceCitation: Warden BA, Duell PB. Inclisiran: A Novel Agent for Lowering Apolipoprotein B-containing Lipoproteins. J Cardiovasc Pharmacol. 2021 Aug 1;78(2):e157-e174. doi: 10.1097/FJC.0000000000001053.

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

location_country:
Croatia
Spain
Italy
United Kingdom
United States
South Africa
Czechia
Poland
Slovenia
Russian Federation
Australia
Argentina
Israel
Turkey
Norway
Malaysia
Singapore
Slovakia
Brazil
Lebanon
Canada
Switzerland
Hungary
Germany
Taiwan
Jordan
Greece
Thailand
Vietnam
France
Netherlands

location_facility: Unidade de pesquisa clinica - Hospital Universitario Walter Cantidio

location_facility: Washington University School of Medicine

location_facility: Nucleo de Pesquisa Clinica do Rio Grande do Sul

location_facility: Lipids Center Sheba Medical Center, Israel

location_facility: University Medical Centre Ljubljana, Div. of Pediatric Dept. of Endocrinology, Diabetes and Metabolic Diseases

location_facility: University of Tennessee Health Science Center

location_facility: Hippokrateion General Hospital of Athens Greece

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Setor de Lípides, Aterosclerose e Biologia

location_facility: American University of Beirut Medical Center

location_facility: Research Institute for Complex Issues of Cardiovascular Disease

location_facility: Hippokratiou Hospital, Thessaloniki, Greece

summary: This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDL-C).


title: An Open-label, Randomised, Parallel-group, Multicentre, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less Than 18 Years of Age With Cardiac Diseases at Risk of Thromboembolic Events

lead_sponsor: Daiichi Sankyo, Inc.

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/

location_country:
Croatia
Spain
United Kingdom
Austria
Lebanon
Canada
Ukraine
Hungary
United States
France
India
Israel
Turkey
Egypt

location_facility: Wake Forest University Baptist Medical Center

location_facility: Erciyes University Medical Faculty, Department of Children Hospital

location_facility: McGill University Health Centre/Glen Site/Montreal Children's Hospital

location_facility: Kepler Universitätsklinikum Med Campus IV

location_facility: Novant Health Heart and Vascular institute

location_facility: Communal Institution Dnipropetrovsk Regional Pediatric Clinical Hospital of Dnipropetrovsk Regional Council, State Institution Dnipropetrovsk Medical Academy of MoH of Ukraine

location_facility: Vynnitsa Regional Children Clinical Hospital Policlinic Dept

location_facility: University of Florida College of Medicine

location_facility: Ege University Faculty of Medicine Department of Child Health and Diseases

location_facility: Pediatric and Congenital Cardiology and Pulmonology Department; Arnaud De Villeneuve University Hospital

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: Gottsegen Gyorgy Orszagos Kardiologiai Intezet

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Kasr Elainy School of Medicine, Abo Elreesh Hospital (Japanese Hospital), Ali Basha Ibrahim ST Faculty of Medicine Cairo University

location_facility: Izmir-Dr. Behçet Uz. Pediatric Diseases and Surgery Training and Research Hospital- Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi

location_facility: Pediatric Cardiology Department, Hospital Necker Enfants Malades, APHP, Université Paris Descartes

location_facility: University of California-San Francisco Department of Pediatrics - Hematology/Oncology

location_facility: Alexandria Clinical Research Center, Faculty of Medicine

location_facility: Children's Heart Centre at the American University of Beirut Medical Center

location_facility: Communal Healthcare Institution Regional Pediatric Clinical Hospital, Kharkiv National Medical University

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

summary:
A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care).

All children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots.

The study will find out if edoxaban is safer and more effective than the standard of care.


acronym: ALPINE

title: Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Pediatric Patients With Cystic Fibrosis (CF) and New Onset Lower Respiratory Tract Culture Positive for Pseudomonas Aeruginosa (PA)

lead_sponsor: Gilead Sciences

ReferenceCitation: Tiddens HA, De Boeck K, Clancy JP, Fayon M, H G M A, Bresnik M, Derchak A, Lewis SA, Oermann CM; ALPINE study investigators. Open label study of inhaled aztreonam for Pseudomonas eradication in children with cystic fibrosis: The ALPINE study. J Cyst Fibros. 2015 Jan;14(1):111-9. doi: 10.1016/j.jcf.2014.06.003. Epub 2014 Aug 1.

location_country:
Poland
Spain
Italy
Austria
Netherlands
United States
France
Belgium
Germany

location_facility: Centre hospitalier Robert Bissons CRCM - service pédiatrie

location_facility: Fondazione IRCCS, Ospedale Pediatrico, Bambino Gesu' di Roma

location_facility: Hôpital Universitaire des Enfants Reine Fabiola Brussels

location_facility: Universitätsklinikum Essen, Zentrum für Kinderheilkunde - Abteilung Allg. Kinderheilkunde/Neuropaediatrie

location_facility: Division of Respiratory Medicine and Allergology, Department of Pediatrics, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands

location_facility: Service pédiatrie II Hôpital Necker Enfants Malades

location_facility: Charité Campus Virchow Klinikum, Universitätsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunolgie Prof. Wahn

location_facility: Hospital Vall D' Hebron Pediatric Pneunmonology and Cystic Fibrosis Clinic

location_facility: Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem, Poradnia Leczenia Mukowiscydozy

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Instytut Matki i Dziecka Klinika Pediatrii

location_facility: Klinik fur Kinder- und Jugendmedizinim St Josef-Hopsital

location_facility: Pediatric Pulmonology, Dept Pediatrics University Hospital Gasthuisberg

location_facility: Instytut Gruźlicy i Chorób Płuc, Klinki Pneumologii i Mukowiscydozy

location_facility: Medizinische Universität Innsbruck Abt. für Kinder- und Jugendheilkunde, Pädiatrie III (Zystische Fibrose)

location_facility: Azienda Ospedaliero-Universitaria di Catania, Dipartimento di Pediatria, UO Broncopneumologia Pediatrica

location_facility: Hospital infantil Universitario Niño Jesus, Servicio de Neumología Pediatrica

location_facility: Centre de Ressources et de Compétences sur la Mucoviscidose ( CRCM), Roscoff, France

location_facility: Paediatrics, University Hospital Brussels (UZB)

location_facility: CHU de Boredaux Hôpital des Enfants - Pellegrin CEDRE

location_facility: PennState Milton S. Hershey Medical Center

location_facility: Hospital Materno-Infantil Carlos Haya, Servicio de Neumología Pediatrica

location_facility: Christiane Herzog CF-Center, Goethe University Hospital

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: Cystic Fibrosis Centre Paediatric Department, A. Meyer Children Hospital Florence

location_facility: Longziekten Universitair Medisch (PEDIATRIC), Ultrecht

location_facility: Universitaetsklinikum Bonn-Zentrum fuer Kinderheikunde

location_facility: Toledo Children's Hospital CF Research Center

location_facility: Centro Fibrosi Cistica di Verona, Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Pediatric Respiratory Department, Ghent University Hospital

summary:
This is an open-label, multi-center study in pediatric patients age 3 months to less than 18 years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary colonization/infection. All eligible participants will be treated with a 28-day course of Aztreonam for Inhalation Solution (AZLI) 75 mg 3 times daily. After completion of study drug, subjects will be followed up through Day 196 for safety and recurrence of PA.

The primary objective is to evaluate the proportion of participants with PA-negative cultures at all time points during a 6-month monitoring period (through Day 196) after cessation of AZLI treatment. Microbiological cultures will be obtained at Baseline, Day 28 (end of AZLI treatment), Day 56 (1 month after completing AZLI treatment), Day 112 (3 months after completing AZLI treatment), and Day 196 (6 months after completing AZLI treatment).


title: A Phase 2 BIOmarker Driven Trial With Nivolumab and Ipilimumab or VEGFR tKi in Naïve Metastatic Kidney Cancer

acronym: BIONIKK

summary:
Disease and Stage: naïve metastatic kidney cancer.

A multicenter, randomized, a Phase 2 BIOmarker driven trial with Nivolumab and Ipilimumab or VEGFR tKi in naïve metastatic Kidney cancer

ReferenceCitation: Vano YA, Elaidi R, Bennamoun M, Chevreau C, Borchiellini D, Pannier D, Maillet D, Gross-Goupil M, Tournigand C, Laguerre B, Barthélémy P, Coquan E, Gravis G, Houede N, Cancel M, Huillard O, Beuzeboc P, Fournier L, Méjean A, Cathelineau X, Doumerc N, Paparel P, Bernhard JC, de la Taille A, Bensalah K, Tricard T, Waeckel T, Pignot G, Braychenko E, Caruso S, Sun CM, Verkarre V, Lacroix G, Moreira M, Meylan M, Bougouïn A, Phan L, Thibault-Carpentier C, Zucman-Rossi J, Fridman WH, Sautès-Fridman C, Oudard S. Nivolumab, nivolumab-ipilimumab, and VEGFR-tyrosine kinase inhibitors as first-line treatment for metastatic clear-cell renal cell carcinoma (BIONIKK): a biomarker-driven, open-label, non-comparative, randomised, phase 2 trial. Lancet Oncol. 2022 May;23(5):612-624. doi: 10.1016/S1470-2045(22)00128-0. Epub 2022 Apr 4.

ReferenceCitation: Epaillard N, Simonaggio A, Elaidi R, Azzouz F, Braychenko E, Thibault C, Sun CM, Moreira M, Oudard S, Vano YA. BIONIKK: A phase 2 biomarker driven trial with nivolumab and ipilimumab or VEGFR tyrosine kinase inhibitor (TKI) in naïve metastatic kidney cancer. Bull Cancer. 2020 Jun;107(5S):eS22-eS27. doi: 10.1016/S0007-4551(20)30283-6.

lead_sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

location_facility: Institut de Cancérologie du Gard - CHU Caremeau

location_facility: Centre Hospitalier Lyon Sud - Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL)


title: EURECA (EUropeanRElapseCAlprotectin) Study - Calprotectin as Prediction Marker of Relapse in Patients With Quiescent Ulcerative Colitis

summary: This study will investigate the correlation of fecal calprotectin (FC) values to quiescent ulcerative colitis and to disease activity (relapse) as assessed by clinical data and endoscopy.

ReferenceCitation: Fiorino G, Danese S, Peyrin-Biroulet L, Sans M, Bonelli F, Calleri M, Zierold C, Pollastro R, Moretti F, Malesci A. LIAISON(®) Calprotectin for the prediction of relapse in quiescent ulcerative colitis: The EuReCa study. United European Gastroenterol J. 2022 Oct;10(8):836-843. doi: 10.1002/ueg2.12268. Epub 2022 Jul 4.

lead_sponsor: DiaSorin Inc.

location_country: France Spain Italy

location_facility: Centro Médico Teknon Gastroenterologia Adultos

location_facility: Centre Hospitalier Universitaire De Nancy (CHU de Nancy) Department Gastroenterology

location_facility: Istituto Clinico Humanitas Centro IBD Diparimento di Gastroenterologia


title: Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation. The PREVENTION Randomized Multicenter Study

acronym: PREVENTION

summary: Tracheal intubation (TI) is associated with a high risk of adverse events in critically ill patients and peri-intubation hemodynamic collapse is the most commonly observed. The primary aim of the PREVENTION trial is to compare the effect of the pre-emptive use of noradrenaline versus no peri-intubation use of noradrenaline on incidence of cardiovascular collapse following TI in adult critically ill patients. Patients with absolute indication or contraindication to vasopressor support will be excluded from this trial. Patients will be randomized 1:1 to a continuous infusion of noradrenaline started before induction titrated to the goal of MAP 100 mmHg. The primary outcome will be the incidence of cardiovascular collapse. Secondary outcomes will include lowest systolic blood pressure within 30 minutes, ICU and in-hospital mortality.

study_start_date_type: Anticipated

status: Not yet recruiting

ReferenceType: result

ReferenceCitation: Russotto V, Myatra SN, Laffey JG, Tassistro E, Antolini L, Bauer P, Lascarrou JB, Szuldrzynski K, Camporota L, Pelosi P, Sorbello M, Higgs A, Greif R, Putensen C, Agvald-Öhman C, Chalkias A, Bokums K, Brewster D, Rossi E, Fumagalli R, Pesenti A, Foti G, Bellani G; INTUBE Study Investigators. Intubation Practices and Adverse Peri-intubation Events in Critically Ill Patients From 29 Countries. JAMA. 2021 Mar 23;325(12):1164-1172. doi: 10.1001/jama.2021.1727. Erratum in: JAMA. 2021 May 24;:null.

ReferenceCitation: Russotto V, Myatra SN, Laffey JG. What's new in airway management of the critically ill. Intensive Care Med. 2019 Nov;45(11):1615-1618. doi: 10.1007/s00134-019-05757-0. Epub 2019 Sep 16.

ReferenceCitation: Janz DR, Casey JD, Semler MW, Russell DW, Dargin J, Vonderhaar DJ, Dischert KM, West JR, Stempek S, Wozniak J, Caputo N, Heideman BE, Zouk AN, Gulati S, Stigler WS, Bentov I, Joffe AM, Rice TW; PrePARE Investigators; Pragmatic Critical Care Research Group. Effect of a fluid bolus on cardiovascular collapse among critically ill adults undergoing tracheal intubation (PrePARE): a randomised controlled trial. Lancet Respir Med. 2019 Dec;7(12):1039-1047. doi: 10.1016/S2213-2600(19)30246-2. Epub 2019 Oct 1.

lead_sponsor: Azienda Ospedaliera San Gerardo di Monza

location_country: France Italy Ireland

location_facility:
CHU de Nantes
Galway University Hospitals
University Hospital San Gerardo


acronym: REGOLD

title: Phase II Study Evaluating the Efficacy and the Safety of Regorafenib in Patients Aged More Than 70 Years Old With a Metastatic Colorectal Adenocarcinoma .

lead_sponsor: Federation Francophone de Cancerologie Digestive

ReferenceCitation: Aparicio T, Darut-Jouve A, Khemissa Akouz F, Montérymard C, Artru P, Cany L, Romano O, Valenza B, Le Foll C, Delbaldo C, Falandry C, Norguet Monnereau E, Ben Abdelghani M, Smith D, Rinaldi Y, Père Verge D, Baize N, Maillard E, Dohan A, Des Guetz G, Pamoukdjian F, Lepage C. Single-arm phase II trial to evaluate efficacy and tolerance of regorafenib monotherapy in patients over 70 with previously treated metastatic colorectal adenocarcinoma FFCD 1404 - REGOLD. J Geriatr Oncol. 2020 Nov;11(8):1255-1262. doi: 10.1016/j.jgo.2020.04.001. Epub 2020 Apr 22.

location_facility: Caluire et Cuire - Infirmerie Protestante de Lyon

summary: Multicenter prospective phase II study evaluating regorafenib in older patients with metastatic colorectal cancer


acronym: BISPHOO

intervention_type: Device

title: Non-inferiority Trial of Three Cycles of Zoledronic Acid Versus Percutaneous Thermal Ablation in Osteoid Osteoma

lead_sponsor: Assistance Publique - Hôpitaux de Paris

location_facility: Hôpital LARIBOSISIERE - Service radiologie ostéo-articulaire

location_facility: Hôpital ROGER SALENGRO - Service d'Orthopédie A

location_facility: Hôpital LAPEYRONIE - Service Rhumatologie

location_facility: Hôpital LARIBOSISIERE - Service rhumatologie

location_facility: Hôpital ROGER SALENGRO - Radiologie et imagerie musculo-squelettique

location_facility: Hopital PELLEGRIN - Service d'imagerie diagnostique et interventionnelle de l'adulte

location_facility: Hopital PELLEGRIN - Service rhumatologie

summary: Osteoid osteoma (OO) is a benign osteogenic tumor occurring in children and young adults, responsible for intense bone pain, which has a tendency to spontaneously heal with mineralization of the nidus, but extremely slowly. This healing may be accelerated in patients taking NSAIDs regularly during a few years. The long delay for healing and intense pain, explain why patients are quickly directed to surgeons or specialized radiology departments for tumor ablation. But percutaneous treatment or surgical excision destruction can expose the patient to a substantial risk in terms of neurologic or joint damages, depending on the location. Bisphosphonates treatment may be an effective alternative to percutaneous treatment by accelerating the natural history of OO.


type: Other Identifier

title: EVRIOS : Comparative Evaluation of Low Versus High Doses of Rifampicin in the Treatment of Staphylococcal Bone and Joint Infections

acronym: EVRIOS

summary:
Rifampicin is an antibiotic usually required to treat susceptible Staphylococcus spp. osteo-articular infections, most frequently in association with a fluoroquinolone when the strain is susceptible to both agents. It is the reference treatment for orthopedic infections with implanted material.

For tuberculosis treatment the dosage of 10 mg/kg/j is usually prescribed, while in the treatment of Staphylococcus spp. infections the highest dosage of 20 mg/kg/j is proposed by French experts' recommendations from 2009.

However, there is little evidence in the literature, which could set out arguments to choose the best dosage of rifampicin, which may vary from 5 to 20 mg/kg.

The issue with rifampicin is side effects, in particular with long-term treatment. Many side effects may occur in 10 to 20% of patients and sometimes leads to dosage reduction or treatment interruption.

In the literature, there is little evidence that higher rifampicin dosage is associated with higher frequency of adverse effects. Depending on the nature of the toxicity, one could say that hypersensitivity could be independent from dosage, when digestive disorders may be related. Plasmatic concentrations studies have not given strong arguments to link higher rifampicin dosages with side effects occurrence rates. After oral absorption, plasmatic peak occurs after two to five hours and varies among individuals but also in the same patient overtime. This particular pharmacokinetic profile could explain discrepancy in adverse events (AEs) frequencies.

lead_sponsor: Rennes University Hospital

location_facility:
Pau hospital
Angers university hospital
Bordeaux university hospital
Caen university hospital
La Roche sur Yon hospital
Saint-Malo hospital
Lorient hospital
Nantes university hospital
Rennes university hospital
Toulouse university hospital
Brest university hospital
Vannes hospital
Poitiers university hospital
Tours university hospital
Saint-Brieuc hospital
Clinique du Parc et Hôpital Jean Mermoz


title: A Study of ABT-263 as Single Agent in Women With Platinum Resistant/Refractory Recurrent Ovarian Cancer

lead_sponsor: Centre Francois Baclesse

ReferenceCitation: Joly F, Fabbro M, Follana P, Lequesne J, Medioni J, Lesoin A, Frenel JS, Abadie-Lacourtoisie S, Floquet A, Gladieff L, You B, Gavoille C, Kalbacher E, Briand M, Brachet PE, Giffard F, Weiswald LB, Just PA, Blanc-Fournier C, Leconte A, Clarisse B, Leary A, Poulain L. A phase II study of Navitoclax (ABT-263) as single agent in women heavily pretreated for recurrent epithelial ovarian cancer: The MONAVI - GINECO study. Gynecol Oncol. 2022 Apr;165(1):30-39. doi: 10.1016/j.ygyno.2022.01.021. Epub 2022 Feb 2.

location_facility: ICL Institut de Cancérologie de Lorraine

summary: ABT-263 as single agent in women with platinum resistant/refractory recurrent ovarian cancer.


acronym: BRIDGE

intervention_type: Biological

title: BRIDGE Trial: Phase II Trial of durvalumaB and chemotheRapy Induction Followed by Durvalumab and Radiotherapy in larGe volumE Stage III NSCLC

lead_sponsor: Mario Negri Institute for Pharmacological Research

ReferenceType: background

ReferenceCitation: Alexandrov LB, Nik-Zainal S, Wedge DC, Aparicio SA, Behjati S, Biankin AV, Bignell GR, Bolli N, Borg A, Børresen-Dale AL, Boyault S, Burkhardt B, Butler AP, Caldas C, Davies HR, Desmedt C, Eils R, Eyfjörd JE, Foekens JA, Greaves M, Hosoda F, Hutter B, Ilicic T, Imbeaud S, Imielinski M, Jäger N, Jones DT, Jones D, Knappskog S, Kool M, Lakhani SR, López-Otín C, Martin S, Munshi NC, Nakamura H, Northcott PA, Pajic M, Papaemmanuil E, Paradiso A, Pearson JV, Puente XS, Raine K, Ramakrishna M, Richardson AL, Richter J, Rosenstiel P, Schlesner M, Schumacher TN, Span PN, Teague JW, Totoki Y, Tutt AN, Valdés-Mas R, van Buuren MM, van 't Veer L, Vincent-Salomon A, Waddell N, Yates LR; Australian Pancreatic Cancer Genome Initiative; ICGC Breast Cancer Consortium; ICGC MMML-Seq Consortium; ICGC PedBrain, Zucman-Rossi J, Futreal PA, McDermott U, Lichter P, Meyerson M, Grimmond SM, Siebert R, Campo E, Shibata T, Pfister SM, Campbell PJ, Stratton MR. Signatures of mutational processes in human cancer. Nature. 2013 Aug 22;500(7463):415-21. doi: 10.1038/nature12477. Epub 2013 Aug 14. Erratum in: Nature. 2013 Oct 10;502(7470):258. Imielinsk, Marcin [corrected to Imielinski, Marcin].

ReferenceCitation: Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeño J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Özgüroğlu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8.

ReferenceCitation: Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Kurata T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeño J, Faivre-Finn C, Reck M, Vansteenkiste J, Spigel DR, Wadsworth C, Melillo G, Taboada M, Dennis PA, Özgüroğlu M; PACIFIC Investigators. Overall Survival with Durvalumab after Chemoradiotherapy in Stage III NSCLC. N Engl J Med. 2018 Dec 13;379(24):2342-2350. doi: 10.1056/NEJMoa1809697. Epub 2018 Sep 25.

ReferenceCitation: Aupérin A, Le Péchoux C, Rolland E, Curran WJ, Furuse K, Fournel P, Belderbos J, Clamon G, Ulutin HC, Paulus R, Yamanaka T, Bozonnat MC, Uitterhoeve A, Wang X, Stewart L, Arriagada R, Burdett S, Pignon JP. Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer. J Clin Oncol. 2010 May 1;28(13):2181-90. doi: 10.1200/JCO.2009.26.2543. Epub 2010 Mar 29. Review.

ReferenceCitation: Bayman N, Blackhall F, McCloskey P, Taylor P, Faivre-Finn C. How can we optimise concurrent chemoradiotherapy for inoperable stage III non-small cell lung cancer? Lung Cancer. 2014 Feb;83(2):117-25. doi: 10.1016/j.lungcan.2013.11.017. Epub 2013 Dec 1. Review.

ReferenceCitation: Bracci L, Schiavoni G, Sistigu A, Belardelli F. Immune-based mechanisms of cytotoxic chemotherapy: implications for the design of novel and rationale-based combined treatments against cancer. Cell Death Differ. 2014 Jan;21(1):15-25. doi: 10.1038/cdd.2013.67. Epub 2013 Jun 21. Review.

ReferenceCitation: Bradley JD, Paulus R, Komaki R, Masters G, Blumenschein G, Schild S, Bogart J, Hu C, Forster K, Magliocco A, Kavadi V, Garces YI, Narayan S, Iyengar P, Robinson C, Wynn RB, Koprowski C, Meng J, Beitler J, Gaur R, Curran W Jr, Choy H. Standard-dose versus high-dose conformal radiotherapy with concurrent and consolidation carboplatin plus paclitaxel with or without cetuximab for patients with stage IIIA or IIIB non-small-cell lung cancer (RTOG 0617): a randomised, two-by-two factorial phase 3 study. Lancet Oncol. 2015 Feb;16(2):187-99. doi: 10.1016/S1470-2045(14)71207-0. Epub 2015 Jan 16.

ReferenceCitation: Brahmer JR, Tykodi SS, Chow LQ, Hwu WJ, Topalian SL, Hwu P, Drake CG, Camacho LH, Kauh J, Odunsi K, Pitot HC, Hamid O, Bhatia S, Martins R, Eaton K, Chen S, Salay TM, Alaparthy S, Grosso JF, Korman AJ, Parker SM, Agrawal S, Goldberg SM, Pardoll DM, Gupta A, Wigginton JM. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med. 2012 Jun 28;366(26):2455-65. doi: 10.1056/NEJMoa1200694. Epub 2012 Jun 2.

ReferenceCitation: Brahmer JR, Horn L, Gandhi L, Spigel DR, Antonia SJ, Rizvi NA, et al. Nivolumab (anti-PD-1, BMS-936558, ONO-4538) in patients (pts) with advanced non-small-cell lung cancer (NSCLC): Survival and clinical activity by subgroup analysis [ASCO abstract 8112]. J Clin Oncol 2014;32(Suppl)

ReferenceCitation: Brookmeyer R, Crowley J. A confidence interval for the median survival time. Biometrics 1982, 38, 29-41. doi:10.2307/2530286

ReferenceCitation: Butte MJ, Keir ME, Phamduy TB, Sharpe AH, Freeman GJ. Programmed death-1 ligand 1 interacts specifically with the B7-1 costimulatory molecule to inhibit T cell responses. Immunity. 2007 Jul;27(1):111-22. Epub 2007 Jul 12.

ReferenceCitation: De Ruysscher D, Reynders K, Van Limbergen E, Lambrecht M. Radiotherapy in combination with immune checkpoint inhibitors. Curr Opin Oncol. 2017 Mar;29(2):105-111. doi: 10.1097/CCO.0000000000000352. Review.

ReferenceCitation: De Ruysscher D, Faivre-Finn C, Moeller D, Nestle U, Hurkmans CW, Le Péchoux C, Belderbos J, Guckenberger M, Senan S; Lung Group and the Radiation Oncology Group of the European Organization for Research and Treatment of Cancer (EORTC). European Organization for Research and Treatment of Cancer (EORTC) recommendations for planning and delivery of high-dose, high precision radiotherapy for lung cancer. Radiother Oncol. 2017 Jul;124(1):1-10. doi: 10.1016/j.radonc.2017.06.003. Epub 2017 Jun 27.

ReferenceCitation: Drake CG, McDermott DF, Sznol M, Choueiri TK, Kluger HM, Powderly JD et al. Survival, safety, and response duration results of nivolumab (Anti-PD-1; BMS-936558; ONO-4538) in a phase I trial in patients with previously treated metastatic renal cell carcinoma (mRCC): Long-term patient follow-up [abstract 4514]. J Clin Oncol 2013;31(Suppl)

ReferenceCitation: Dunn GP, Old LJ, Schreiber RD. The three Es of cancer immunoediting. Annu Rev Immunol. 2004;22:329-60. Review.

ReferenceCitation: Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.

ReferenceCitation: Ellis S, Carroll KJ, Pemberton K. Analysis of duration of response in oncology trials. Contemp Clin Trials. 2008 Jul;29(4):456-65. doi: 10.1016/j.cct.2007.10.008. Epub 2007 Nov 12.

ReferenceCitation: Fairman D, Narwal R, Liang M, Robbins PB, Schneider A, Chavez C, et al. Pharmacokinetics of durvalumab, a fully human anti-PDL1 monoclonal antibody, in patients with advanced solid tumours. Journal of Clinical Oncology, 2014 ASCO Annual Meeting Abstracts;32(5s): (suppl; abstr 2602)

ReferenceCitation: Fife BT, Bluestone JA. Control of peripheral T-cell tolerance and autoimmunity via the CTLA-4 and PD-1 pathways. Immunol Rev. 2008 Aug;224:166-82. doi: 10.1111/j.1600-065X.2008.00662.x. Review.

ReferenceCitation: Forde PM, Chaft JE, Smith KN, Anagnostou V, Cottrell TR, Hellmann MD, Zahurak M, Yang SC, Jones DR, Broderick S, Battafarano RJ, Velez MJ, Rekhtman N, Olah Z, Naidoo J, Marrone KA, Verde F, Guo H, Zhang J, Caushi JX, Chan HY, Sidhom JW, Scharpf RB, White J, Gabrielson E, Wang H, Rosner GL, Rusch V, Wolchok JD, Merghoub T, Taube JM, Velculescu VE, Topalian SL, Brahmer JR, Pardoll DM. Neoadjuvant PD-1 Blockade in Resectable Lung Cancer. N Engl J Med. 2018 May 24;378(21):1976-1986. doi: 10.1056/NEJMoa1716078. Epub 2018 Apr 16. Erratum in: N Engl J Med. 2018 Nov 29;379(22):2185.

ReferenceCitation: Gagliardi G, Constine LS, Moiseenko V, Correa C, Pierce LJ, Allen AM, Marks LB. Radiation dose-volume effects in the heart. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3 Suppl):S77-85. doi: 10.1016/j.ijrobp.2009.04.093. Review.

ReferenceCitation: Gandhi L, Rodríguez-Abreu D, Gadgeel S, Esteban E, Felip E, De Angelis F, Domine M, Clingan P, Hochmair MJ, Powell SF, Cheng SY, Bischoff HG, Peled N, Grossi F, Jennens RR, Reck M, Hui R, Garon EB, Boyer M, Rubio-Viqueira B, Novello S, Kurata T, Gray JE, Vida J, Wei Z, Yang J, Raftopoulos H, Pietanza MC, Garassino MC; KEYNOTE-189 Investigators. Pembrolizumab plus Chemotherapy in Metastatic Non-Small-Cell Lung Cancer. N Engl J Med. 2018 May 31;378(22):2078-2092. doi: 10.1056/NEJMoa1801005. Epub 2018 Apr 16.

ReferenceCitation: Herbst RS, Gordon MS, Fine GD, Sosman JA, Soria JC, Hamid O, et al. A study of MPDL3280A, an engineered PD-L1 antibody in patients with locally advanced or metastatic tumours [abstract 3000]. J Clin Oncol 2013;31(Suppl 15)

ReferenceCitation: Hirano F, Kaneko K, Tamura H, Dong H, Wang S, Ichikawa M, Rietz C, Flies DB, Lau JS, Zhu G, Tamada K, Chen L. Blockade of B7-H1 and PD-1 by monoclonal antibodies potentiates cancer therapeutic immunity. Cancer Res. 2005 Feb 1;65(3):1089-96.

ReferenceCitation: Topalian SL, Sznol M, McDermott DF, Kluger HM, Carvajal RD, Sharfman WH, Brahmer JR, Lawrence DP, Atkins MB, Powderly JD, Leming PD, Lipson EJ, Puzanov I, Smith DC, Taube JM, Wigginton JM, Kollia GD, Gupta A, Pardoll DM, Sosman JA, Hodi FS. Survival, durable tumor remission, and long-term safety in patients with advanced melanoma receiving nivolumab. J Clin Oncol. 2014 Apr 1;32(10):1020-30. doi: 10.1200/JCO.2013.53.0105. Epub 2014 Mar 3.

ReferenceCitation: Iwai Y, Ishida M, Tanaka Y, Okazaki T, Honjo T, Minato N. Involvement of PD-L1 on tumor cells in the escape from host immune system and tumor immunotherapy by PD-L1 blockade. Proc Natl Acad Sci U S A. 2002 Sep 17;99(19):12293-7. Epub 2002 Sep 6.

ReferenceCitation: Keir ME, Butte MJ, Freeman GJ, Sharpe AH. PD-1 and its ligands in tolerance and immunity. Annu Rev Immunol. 2008;26:677-704. doi: 10.1146/annurev.immunol.26.021607.090331. Review.

ReferenceCitation: Kong FM, Ritter T, Quint DJ, Senan S, Gaspar LE, Komaki RU, Hurkmans CW, Timmerman R, Bezjak A, Bradley JD, Movsas B, Marsh L, Okunieff P, Choy H, Curran WJ Jr. Consideration of dose limits for organs at risk of thoracic radiotherapy: atlas for lung, proximal bronchial tree, esophagus, spinal cord, ribs, and brachial plexus. Int J Radiat Oncol Biol Phys. 2011 Dec 1;81(5):1442-57. doi: 10.1016/j.ijrobp.2010.07.1977. Epub 2010 Oct 8.

ReferenceCitation: Lan KKG, DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika 1983;70:659-63

ReferenceCitation: Lesterhuis WJ, Punt CJ, Hato SV, Eleveld-Trancikova D, Jansen BJ, Nierkens S, Schreibelt G, de Boer A, Van Herpen CM, Kaanders JH, van Krieken JH, Adema GJ, Figdor CG, de Vries IJ. Platinum-based drugs disrupt STAT6-mediated suppression of immune responses against cancer in humans and mice. J Clin Invest. 2011 Aug;121(8):3100-8. doi: 10.1172/JCI43656. Epub 2011 Jul 18.

ReferenceCitation: Lin SH, Lin Y, Price J, Parker M, et al. DETERRED: PD-L1 blockade to evaluate the safety of lung cancer therapy using carboplatin, paclitaxel, and radiation combined with MPDL3280A (atezolizumab). Journal of Clinical Oncology 2017 35:15_suppl, 3064-3064

ReferenceCitation: Marks LB, Yorke ED, Jackson A, Ten Haken RK, Constine LS, Eisbruch A, Bentzen SM, Nam J, Deasy JO. Use of normal tissue complication probability models in the clinic. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3 Suppl):S10-9. doi: 10.1016/j.ijrobp.2009.07.1754.

ReferenceCitation: Marks LB, Bentzen SM, Deasy JO, Kong FM, Bradley JD, Vogelius IS, El Naqa I, Hubbs JL, Lebesque JV, Timmerman RD, Martel MK, Jackson A. Radiation dose-volume effects in the lung. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3 Suppl):S70-6. doi: 10.1016/j.ijrobp.2009.06.091. Review.

ReferenceCitation: Narwal R, Roskos LK, Robbie GJ. Population pharmacokinetics of sifalimumab, an investigational anti-interferon-α monoclonal antibody, in systemic lupus erythematosus. Clin Pharmacokinet. 2013 Nov;52(11):1017-27. doi: 10.1007/s40262-013-0085-2.

ReferenceCitation: Nestle U, De Ruysscher D, Ricardi U, Geets X, Belderbos J, Pöttgen C, Dziadiuszko R, Peeters S, Lievens Y, Hurkmans C, Slotman B, Ramella S, Faivre-Finn C, McDonald F, Manapov F, Putora PM, LePéchoux C, Van Houtte P. ESTRO ACROP guidelines for target volume definition in the treatment of locally advanced non-small cell lung cancer. Radiother Oncol. 2018 Apr;127(1):1-5. doi: 10.1016/j.radonc.2018.02.023. Epub 2018 Mar 28.

ReferenceCitation: Ng CM, Lum BL, Gimenez V, Kelsey S, Allison D. Rationale for fixed dosing of pertuzumab in cancer patients based on population pharmacokinetic analysis. Pharm Res. 2006 Jun;23(6):1275-84. Epub 2006 May 26.

ReferenceCitation: Okudaira K, Hokari R, Tsuzuki Y, Okada Y, Komoto S, Watanabe C, Kurihara C, Kawaguchi A, Nagao S, Azuma M, Yagita H, Miura S. Blockade of B7-H1 or B7-DC induces an anti-tumor effect in a mouse pancreatic cancer model. Int J Oncol. 2009 Oct;35(4):741-9.

ReferenceCitation: Pardoll DM. The blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer. 2012 Mar 22;12(4):252-64. doi: 10.1038/nrc3239. Review.

ReferenceCitation: Paterson AM, Brown KE, Keir ME, Vanguri VK, Riella LV, Chandraker A, Sayegh MH, Blazar BR, Freeman GJ, Sharpe AH. The programmed death-1 ligand 1:B7-1 pathway restrains diabetogenic effector T cells in vivo. J Immunol. 2011 Aug 1;187(3):1097-105. doi: 10.4049/jimmunol.1003496. Epub 2011 Jun 22.

ReferenceCitation: Paz-Ares L, Luft A, Vicente D, Tafreshi A, Gümüş M, Mazières J, Hermes B, Çay Şenler F, Csőszi T, Fülöp A, Rodríguez-Cid J, Wilson J, Sugawara S, Kato T, Lee KH, Cheng Y, Novello S, Halmos B, Li X, Lubiniecki GM, Piperdi B, Kowalski DM; KEYNOTE-407 Investigators. Pembrolizumab plus Chemotherapy for Squamous Non-Small-Cell Lung Cancer. N Engl J Med. 2018 Nov 22;379(21):2040-2051. doi: 10.1056/NEJMoa1810865. Epub 2018 Sep 25.

ReferenceCitation: Peters S, De Ruysscher D, Dafni U, et al. Safety evaluation of nivolumab added concurrently to radiotherapy in a standard first line chemo-RT regimen in unresectable locally advanced NSCLC: The ETOP NICOLAS phase II trial. J Clin Oncol 36, 2018 (suppl; abstr 8510)

ReferenceCitation: Powles T, Eder JP, Fine GD, Braiteh FS, Loriot Y, Cruz C, Bellmunt J, Burris HA, Petrylak DP, Teng SL, Shen X, Boyd Z, Hegde PS, Chen DS, Vogelzang NJ. MPDL3280A (anti-PD-L1) treatment leads to clinical activity in metastatic bladder cancer. Nature. 2014 Nov 27;515(7528):558-62. doi: 10.1038/nature13904.

ReferenceCitation: Rizvi N, Brahmer J, Ou S-H, Segal NH, Khleif SN, Hwu WJ. Safety and clinical activity of MEDI4736, an anti-programmed cell death-ligand-1 (PD-L1) antibody, in patients with nonsmall cell lung cancer (NSCLC). J Clin Oncol 2015;33:Abstract 8032

ReferenceCitation: Roselli M, Cereda V, di Bari MG, Formica V, Spila A, Jochems C, Farsaci B, Donahue R, Gulley JL, Schlom J, Guadagni F. Effects of conventional therapeutic interventions on the number and function of regulatory T cells. Oncoimmunology. 2013 Oct 1;2(10):e27025.

ReferenceCitation: Schadendorf D, Hodi FS, Robert C et al. Pooled analysis of long-term survival data from phase II and phase III trials of ipilimumab in metastatic or locally advanced, unresectable melanoma [abstract 24]. Presented at European Cancer Congress 2013 (ECCO-ESMO-ESTRO); 27 September to 01 October 2013; Amsterdam, The Netherlands

ReferenceCitation: Segal NH, Ou S-HI, Balmanoukian AS, Fury MG, Massarelli E, Brahmer JR, et al. Safety and efficacy of MEDI4736, an anti-PD-L1 antibody, in patients from a squamous cell carcinoma of the head and neck (SCCHN) expansion cohort. J Clin Oncol 2015;33:Abstract 3011

ReferenceCitation: Senan S, Brade A, Wang LH, Vansteenkiste J, Dakhil S, Biesma B, Martinez Aguillo M, Aerts J, Govindan R, Rubio-Viqueira B, Lewanski C, Gandara D, Choy H, Mok T, Hossain A, Iscoe N, Treat J, Koustenis A, San Antonio B, Chouaki N, Vokes E. PROCLAIM: Randomized Phase III Trial of Pemetrexed-Cisplatin or Etoposide-Cisplatin Plus Thoracic Radiation Therapy Followed by Consolidation Chemotherapy in Locally Advanced Nonsquamous Non-Small-Cell Lung Cancer. J Clin Oncol. 2016 Mar 20;34(9):953-62. doi: 10.1200/JCO.2015.64.8824. Epub 2016 Jan 25.

ReferenceCitation: Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10.

ReferenceCitation: Socinski MA, Jotte RM, Cappuzzo F, Orlandi F, Stroyakovskiy D, Nogami N, Rodríguez-Abreu D, Moro-Sibilot D, Thomas CA, Barlesi F, Finley G, Kelsch C, Lee A, Coleman S, Deng Y, Shen Y, Kowanetz M, Lopez-Chavez A, Sandler A, Reck M; IMpower150 Study Group. Atezolizumab for First-Line Treatment of Metastatic Nonsquamous NSCLC. N Engl J Med. 2018 Jun 14;378(24):2288-2301. doi: 10.1056/NEJMoa1716948. Epub 2018 Jun 4.

ReferenceCitation: Steuer CE, Behera M, Ernani V, Higgins KA, Saba NF, Shin DM, Pakkala S, Pillai RN, Owonikoko TK, Curran WJ, Belani CP, Khuri FR, Ramalingam SS. Comparison of Concurrent Use of Thoracic Radiation With Either Carboplatin-Paclitaxel or Cisplatin-Etoposide for Patients With Stage III Non-Small-Cell Lung Cancer: A Systematic Review. JAMA Oncol. 2017 Aug 1;3(8):1120-1129. doi: 10.1001/jamaoncol.2016.4280. Review.

ReferenceCitation: Stewart R, Morrow M, Hammond SA, Mulgrew K, Marcus D, Poon E, Watkins A, Mullins S, Chodorge M, Andrews J, Bannister D, Dick E, Crawford N, Parmentier J, Alimzhanov M, Babcook JS, Foltz IN, Buchanan A, Bedian V, Wilkinson RW, McCourt M. Identification and Characterization of MEDI4736, an Antagonistic Anti-PD-L1 Monoclonal Antibody. Cancer Immunol Res. 2015 Sep;3(9):1052-62. doi: 10.1158/2326-6066.CIR-14-0191. Epub 2015 May 5.

ReferenceCitation: Tarhini AA, Kirkwood JM. Tremelimumab (CP-675,206): a fully human anticytotoxic T lymphocyte-associated antigen 4 monoclonal antibody for treatment of patients with advanced cancers. Expert Opin Biol Ther. 2008 Oct;8(10):1583-93. doi: 10.1517/14712598.8.10.1583 .

ReferenceCitation: Topalian SL, Hodi FS, Brahmer JR, Gettinger SN, Smith DC, McDermott DF, Powderly JD, Carvajal RD, Sosman JA, Atkins MB, Leming PD, Spigel DR, Antonia SJ, Horn L, Drake CG, Pardoll DM, Chen L, Sharfman WH, Anders RA, Taube JM, McMiller TL, Xu H, Korman AJ, Jure-Kunkel M, Agrawal S, McDonald D, Kollia GD, Gupta A, Wigginton JM, Sznol M. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med. 2012 Jun 28;366(26):2443-54. doi: 10.1056/NEJMoa1200690. Epub 2012 Jun 2.

ReferenceCitation: Tsujino K, Kurata T, Yamamoto S, Kawaguchi T, Kubo A, Isa S, Hasegawa Y, Ou SH, Takada M, Ando M. Is consolidation chemotherapy after concurrent chemo-radiotherapy beneficial for patients with locally advanced non-small-cell lung cancer? A pooled analysis of the literature. J Thorac Oncol. 2013 Sep;8(9):1181-9. doi: 10.1097/JTO.0b013e3182988348.

ReferenceCitation: Wang DD, Zhang S, Zhao H, Men AY, Parivar K. Fixed dosing versus body size-based dosing of monoclonal antibodies in adult clinical trials. J Clin Pharmacol. 2009 Sep;49(9):1012-24. doi: 10.1177/0091270009337512. Epub 2009 Jul 20.

ReferenceCitation: Wang E, Kang D, Bae KS, Marshall MA, Pavlov D, Parivar K. Population pharmacokinetic and pharmacodynamic analysis of tremelimumab in patients with metastatic melanoma. J Clin Pharmacol. 2014 Oct;54(10):1108-16. doi: 10.1002/jcph.309. Epub 2014 Apr 23.

ReferenceCitation: Wang Z, Till B, Gao Q. Chemotherapeutic agent-mediated elimination of myeloid-derived suppressor cells. Oncoimmunology. 2017 Jun 16;6(7):e1331807. doi: 10.1080/2162402X.2017.1331807. eCollection 2017. Review.

ReferenceCitation: Wang K, Eblan MJ, Deal AM, Lipner M, Zagar TM, Wang Y, Mavroidis P, Lee CB, Jensen BC, Rosenman JG, Socinski MA, Stinchcombe TE, Marks LB. Cardiac Toxicity After Radiotherapy for Stage III Non-Small-Cell Lung Cancer: Pooled Analysis of Dose-Escalation Trials Delivering 70 to 90 Gy. J Clin Oncol. 2017 May 1;35(13):1387-1394. doi: 10.1200/JCO.2016.70.0229. Epub 2017 Jan 23.

ReferenceCitation: Wiens BL. A fixed sequence Bonferroni procedure for testing multiple endpoints Pharmaceut. Statist. 2003; 2: 211-215

ReferenceCitation: Wolchok JD, Kluger H, Callahan MK, Postow MA, Rizvi NA, Lesokhin AM, Segal NH, Ariyan CE, Gordon RA, Reed K, Burke MM, Caldwell A, Kronenberg SA, Agunwamba BU, Zhang X, Lowy I, Inzunza HD, Feely W, Horak CE, Hong Q, Korman AJ, Wigginton JM, Gupta A, Sznol M. Nivolumab plus ipilimumab in advanced melanoma. N Engl J Med. 2013 Jul 11;369(2):122-33. doi: 10.1056/NEJMoa1302369. Epub 2013 Jun 2. Erratum in: N Engl J Med. 2018 Nov 29;379(22):2185.

ReferenceCitation: Yuan J, Adamow M, Ginsberg BA, Rasalan TS, Ritter E, Gallardo HF, Xu Y, Pogoriler E, Terzulli SL, Kuk D, Panageas KS, Ritter G, Sznol M, Halaban R, Jungbluth AA, Allison JP, Old LJ, Wolchok JD, Gnjatic S. Integrated NY-ESO-1 antibody and CD8+ T-cell responses correlate with clinical benefit in advanced melanoma patients treated with ipilimumab. Proc Natl Acad Sci U S A. 2011 Oct 4;108(40):16723-8. doi: 10.1073/pnas.1110814108. Epub 2011 Sep 20.

ReferenceCitation: Zhang C, Wu S, Xue X, Li M, Qin X, Li W, Han W, Zhang Y. Anti-tumor immunotherapy by blockade of the PD-1/PD-L1 pathway with recombinant human PD-1-IgV. Cytotherapy. 2008;10(7):711-9. doi: 10.1080/14653240802320237.

ReferenceCitation: Zhang S, Shi R, Li C, Parivar K, Wang DD. Fixed dosing versus body size-based dosing of therapeutic peptides and proteins in adults. J Clin Pharmacol. 2012 Jan;52(1):18-28. doi: 10.1177/0091270010388648. Epub 2011 Jan 13.

ReferenceCitation: Zou W, Chen L. Inhibitory B7-family molecules in the tumour microenvironment. Nat Rev Immunol. 2008 Jun;8(6):467-77. doi: 10.1038/nri2326. Review.

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

summary:
Standard treatment for stage III Non-Small Cells Lung Cancer (NSCLC) not eligibile for surgery is concomitant chemoradiotherapy. However median progression free survival and overall survival is still poor with only 15% of patients alive at 5 years. The addition of maintenance therapy with durvalumab after chemoradiation showed a significant benefit in PFS and OS, with good tolerability and no concerns in terms of safety. However, about 30% of patients with stage III are not eligible to concurrent chemoradiotherapy because of large volumes of the tumor. To date, these patients are initially treated with chemotherapy with the aim of reducing tumor volumes and allowing sequential radiotherapy. Response rate ranges between 25-30% and majority of patients will not become suitable for radiotherapy.

The combination of immunotherapy plus standard chemotherapy in advanced stages doubles response rates and provides major tumor shrinkage compared to standard chemotherapy alone. For these reasons, the investigators want to exploit the synergistic effect of immunotherapy combined with chemotherapy in the induction phase, in order to render suitable for radiotherapy a larger number of patients, and in a second phase the synergistic effect with radiotherapy.

Based on these premises the investigators designed a single arm, phase 2 trial to determine the efficacy and safety of combining immunotherapy with the drug durvalumab in association with standard chemotherapy and subsequently with standard radiotherapy, followed by a treatment of maintenance with only durvalumab.

The study population includes patients with NSCLC not eligible for surgery or concurrent chemoradiation at diagnosis because of large tumor volumes.

BRIDGE trial aims to evaluate the proportion of patients who did not progress and who achieved a mean lung dose <20 Gy and/or a lung V20<35% (response) after part 1. The primary objective of the study is to increase the proportion of patients eligible for immunotherapy plus radiotherapy after induction with durvalumab and chemotherapy, in comparison with historical controls.

This study will last approximately 60 months and will include approximately 65 eligible patients in 3 international cancer centres of excellence.


title: Computed Tomography Targets for Efficient Guidance of Catheter Ablation in Ventricular Tachycardia (MAP-IN-HEART)

acronym: MAP-IN-HEART

summary: The hypothesis of MAP IN HEART is that catheter ablation for post-infarction ventricular tachycardia (VT) can be largely improved through a direct definition of primary ablation targets from pre-operative CT scan imaging. The objective of is to demonstrate that catheter ablation of post-infarction VT targeting left ventricular wall thickness channels as defined from CT scan is feasible and associated with favorable efficacy, efficiency and safety profiles. A single-arm prospective cohort study will be conducted, including 40 patients over 3 European centres. Baseline, procedural and 6-month follow-up data will be analyzed

status: Active, not recruiting

ipd_sharing: Undecided

lead_sponsor: University Hospital, Bordeaux

location_country: Germany France Switzerland

location_facility: Department of Electrophysiology, Rhön-Klinikum AG

location_facility: Department of Cardiac Pacing and Electrophysiology, CHU Bordeaux


title: Phase II, Randomized, Controlled, Clinical Trial Exploring Efficacy and Safety of ERY001 (L-asparaginase Encapsulated in Red Blood Cells) in Association With Gemcitabine or FOLFOX4 in Second-line Therapy for Patients With Progressive Metastatic Pancreatic Carcinoma

lead_sponsor: ERYtech Pharma

ReferenceCitation: Bachet JB, Blons H, Hammel P, Hariry IE, Portales F, Mineur L, Metges JP, Mulot C, Bourreau C, Cain J, Cros J, Laurent-Puig P. Circulating Tumor DNA is Prognostic and Potentially Predictive of Eryaspase Efficacy in Second-line in Patients with Advanced Pancreatic Adenocarcinoma. Clin Cancer Res. 2020 Oct 1;26(19):5208-5216. doi: 10.1158/1078-0432.CCR-20-0950. Epub 2020 Jun 30.

ReferenceCitation: Hammel P, Fabienne P, Mineur L, Metges JP, Andre T, De La Fouchardiere C, Louvet C, El Hajbi F, Faroux R, Guimbaud R, Tougeron D, Bouche O, Lecomte T, Rebischung C, Tournigand C, Cros J, Kay R, Hamm A, Gupta A, Bachet JB, El Hariry I. Erythrocyte-encapsulated asparaginase (eryaspase) combined with chemotherapy in second-line treatment of advanced pancreatic cancer: An open-label, randomized Phase IIb trial. Eur J Cancer. 2020 Jan;124:91-101. doi: 10.1016/j.ejca.2019.10.020. Epub 2019 Nov 21. Erratum in: Eur J Cancer. 2020 May;130:275-276.

location_facility: Institut Regional du Cancer-Montpellier Val d'Aurelle

location_facility: Centre Hospitalier Departemental Vendee - Les Oudairies

summary:
A new approach that aims to destroy pancreatic tumor cells through modification of the tumor environment.

Asparagine synthetase (ASNS) is an enzyme wich synthetise asparagine. Asparagine is an essential nutriment for pancreatic cancer cells which have no or low level of ASNS.

by L-asparaginase encapsulated in erythrocytes deplete (supress) Plasma asparagine.

in selected patients having no or low ASNS, may provide a new therapeutic approach.


acronym: ANTHARTIC

title: Prevention of Early Ventilator-associated Pneumonia With Antibiotic Therapy in Patients Treated With Mild Therapeutic Hypothermia After Cardiac Arrest.

lead_sponsor: University Hospital, Limoges

ReferenceCitation: François B, Cariou A, Clere-Jehl R, Dequin PF, Renon-Carron F, Daix T, Guitton C, Deye N, Legriel S, Plantefève G, Quenot JP, Desachy A, Kamel T, Bedon-Carte S, Diehl JL, Chudeau N, Karam E, Durand-Zaleski I, Giraudeau B, Vignon P, Le Gouge A; CRICS-TRIGGERSEP Network and the ANTHARTIC Study Group. Prevention of Early Ventilator-Associated Pneumonia after Cardiac Arrest. N Engl J Med. 2019 Nov 7;381(19):1831-1842. doi: 10.1056/NEJMoa1812379.

location_facility: AP-HP - Hôpital Européen Georges Pompidou - Service de Réanimation

location_facility: CHU de Limoges - Service de réanimation polyvalente

location_facility: AP-HP - Hôpital pointcaré - Service de Réanimation

location_facility: AP-HP - Hôpital Cochin - Service de Réanimation

location_facility: AP-HP - Hôpital Lariboisière - Service de Réanimation

location_facility: CH Brive La Gaillarde - Service de Réanimation

summary:
Mild therapeutic hypothermia is currently recommended in management of cardiac arrests with shockable rhythm. In mechanically ventilated patients who were resuscitated after out-of-hospital cardiac arrests, mild therapeutic hypothermia side effects are conductive for infectious complications and especially for ventilator-associated pneumonia (VAP).

Despite high incidence of VAP and other infectious complications, it is not currently recommended to use antibiotic prophylaxis on the responsible germs. Yet VAP incidence could be decreased if an antibiotic therapy was systematically given to patient treated with mild therapeutic hypothermia after a cardiac arrest. Several retrospective studies showed less infectious complications but also decreased morbidity and mortality related to these complications when antibiotic therapy was given early to patients treated with therapeutic hypothermia after cardiac arrest.


title: Integrated Care of Co-morbidities vs Standard Care After Acute Hypercapnic Respiratory Failure in the Intensive Care Unit: a Randomized Controlled Trial

acronym: TMIRA

summary: The study will assess the potential benefit of implementing a complex bundle of interventions to treat important - often unrecognized - comorbidities in patients surviving an episode of Acute Hypercapnic Respiratory Failure (AHRF). This study will also provide a comparative analysis of the costs and health consequences of two alternative strategies to inform decision making about healthcare. All interventions are individually evidence-based and seem sound to hypothesize that implementing such interventions might improve patient's outcome and reduce the financial burder of repeated hospitalization in AHRF survivors.

lead_sponsor: Dan Adler

location_country: France Switzerland

location_facility: Centre Hospitalier Universitaire Grenoble Alpes

location_facility: Centre Hospitalier Universitaire Vaudois


title: A Prospective, Randomized, Multicentric Clinical Evaluation Comparing a Monofocal Extended Depth of Focus IOL With a Monofocal IOL

acronym: MonoeDOF

summary:
Post-market, prospective, randomized, single-masked, multi-center clinical study investigating the safety and effectiveness of the Monofocal Extended Depth of Focus Intraocular Lens (Mono-EDoF IOL) when compared to a Standard Monofocal Intraocular Lens.

Primary Objectives:

To evaluate the distance VA of the study IOLs
To evaluate the intermediate VA of the study IOLs
To explore the safety profile with regards to visual disturbances

status: Unknown status

ReferenceCitation: Black S. Successful Restoration of Visual Acuity with an Extended Range of Vision Intraocular Lens after Multifocal Laser Ablation. Case Rep Ophthalmol. 2016 Oct 11;7(3):193-197. doi: 10.1159/000450675. eCollection 2016 Sep-Dec.

ReferenceCitation: Bostanci Ceran B, Takmaz T, Can İ, Demirok G, Uysal BS. Clinical outcomes and optical performance of four differentmultifocal intraocular lenses. Turk J Med Sci. 2016 Apr 19;46(3):597-603. doi: 10.3906/sag-1403-24.

ReferenceCitation: Cillino S, Casuccio A, Di Pace F, Morreale R, Pillitteri F, Cillino G, Lodato G. One-year outcomes with new-generation multifocal intraocular lenses. Ophthalmology. 2008 Sep;115(9):1508-16. doi: 10.1016/j.ophtha.2008.04.017. Epub 2008 Jun 5.

ReferenceCitation: Cochener B; Concerto Study Group. Clinical outcomes of a new extended range of vision intraocular lens: International Multicenter Concerto Study. J Cataract Refract Surg. 2016 Sep;42(9):1268-1275. doi: 10.1016/j.jcrs.2016.06.033.

ReferenceCitation: Davison JA, Simpson MJ. History and development of the apodized diffractive intraocular lens. J Cataract Refract Surg. 2006 May;32(5):849-58.

ReferenceCitation: de Silva SR, Evans JR, Kirthi V, Ziaei M, Leyland M. Multifocal versus monofocal intraocular lenses after cataract extraction. Cochrane Database Syst Rev. 2016 Dec 12;12:CD003169. doi: 10.1002/14651858.CD003169.pub4. Review.

ReferenceCitation: Harman FE, Maling S, Kampougeris G, Langan L, Khan I, Lee N, Bloom PA. Comparing the 1CU accommodative, multifocal, and monofocal intraocular lenses: a randomized trial. Ophthalmology. 2008 Jun;115(6):993-1001.e2. Epub 2007 Nov 26.

ReferenceCitation: Hashemi H, Khabazkhoob M, Soroush S, Shariati R, Miraftab M, Yekta A. The location of incision in cataract surgery and its impact on induced astigmatism. Curr Opin Ophthalmol. 2016 Jan;27(1):58-64. doi: 10.1097/ICU.0000000000000223. Review.

ReferenceCitation: Kaymak H, Höhn F, Breyer DR, Hagen P, Klabe K, Gerl RH, Mueller M, Auffarth GU, Gerl M, Kretz FT. [Functional Results 3 Months after Implantation of an "Extended Range of Vision" Intraocular Lens]. Klin Monbl Augenheilkd. 2016 Aug;233(8):923-7. doi: 10.1055/s-0042-104064. Epub 2016 Jul 6. German.

ReferenceCitation: Lan J, Huang YS, Dai YH, Wu XM, Sun JJ, Xie LX. Visual performance with accommodating and multifocal intraocular lenses. Int J Ophthalmol. 2017 Feb 18;10(2):235-240. doi: 10.18240/ijo.2017.02.09. eCollection 2017.

ReferenceCitation: Pedrotti E, Bruni E, Bonacci E, Badalamenti R, Mastropasqua R, Marchini G. Comparative Analysis of the Clinical Outcomes With a Monofocal and an Extended Range of Vision Intraocular Lens. J Refract Surg. 2016 Jul 1;32(7):436-42. doi: 10.3928/1081597X-20160428-06.

ReferenceCitation: Prasher P, Sandhu JS. Prevalence of corneal astigmatism before cataract surgery in Indian population. Int Ophthalmol. 2017 Jun;37(3):683-689. doi: 10.1007/s10792-016-0327-z. Epub 2016 Aug 27.

ReferenceCitation: TECNIS Symfony DFU

ReferenceCitation: Ruiz-Mesa R, Abengózar-Vela A, Aramburu A, Ruiz-Santos M. Comparison of visual outcomes after bilateral implantation of extended range of vision and trifocal intraocular lenses. Eur J Ophthalmol. 2017 Jun 26;27(4):460-465. doi: 10.5301/ejo.5000935. Epub 2017 Jan 28.

ReferenceCitation: Weeber HA, Meijer ST, Piers PA. Extending the range of vision using diffractive intraocular lens technology. J Cataract Refract Surg. 2015 Dec;41(12):2746-54. doi: 10.1016/j.jcrs.2015.07.034.

ReferenceCitation: Attia MSA, Auffarth GU, Kretz FTA, Tandogan T, Rabsilber TM, Holzer MP, Khoramnia R. Clinical Evaluation of an Extended Depth of Focus Intraocular Lens With the Salzburg Reading Desk. J Refract Surg. 2017 Oct 1;33(10):664-669. doi: 10.3928/1081597X-20170621-08.

ReferenceCitation: Bellucci R. Multifocal intraocular lenses. Curr Opin Ophthalmol. 2005 Feb;16(1):33-7. Review.

lead_sponsor: Advanced Vision Science, Inc.

location_country:
France
Portugal
United Kingdom

location_facility:
University Hospital Pellegrin
Oxford Eye Hospital
Hospital de Braga

intervention_type: Procedure


acronym: ADEQUATE

title: Efficacy and Safety Outcome of Two Different Targets of Advagraf® Trough Levels Between 4 Months and 12 Months After Transplantation Among de Novo Renal Transplant Recipients.

lead_sponsor: University Hospital, Tours

ReferenceCitation: Gatault P, Kamar N, Büchler M, Colosio C, Bertrand D, Durrbach A, Albano L, Rivalan J, Le Meur Y, Essig M, Bouvier N, Legendre C, Moulin B, Heng AE, Weestel PF, Sayegh J, Charpentier B, Rostaing L, Thervet E, Lebranchu Y. Reduction of Extended-Release Tacrolimus Dose in Low-Immunological-Risk Kidney Transplant Recipients Increases Risk of Rejection and Appearance of Donor-Specific Antibodies: A Randomized Study. Am J Transplant. 2017 May;17(5):1370-1379. doi: 10.1111/ajt.14109. Epub 2017 Jan 3.

location_facility:
Hôpital Cavale Blanche
CHU de Caen
Hôpital Bicêtre
Hôpital Gabriel Montpied
Hôpital Sud
Hôpital Maison Blanche
Hôpital Archet II
CHU de Toulouse
Hôpital Civil
Hôpital Necker
Hôpital Pontchaillou
CHRU de Tours
CHU de Angers
Hôpital Bois-Guillaume
HEGP
Hôpital Dupuytren

summary: This prospective, interventional, open label, randomized, multicenter study was designed to determine the risk/benefit ratio of a 50 % reduction of Advagraf® daily dose, 4 months after transplantation. Randomized patients are to be stable with their tacrolimus daily dose required to reach targeted tacrolimus trough levels. Based on Month-3 eligibility assessments, patients will be randomized in two groups (1:1): patients with 50 % reduction of the daily dose of Advagraf® 4 months after transplantation, and patients kept on their usual dose. The benefit/risk ratio will include the assessment of renal function, histological lesions from both alloreactivity and CNI nephrotoxicity, and safety data (metabolic and infectious diseases).


title: Phase II, Multicenter, Open-label, Rct With an Adaptive Design, to Assess Efficacy of Intravenous Administration of Oxytocin in Hospitalized Patients Affected by COVID-19

summary:
Introduction There are currently no treatments with demonstrated efficacy for COVID-19 infection. Epidemiological evidence points to the existence of intrinsic protection factors which make young persons and women more resistant to the infection, whereas older patients with multiple illnesses, above all with heart disease, are at greatest risk. This trial proposes treatment initiated in the early stages of the disease, when clinical worsening is most likely, with intravenous Oxytocin (OT), an endogenous hormone currently safely used in clinical practice. The selection of this molecule is based on numerous experimental and clinical observations, which show its activity in modulating resistance to pathogens, in mitigating overall cardiovascular risk, and in acting on the production of Nitric Oxide (ON) in the lungs, which is emerging as a key therapeutic factor for the improvement of respiratory function in patients with SARS-COVID 19. Finally, OT is physiologically produced by the human body, especially in the female sex and in the age ranges that coincide with most resistant patients. In routine clinical practice, OT exhibits an excellent therapeutic index, in absence of significant adverse effects.

Primary aim To assess the effects of Oxytocin in addition to standard therapy, with respect to Standard of Care (SoC), in reducing the number of patients who enter a critical stage Secondary aim

To describe:

Mortality 28 days after randomization
Time to mechanical ventilation during the study
Duration of dependency on oxygen supply
Length of stay
Temporal trend of clinical improvement (7-category ordinal scale)
Safety analysis

status: Withdrawn

lead_sponsor: Azienda Ospedaliero-Universitaria di Parma

location_country: France Italy

location_facility: Azienda Ospedaliero Universitaria di Parma


primary_purpose: Basic Science

acronym: PERMIN

title: Exploratory Study of L.S.E.S.r. (PERMIXON® 160 mg Hard Capsule) Versus Tamsulosine LP Activity on Inflammation Biomarkers in the Treatment of Urinary Symptoms Related to BPH; a Multinational, Multicentric, Randomised, Double Blind Parallel-group Prospective Study

lead_sponsor: Pierre Fabre Medicament

location_country: France Portugal Spain Italy

summary:
Inflammation is reported as one of the most recent hypotheses to explain BPH. Recent published works pointed out that urine and serum markers could be used for detection of prostatic inflammation.

The aim of the study is to assess the activity on inflammation biomarkers (serum and urine inflammation markers) of Permixon® 160 mg hard capsule and Tamsulosine Arrow LP in the treatment of urinary symptoms related to BPH.

The potential links between serum and urinary markers of inflammation and BPH clinical symptoms at baseline and on treatment will be explored.


title: Open Label, Phase I Study to Assess and Compare the Pharmacokinetic Parameters After Single Oral Administration of MD1003 100 mg in Hepatic Impaired Patients and Healthy Subjects With Normal Hepatic Function

summary:
This is a Phase 1, multicentric, open-label,two arms to assess and compare the effect of single oral administration of MD1003 on the pharmacokinetic parameters in hepatic impaired patients and healthy subjects with normal hepatic function.

The planned enrollment is 16 subjects (8 impaired patients and 8 healthy subjects).

primary_purpose: Other

lead_sponsor: MedDay Pharmaceuticals SA

location_country: Hungary France

location_facility:
Clinical Research Units Hungary Ltd.
DRC Drug Research Center Ltd.
Eurofins Optimed


title: Obstetric Outcomes of Women Suffering From Hereditary Fibrinogen Disorders

acronym: FIBRINOGEST

summary: The aim of this observational study is to evaluate the prevalence of uncomplicated pregnancies in women suffering from congenital fibrinogen disorders (i.e, hypofibrinogenemia, dysfibrinogenemia, hypodysfibrinogenemia) as well as to describe pregnancies outcomes in such diseases.

time_perspective: Retrospective

lead_sponsor: University Hospital, Geneva

location_country: France Slovakia Switzerland

location_facility: Jessenius Faculty of Medicine and University Hospital


title: Single-blind Randomised Pragmatic Trial Comparing the Effectiveness of Two Hyaluronic Acid Viscosupplements, DUROLANE® (Single Injection) Versus HYALGAN® (Three Injections) for Symptomatic Tibiofemoral Osteoarthritis of the Knee.

summary: The purpose of this study is to assess whether a single injection hyaluronic acid (HA) product is not inferior to a 3 injection HA product at 24 weeks (6 months), in terms of effectiveness in reducing pain when walking in patients suffering from symptomatic tibiofemoral osteoarthritis of the knee.

lead_sponsor: Bioventus LLC

location_country: France Monaco

location_facility: Institut de l'Appareil Locomoteur - Nollet

location_facility: Centre Hospitalier de Belfort-Montbeliard


title: An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects With Giant Cell Rich Tumors of Bone

summary: An open-label, multi-center, phase 2 study of the efficacy of denosumab in subjects with giant cell rich tumors of bone. The population will consist of subjects with the following tumor types: aneurysmal bone cysts (ABC), giant cell granuloma (GCG) and other giant cell rich lesions (primary bone, non-malignant).

lead_sponsor: Leiden University Medical Center

location_country: Netherlands France Italy

location_facility:
Centre Léon Bérard
Istituto Ortopedico Rizzoli
Leiden University Medical Center


title: An Open-label Study of MabThera on Objective Overall Tumor Response in Treatment-naïve Patients With Non-bulky Follicular Non-Hodgkin's Lymphoma

summary: This study will evaluate the efficacy and safety of MabThera/Rituxan (rituximab) in treatment-naive patients with non-bulky follicular non-Hodgkin's lymphoma. The anticipated time on study treatment is 3 months.

lead_sponsor: Hoffmann-La Roche


title: Phase II Randomized Trial to Evaluate Two Strategies: Continuing Versus Intermittent (Drug-holiday) Trabectedin-regimen in Patients With Advanced Soft Tissue Sarcoma Experiencing Response or Stable Disease After the Sixth Cycle

acronym: T-DIS

summary:
This randomization discontinuation trial will allow for concomitant evaluation of the following:

Side effects and benefits of immediate continuation of Trabectedin after the sixth cycle
Side effects and benefits of a drug holiday

ReferenceCitation: Le Cesne A, Blay JY, Domont J, Tresch-Bruneel E, Chevreau C, Bertucci F, Delcambre C, Saada-Bouzid E, Piperno-Neumann S, Bay JO, Mir O, Ray-Coquard I, Ryckewaert T, Valentin T, Isambert N, Italiano A, Clisant S, Penel N. Interruption versus continuation of trabectedin in patients with soft-tissue sarcoma (T-DIS): a randomised phase 2 trial. Lancet Oncol. 2015 Mar;16(3):312-9. doi: 10.1016/S1470-2045(15)70031-8. Epub 2015 Feb 11.

lead_sponsor: Centre Oscar Lambret

location_facility:
Institut Bergonié
Centre Georges François Leclerc
CHU Timone Adultes
Centre Jean Perrin
Centre Antoine Lacassagne
Léon Bérard Center
Centre René Huguenin
Centre Léon Bérard
Centre Oscar Lambret
Institut Gustave Roussy
Paoli Calmette Institute
Centre Henri Becquerel
Institut Claudius Regaud
Institut Curie
Centre François Baclesse
Saint-Jacques Hospital


title: An Open-label Study of Avastin in Combination With Chemotherapy Regimens as Second-line Treatment in Patients With Metastatic Colon or Rectal Cancer

summary: This study will assess the efficacy and safety of intravenous Avastin in combination with chemotherapy regimens as second-line treatment of metastatic cancer of the colon or rectum. The anticipated time of study treatment is until disease progression.


title: PULsecath mechanicaL Support Evaluation (PULSE) - Trial

acronym: PULSE

summary: The objective of this study is to determine ventricular loading conditions during and after PulseCath® iVAC2L support, and assess its impact on specific load dependent humoral factors and cardiac enzymes. These specific patterns are so far unknown and will be evaluated invasively.

ReferenceCitation: Bastos MB, McConkey H, Malkin O, den Uil C, Daemen J, Patterson T, Wolff Q, Kardys I, Schreuder J, Lenzen M, Zijlstra F, Redwood S, Van Mieghem NM. Effect of Next Generation Pulsatile Mechanical Circulatory Support on Cardiac Mechanics: The PULSE Trial. Cardiovasc Revasc Med. 2022 Sep;42:133-142. doi: 10.1016/j.carrev.2022.03.013. Epub 2022 Mar 14.

ReferenceCitation: Dedic A, Bastos MB, Van Mieghem NM. Pressure-Volume Loop Analysis in Percutaneous Coronary Intervention-Induced Shock. JACC Case Rep. 2020 Sep 23;2(12):1882-1883. doi: 10.1016/j.jaccas.2020.07.026. eCollection 2020 Oct.

lead_sponsor: Erasmus Medical Center

location_country:
Netherlands
France
United Kingdom

location_facility: Kings College London, St. Thomas' Hospital


title: Oligogenic Determinism of Colorectal Cancer

acronym: DOCC

summary:
The majority of the clinical situations suggestive of an increased genetic risk for colorectal cancer (CRC) are not explained by a simple monogenic model. Our working hypothesis is that a fraction of clinical conditions suggestive of an increased genetic risk for CRC (familial aggregation, early age of tumour onset, development of multiple primary CRC) is due to the combination of a limited number of genetic variations, each conferring a moderate risk for CRC, but whose combination results into high risk.

This study, which will be both retrospective and prospective, is an association study that will compare frequencies of selected genetic variations, alone or in combination, between patients (cases) whose clinical presentation is suggestive of an increased genetic risk but who do not present a known Mendelian form of CRC, and controls, in order to assess associations of these variations with non-Mendelian genetic forms of CRC. The inclusion criteria will be: CRC in two first degree relatives, one being diagnosed before 61 years of age; or CRC diagnosed before 51 years of age or advanced colorectal adenoma before 41 years of age; or multiple primary CRCs in the same individual, the first being diagnosed before 61 years of age The exclusion criteria will be: Lynch syndrome, adenomatous polyposis and hamartomatous polyposis. The genetic variations which will be analyzed will include (i) SNPs detected by GWAS and associated to CRC. (ii) Risk factors corresponding to functional polymorphisms within candidate genes. (iii) Imbalance of the TGFbR1 allelic expression. Sample sizes were calculated to obtain 80% power for an odds ratio of 2.5 since the aim of this study is to determine genetic variations conferring a moderate risk. In order to cover all these possibilities and to have reasonable even for the genetic variations with low frequency below 0.03 or high frequency above 0.90, the target sample size was set at 700 cases and 350 controls. The recruitment of patients will be performed at the national level by the cancer genetics departments ensuring a correct evaluation of the personal and familial history and the French molecular diagnosis laboratories network ensuring in routine the analysis of the main genes involved in CRC. The control population will be composed of healthy subjects of Caucasian origin between 45 and 60 years of age, without personal or familial history among their first-degree relatives of colorectal tumours.

Demonstration that the combination of a limited number of genetic variations, each conferring a moderate risk for CRC, results into high risk would allow to base, in selected families, the evaluation of risk in relatives and indication of colonoscopy on the analysis of gene variants the combination of which would confer a high risk. This study will confirm or invalidate the contribution of aTGFbR1 allelic expression imbalance in the determinism of early-onset CRC and familial aggregation of CRC. The demonstration of the involvement in CRC genetic variations with strong effect of specific combinations should be of interest for our general understanding of the molecular basis of CRC.

lead_sponsor: University Hospital, Rouen

location_facility:
CLCC Val d'Aurelle
CHU de Saint-Etienne
CHU de Grenoble
Hôpital Européen Georges Pompidou
Centre Eugène Marquis
CHU de Dijon
CHU de Toulouse
Institut Gustave Roussy
CH de Niort
CHRU de Lille
Institut Claudius Regaud
CHU de Montpellier
Institut Curie
Centre François Baclesse
UHRouen
CHU de Rennes

intervention_type: Genetic


title: A First-in Human Phase I, Non-randomised, Open-label, Multi-center Dose Escalation Trial of BI 836880 Administered by Repeated Intravenous Infusions in Patients With Solid Tumors.

summary: This is a Phase I, non-randomized, uncontrolled, open-label, dose escalating study of BI 836880 administered intravenously. The eligible patient population will be patients with advanced solid tumours. At any time during the trial, it will not be permitted to escalate to a dose which does not fulfil the escalation with overdose control (EWOC) criterion

ReferenceCitation: Le Tourneau C, Becker H, Claus R, Elez E, Ricci F, Fritsch R, Silber Y, Hennequin A, Tabernero J, Jayadeva G, Luedtke D, He M, Isambert N. Two phase I studies of BI 836880, a vascular endothelial growth factor/angiopoietin-2 inhibitor, administered once every 3 weeks or once weekly in patients with advanced solid tumors. ESMO Open. 2022 Oct;7(5):100576. doi: 10.1016/j.esmoop.2022.100576. Epub 2022 Sep 13.

lead_sponsor: Boehringer Ingelheim

location_country: Germany France

location_facility:
INS Curie
Universitätsklinikum Freiburg
Universitätsklinikum Augsburg


title: Treatment of AML in Adults 50 to 70 Years, Study of Two Anthracyclines and the Interest of Maintenance Treatment With Interleukin 26- ALFA 9801

acronym: ALFA 9801

summary: Randomized comparison of standard induction treatment with daunorubicin for 3 days and Idarubicin for 3 or 4 days in adult AML patients between 50 and 70 years. Study of maintenance treatment with IL2

ReferenceCitation: Sarkozy C, Gardin C, Gachard N, Merabet F, Turlure P, Malfuson JV, Pautas C, Micol JB, Thomas X, Quesnel B, Celli-Lebras K, Preudhomme C, Terré C, Fenaux P, Chevret S, Castaigne S, Dombret H. Outcome of older patients with acute myeloid leukemia in first relapse. Am J Hematol. 2013 Sep;88(9):758-64. doi: 10.1002/ajh.23498. Epub 2013 Aug 7.

ReferenceCitation: Gardin C, Chevret S, Pautas C, Turlure P, Raffoux E, Thomas X, Quesnel B, de Revel T, de Botton S, Gachard N, Renneville A, Boissel N, Preudhomme C, Terré C, Fenaux P, Bordessoule D, Celli-Lebras K, Castaigne S, Dombret H. Superior long-term outcome with idarubicin compared with high-dose daunorubicin in patients with acute myeloid leukemia age 50 years and older. J Clin Oncol. 2013 Jan 20;31(3):321-7. doi: 10.1200/JCO.2011.40.3642. Epub 2012 Dec 17.

ReferenceCitation: Itzykson R, Gardin C, Pautas C, Thomas X, Turlure P, Raffoux E, Terré C, Fenaux P, Castaigne S, Dombret H, Boissel N; Acute Leukemia French Association (ALFA). Impact of post-remission therapy in patients aged 65-70 years with de novo acute myeloid leukemia: a comparison of two concomitant randomized ALFA trials with overlapping age inclusion criteria. Haematologica. 2011 Jun;96(6):837-44. doi: 10.3324/haematol.2010.036921. Epub 2011 Apr 1.

ReferenceCitation: Boissel N, Nibourel O, Renneville A, Gardin C, Reman O, Contentin N, Bordessoule D, Pautas C, de Revel T, Quesnel B, Huchette P, Philippe N, Geffroy S, Terre C, Thomas X, Castaigne S, Dombret H, Preudhomme C. Prognostic impact of isocitrate dehydrogenase enzyme isoforms 1 and 2 mutations in acute myeloid leukemia: a study by the Acute Leukemia French Association group. J Clin Oncol. 2010 Aug 10;28(23):3717-23. doi: 10.1200/JCO.2010.28.2285. Epub 2010 Jul 12.

lead_sponsor: Acute Leukemia French Association

location_facility:
St Antoine Hospital
Hopital Edouard Herriot
IGR
Hopital Saint-Louis
CHU
CNLCC
CH
Hopital Pitie-Salpetriere
Hopital Percy


title: A Randomized, Double-blind, Placebo-controlled, First-in-human, 3 Part Study of Orally Administered AL-335 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Dosing and Food-effect in Healthy Volunteers, and Multiple Ascending Dosing in Subjects With Chronic Hepatitis C Genotype 1 Infection

summary: This randomized, double-blind, placebo-controlled, 3-part study will assess the safety, tolerability, and pharmacokinetics of orally administered AL-335 in healthy volunteers (HV) and subjects with CHC infection.

ReferenceCitation: McClure MW, Berliba E, Tsertsvadze T, Streinu-Cercel A, Vijgen L, Astruc B, Patat A, Westland C, Chanda S, Zhang Q, Kakuda TN, Vuong J, Khorlin N, Beigelman L, Blatt LM, Fry J. Safety, tolerability, and pharmacokinetics of AL-335 in healthy volunteers and hepatitis C virus-infected subjects. PLoS One. 2018 Oct 16;13(10):e0204974. doi: 10.1371/journal.pone.0204974. eCollection 2018.

lead_sponsor: Alios Biopharma Inc.

location_country:
Georgia
France
Moldova, Republic of

location_facility: Arensia, Research Institute of Clinical Medicine


title: A Randomised, Assessor-blinded, Multi-centre Trial Comparing the Efficacy, Safety and Tolerability of the PICOPREP Tailored Dosing Schedule to the PICOPREP Day-before Dosing Schedule for Colon Cleansing in Preparation for Colonoscopy

acronym: OPTIMA

summary: This was a phase 3, randomised, assessor-blinded, multi-centre trial comparing the efficacy, safety and tolerability of a PICOPREP tailored dosing schedule to the PICOPREP day-before dosing schedule for colon cleansing in preparation for colonoscopy.

ReferenceCitation: Kiesslich R, Schubert S, Mross M, Klugmann T, Klemt-Kropp M, Behnken I, Bonnaud G, Keulen E, Groenen M, Blaker M, Ponchon T, Landry W, Stoltenberg M. Efficacy and safety of PICOPREP tailored dosing compared with PICOPREP day-before dosing for colon cleansing: a multi-centric randomised study. Endosc Int Open. 2017 Apr;5(4):E282-E290. doi: 10.1055/s-0043-102433.

lead_sponsor: Ferring Pharmaceuticals

location_country: Germany France Netherlands

location_facility: Medisch Centrum Alkmaar (there may be other sites in this country)

location_facility: Ed Herriot Hopital (there may be other sites in this country)

location_facility: Gastroenterologie am Bayerischen Platz (there may be other sites in this country)


title: Assessment of Hybrid Use of an Artificial Pancreas in a Home Setting for Two Months in Patients With Type 1 Diabetes

acronym: AP Hybrid

summary: The primary purpose of this study is the evaluate an Artificial Pancreas during 2 months in home setting in Type 1 Diabetic patients

ReferenceCitation: Renard E, Farret A, Kropff J, Bruttomesso D, Messori M, Place J, Visentin R, Calore R, Toffanin C, Di Palma F, Lanzola G, Magni P, Boscari F, Galasso S, Avogaro A, Keith-Hynes P, Kovatchev B, Del Favero S, Cobelli C, Magni L, DeVries JH; AP@home Consortium. Day-and-Night Closed-Loop Glucose Control in Patients With Type 1 Diabetes Under Free-Living Conditions: Results of a Single-Arm 1-Month Experience Compared With a Previously Reported Feasibility Study of Evening and Night at Home. Diabetes Care. 2016 Jul;39(7):1151-60. doi: 10.2337/dc16-0008. Epub 2016 May 5.

ReferenceCitation: Kropff J, Del Favero S, Place J, Toffanin C, Visentin R, Monaro M, Messori M, Di Palma F, Lanzola G, Farret A, Boscari F, Galasso S, Magni P, Avogaro A, Keith-Hynes P, Kovatchev BP, Bruttomesso D, Cobelli C, DeVries JH, Renard E, Magni L; AP@home consortium. 2 month evening and night closed-loop glucose control in patients with type 1 diabetes under free-living conditions: a randomised crossover trial. Lancet Diabetes Endocrinol. 2015 Dec;3(12):939-47. doi: 10.1016/S2213-8587(15)00335-6. Epub 2015 Sep 30.

lead_sponsor: University Hospital, Montpellier

location_facility:
CHU Montpellier
University of Padova
University of Amsterdam


title: A Randomized, Open Label Study Comparing the Effect of CellCept With Therapeutic Drug Monitoring, Tacrolimus and a Corticosteroid-sparing Regimen Versus Fixed Dose CellCept, Tacrolimus and Corticosteroids Maintained up to 6 Months, on Acute Rejection and Safety in Liver Transplant Patients.

summary: This 2 arm study will compare the efficacy and safety of two CellCept-containing treatment regimens in de novo liver transplant patients. Patients will be randomized into one of two groups, to receive either CellCept (at a starting dose of 3g/day po, adjusted according to exposure) standard dose tacrolimus and corticosteroids (10-15 mg/kg i.v. on day 0), or fixed dose CellCept 2g/day po, standard dose tacrolimus and corticosteroids (10-15mg/kg i.v. on day 0, then reducing from 20mg to 5mg over 6 months, and discontinuing after 6 months). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


title: A Phase I, Dose Escalation Study to Evaluate Safety and Efficacy of RP6530, a Dual PI3K Delta/Gamma Inhibitor, in Patients With Relapsed or Refractory Hematologic Malignancies

summary: The objective of this study is to evaluate the safety and efficacy of RP6530, a dual PI3K delta/gamma inhibitor in patients with hematologic malignancies.

lead_sponsor: Rhizen Pharmaceuticals SA

location_facility:
Rhizen Trial Site 2
Rhizen Trial Site
Rhizen Trial Site 1


title: Phase III, Multicentre, Open Study to Assess the Efficacy and Safety of Lanreotide Autogel (60, 90 or 120 mg) in Acromegalic Patients Previously Treated or Not by Somatostatin Analogues.

summary: To evaluate the long-term efficacy and safety of repeated injections of lanreotide Autogel given in doses titrated to effect in acromegalic patients previously treated or not with somatostatin analogues.

ReferenceCitation: Chanson P, Borson-Chazot F, Kuhn JM, Blumberg J, Maisonobe P, Delemer B; Lanreotide Acromegaly Study Group. Control of IGF-I levels with titrated dosing of lanreotide Autogel over 48 weeks in patients with acromegaly. Clin Endocrinol (Oxf). 2008 Aug;69(2):299-305. doi: 10.1111/j.1365-2265.2008.03208.x. Epub 2008 Jan 31.

lead_sponsor: Ipsen

location_facility:
Hôpital Neurologique
Hôpital de l'Archet 1
Hôpital du Haut-Levêque
Hôpital Sud
Hôpital Bellevue
Hôpital de Rangueil
Hôpital Lapeyronie
Hôpital Maison Blanche
Hôpital de Bois Guillaume
Chu de Bicêtre
Centre Hospitalier Vaudois
Hôpital de Hautepierre
Chu d'Angers
Hôpital du Bocage
Hôpital du Cluzeau
Chu de la Cote de Nacre