Clinical trial • Phase IV • Haematology

zanubrutinib for Waldenström macroglobulinemia

Phase IV trial of zanubrutinib for Waldenström macroglobulinemia. open-label, none/not specified-controlled. 102 participants.

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Waldenström macroglobulinemia
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
14-03-2024
First CTIS Authorization Date
27-06-2024

Trial design

open-label, none/not specified-controlled Phase IV trial across 40 sites in France.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
102

Eligibility

Recruits 102 Vulnerable population not selected; no specific consent or assent arrangements provided..

Vulnerable Population
Vulnerable population not selected; no specific consent or assent arrangements provided.

Recruitment

Planned Sample Size
102
Recruitment Window Months
78

Geography

Total Number Of Sites
40
Total Number Of Participants
102

France

Earliest CTIS Part Ii Submission Date
18-06-2024
Latest Decision Or Authorization Date
04-03-2026
Processing Time Days
624
Number Of Sites
40
Number Of Participants
102

Sites

Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Onco-hématologie
Contact Person Name
Elise Tousaint
Site Name
L'Hopital Prive Du Confluent
Department Name
Hématologie
Contact Person Name
Katell LE DU
Contact Person Email
kledu@vivalto-sante.com
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Hématologie et thérapie cellulaire
Contact Person Name
Nataliya Dmytruk
Site Name
Institut Gustave Roussy
Department Name
Service d'Hématologie
Contact Person Name
David Ghez
Contact Person Email
david.ghez@gustaveroussy.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service d'Hématologie
Contact Person Name
Damien Roos-Weil
Contact Person Email
damien.roosweil@aphp.fr
Site Name
Centre Hospitalier De Versailles
Department Name
Service d'hématologie-oncologie
Contact Person Name
Fatiha Merabet
Contact Person Email
fmerabet@ght78sud.fr
Site Name
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace
Department Name
Service d'Hématologie
Contact Person Name
Bernard Drenou
Contact Person Email
drenoub@ghrmsa.fr
Site Name
Centre Leon Berard
Department Name
Oncologie Médicale
Contact Person Name
Mohammed Bendouda
Site Name
Centre Hospitalier Le Mans
Department Name
Centre de Cancérologie de la Sarthe
Contact Person Name
Kamel Laribi
Contact Person Email
klaribi@ch-lemans.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Service d'Hématologie
Contact Person Name
Anne Lok
Contact Person Email
anne.lok@chu-nantes.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service d'Hématologie
Contact Person Name
Raphaëlle Aubrais
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Service d'Hématologie
Contact Person Name
Loic Ysebaert
Contact Person Email
ysebaert.loic@iuct-oncopole.fr
Site Name
CHU Henri Mondor
Department Name
Unité Hémopathies Lymphoïdes
Contact Person Name
Jehan Dupuis
Contact Person Email
jehan.dupuis@aphp.fr
Site Name
Hospices Civils De Lyon
Department Name
Hématologie Clinique - Pavillon 1 F Marcel Berard - 3ème et.
Contact Person Name
Emmanuelle Ferrant
Site Name
Centre Hospitalier Victor Dupouy Argenteuil
Department Name
Service d'Hématologie
Contact Person Name
Mariem Romdhani
Site Name
Centre Hospitalier Bretagne Atlantique
Department Name
Hématologie et thérapie cellulaire
Contact Person Name
Guillaume Aussedat
Site Name
Centre Hospitalier De Perpignan
Department Name
Service d'Hématologie clinique
Contact Person Name
Sara Burcheri
Contact Person Email
sara.burcheri@ch-perpignan.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Service d'Hématologie clinique
Contact Person Name
Charles Herbaux
Contact Person Email
c-herbaux@chu-montpellier.fr
Site Name
Centre Hospital Region Metz Thionville
Department Name
Hématologie
Contact Person Name
Philippe Carassou
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Service d'Hématologie clinique
Contact Person Name
Ghandi-Laurent Damaj
Contact Person Email
damaj-gl@chu-caen.fr
Site Name
Centre Hospitalier Universitaire D Orleans
Department Name
Service d'Hématologie
Contact Person Name
Marlène Ochmann
Contact Person Email
marlene.ochmann@chu-orleans.fr
Site Name
Centre Hospitalier Departemental Vendee
Department Name
Département Onco-Hématologie
Contact Person Name
Jessie Bourcier
Contact Person Email
jessie.bourcier@ght85.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Hématologie clinique
Contact Person Name
Lydia Montes
Contact Person Email
montes.lydia@chu-amiens.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
service Maladies du Sang
Contact Person Name
Morgane Nudel
Contact Person Email
morgane.nudel@chu-lille.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hématologie
Contact Person Name
Lise Willems
Contact Person Email
lise.willems@aphp.fr
Site Name
Besancon University Hospital Center
Department Name
Service d'Hématologie
Contact Person Name
Adrien Caillet
Contact Person Email
acaillet@chu-besancon.fr
Site Name
Institut Paoli Calmettes
Department Name
Service d'Hématologie
Contact Person Name
Anne Calleja
Contact Person Email
callejaa@ipc.unicancer.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Hématologie et thérapie cellulaire
Contact Person Name
Caroline Dartigeas
Contact Person Email
c.dartigeas@chu-tours.fr
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Service d'Hématologie
Contact Person Name
Lucile Bussot
Contact Person Email
lbussot@chu-grenoble.fr
Site Name
Groupement Des Hopitaux De L'Institut Catholique De Lille
Department Name
Onco-Hématologie
Contact Person Name
Bénédicte Hivert
Contact Person Email
hivert.benedicte@ghicl.net
Site Name
Institut Bergonie
Department Name
Service d'Hématologie
Contact Person Name
Fontanet Bijou
Contact Person Email
f.bijou@bordeaux.unicancer.fr
Site Name
Centre Henri Becquerel
Department Name
Service d'Hématologie
Contact Person Name
Stéphane Lepretre
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Service d'Hématologie clinique
Contact Person Name
Amandine Durand
Contact Person Email
amandine.durand@chu-dijon.fr
Site Name
Centre Hospitalier Universitaire Reims
Department Name
Service d'Hématologie
Contact Person Name
Eric Durot
Contact Person Email
edurot@chu-reims.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Service d'Hématologie
Contact Person Name
Cécile Tomowiak
Site Name
CHRU De Nancy
Department Name
Service d'Hématologie
Contact Person Name
Pierre Feugier
Contact Person Email
p.feugier@chru-nancy.fr
Site Name
Centre Hospitalier Annecy Genevois
Department Name
Service d'Hématologie
Contact Person Name
Stéphanie Tardy
Contact Person Email
stardy@ch-annecygenevois.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
zanubrutinib
Active Substance
zanubrutinib
Modality
Small molecule
Investigational Product Name
BGB-11417
Active Substance
BGB-11417
Modality
Small molecule
Combination Treatment
Yes

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