Clinical trial • Phase IV • Haematology

Venetoclax for Chronic lymphocytic leukaemia (CLL) | IGHV-unmutated CLL

Phase IV trial of Venetoclax for Chronic lymphocytic leukaemia (CLL) | IGHV-unmutated CLL. 45 participants.

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Chronic lymphocytic leukaemia (CLL) | IGHV-unmutated CLL
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
22-07-2024
First CTIS Authorization Date
01-08-2024

Trial design

Phase IV trial across 20 sites in France.

Target Sample Size
45

Eligibility

Recruits 45 Vulnerable population not selected; no specific consent/assent handling described..

Vulnerable Population
Vulnerable population not selected; no specific consent/assent handling described.

Recruitment

Planned Sample Size
45
Recruitment Window Months
130

Geography

Total Number Of Sites
20
Total Number Of Participants
45

France

Earliest CTIS Part Ii Submission Date
30-07-2024
Latest Decision Or Authorization Date
01-08-2024
Processing Time Days
2
Number Of Sites
20
Number Of Participants
45

Sites

Site Name
Centre Hospitalier Universitaire De Saint Etienne
Department Name
hematologie
Contact Person Name
Emilie Chalayer
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
hematologie
Contact Person Name
Pierre Morel
Contact Person Email
morel.pierre@chu-amiens.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
maladie du sang
Contact Person Name
Aline Clavert
Contact Person Email
aline.clavert@chu-angers.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
hematologie
Contact Person Name
Lysiane Molina
Contact Person Email
lmolina@chu-grenoble.fr
Site Name
Institut Paoli Calmettes
Department Name
hematologie
Contact Person Name
thérèse Aurran
Contact Person Email
auuant@ipc.unicancer.fr
Site Name
Hospices Civils De Lyon
Department Name
hematologie
Contact Person Name
Emmanuelle Ferrant
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
hematologie
Contact Person Name
Béatrice Mahé
Contact Person Email
beatrice.mahe@chu-nantes.fr
Site Name
CHRU Tours Hopital Bretonneau
Department Name
hematologie
Contact Person Name
Caroline Dartigeas
Contact Person Email
c.dartigeas@chu-tours.fr
Site Name
Centre Hospitalier Departemental Vendee
Department Name
hematologie
Contact Person Name
Bruno Villemangne
Contact Person Email
bruno.villemagne@chd-vendee.fr
Site Name
Centre Hospitalier Le Mans
Department Name
hematologie
Contact Person Name
Kamel Laribi
Contact Person Email
klaribi@ch-lemans.fr
Site Name
CHU Reunion site sur
Department Name
hematologie
Contact Person Name
Hugo Legendre
Contact Person Email
hugo.legendre@chu-reunion.fr
Site Name
Centre Hospitalier Universitaire D Orleans
Department Name
hematologie
Contact Person Name
Omar Benbrahim
Contact Person Email
omar.benbrahim@chr-orleans.fr
Site Name
Hopital Prive Sevigne
Department Name
hematologie
Contact Person Name
Xavier Cahu
Contact Person Email
dr.xavier.cahu@gmail.com
Site Name
Centre Hospitalier De Beziers
Department Name
hematologie
Contact Person Name
Alain Saad
Contact Person Email
alain.saad@ch-beziers.fr
Site Name
Centre Leon Berard
Department Name
hematologie
Contact Person Name
Anne-sophie Michallet
Site Name
Centre Hospitalier De Versailles
Department Name
hematologie
Contact Person Name
Fatiha Merabet
Contact Person Email
fmerabet@ch-versailles.fr
Site Name
Centre Henri Becquerel
Department Name
hematologie
Contact Person Name
Stéphane Lepretre
Site Name
Centre Hospitalier De Perpignan
Department Name
hematologie
Contact Person Name
Laurence Sanhes
Site Name
Hôpital Avicenne
Department Name
hematologie
Contact Person Name
Vincent Levy
Contact Person Email
vincent.levy@aphp.fr
Site Name
CHU Henri Mondor
Department Name
hematologie
Contact Person Name
Jehan dupuis
Contact Person Email
jehan.dupuis@aphp.fr

Sponsor

Primary sponsor

Full Name
French Innovative Leukemia Organization
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
Venetoclax
Active Substance
Venetoclax
Modality
Small molecule

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