Clinical trial • Phase IV • Oncology|Haematology|Immunology

Clinical trial in Acute lymphoblastic leukemia (ALL)

Phase IV trial for Acute lymphoblastic leukemia (ALL). 1506 participants.

Overview

Trial Therapeutic Area
Oncology|Haematology|Immunology
Trial Disease
Acute lymphoblastic leukemia (ALL)
Trial Stage
Phase IV

Key dates

Initial CTIS Submission Date
11-10-2024
First CTIS Authorization Date
14-11-2024

Trial design

Phase IV trial across 57 sites in France, Belgium.

Target Sample Size
1506

Recruitment

Planned Sample Size
1506
Recruitment Window Months
144

Geography

Total Number Of Sites
57
Total Number Of Participants
1506

France

Earliest CTIS Part Ii Submission Date
24-10-2024
Latest Decision Or Authorization Date
14-11-2024
Processing Time Days
21
Number Of Sites
50
Number Of Participants
1306

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Unité fonctionnelle d’Hématologie
Principal Investigator Name
Justine Decroocq
Principal Investigator Email
justine.decroocq@aphp.fr
Contact Person Name
Justine Decroocq
Contact Person Email
justine.decroocq@aphp.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Service d'Hématologie-Oncologie
Principal Investigator Name
Sarah Bonnet,
Principal Investigator Email
Sarah.bonnet@chu-montpellier.fr
Contact Person Name
Sarah Bonnet,
Site Name
Institut Curie
Department Name
Hématologie - Médecine E
Principal Investigator Name
Jacques VARGAFTIG
Principal Investigator Email
jacques.vargaftig@curie.fr
Contact Person Name
Jacques VARGAFTIG
Contact Person Email
jacques.vargaftig@curie.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service d’Hématologie clinique et thérapie cellulaire
Principal Investigator Name
Eolia Brissot
Principal Investigator Email
eolia.brissot@aphp.fr
Contact Person Name
Eolia Brissot
Contact Person Email
eolia.brissot@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service d'Hématologie Adulte
Principal Investigator Name
NICOLAS BOISSEL
Principal Investigator Email
nicolas.boissel@aphp.fr
Contact Person Name
NICOLAS BOISSEL
Contact Person Email
nicolas.boissel@aphp.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Service d’Hématologie
Principal Investigator Name
Françoise Huguet,
Principal Investigator Email
huguet.francoise@iuct-oncopole.fr
Contact Person Name
Françoise Huguet,
Site Name
Centre Henri Becquerel
Department Name
Service d'Hématologie Adulte
Principal Investigator Name
Emilie Lemasle Emilie
Principal Investigator Email
emilie.lemasle@chb.unicancer.fr
Contact Person Name
Emilie Lemasle Emilie
Site Name
CHRU De Nancy
Department Name
Service d’Hématologie-médecine interne
Principal Investigator Name
Caroline Bonmati,
Principal Investigator Email
c.bonmati@chru-nancy.fr
Contact Person Name
Caroline Bonmati,
Contact Person Email
c.bonmati@chru-nancy.fr
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Service d’Hématologie
Principal Investigator Name
Jean-Noël Bastie
Principal Investigator Email
jean-noel.bastie@chu-dijon.fr
Contact Person Name
Jean-Noël Bastie
Contact Person Email
jean-noel.bastie@chu-dijon.fr
Site Name
Institut Gustave Roussy
Department Name
Service d'Hématologie
Principal Investigator Name
Florence Pasquier
Principal Investigator Email
florence.pasquier@gustaveroussy.fr
Contact Person Name
Florence Pasquier
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service d’Hématologie
Principal Investigator Name
Madalina Uzunov
Principal Investigator Email
madalina.uzunov@aphp.fr
Contact Person Name
Madalina Uzunov
Contact Person Email
madalina.uzunov@aphp.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Service d’Hématologie Clinique du Pr. Marolleau
Principal Investigator Name
Marlène Joris
Principal Investigator Email
Joris.Magalie@chu-amiens.fr
Contact Person Name
Marlène Joris
Contact Person Email
Joris.Magalie@chu-amiens.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Service d’Hématologie et thérapie cellulaire
Principal Investigator Name
Emmanuel Gyan,
Principal Investigator Email
emmanuel.gyan@univ-tours.fr
Contact Person Name
Emmanuel Gyan,
Contact Person Email
emmanuel.gyan@univ-tours.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Service d’Hématologie
Principal Investigator Name
Sylvain Chantepie,
Principal Investigator Email
chantepie-s@chu-caen.fr
Contact Person Name
Sylvain Chantepie,
Contact Person Email
chantepie-s@chu-caen.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Service d’Hématologie Clinique du Pr. Marolleau
Principal Investigator Name
Martine Escoffre Barbe,
Principal Investigator Email
martine.escoffre-barbe@chu-rennes.fr
Contact Person Name
Martine Escoffre Barbe,
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service d’Hématologie Clinique Adultes
Principal Investigator Name
Felipe Suarez,
Principal Investigator Email
felipe.suarez@aphp.fr
Contact Person Name
Felipe Suarez,
Contact Person Email
felipe.suarez@aphp.fr
Site Name
Centre Hospitalier De Versailles
Department Name
Service d’Hémato-Oncologie
Principal Investigator Name
Philippe Rousselot,
Principal Investigator Email
phrousselot@ch-versailles.fr
Contact Person Name
Philippe Rousselot,
Contact Person Email
phrousselot@ch-versailles.fr
Site Name
Centre Hospitalier De Perpignan
Department Name
Service d’Hématologie
Principal Investigator Name
Laurence Sanhes,
Principal Investigator Email
Laurence.sanhes@ch-perpignan.fr
Contact Person Name
Laurence Sanhes,
Site Name
Centre Hospitalier D Avignon
Department Name
Service d’Onco-Hématologie
Principal Investigator Name
Safia Chebrek,
Principal Investigator Email
chebrek.safia@ch-avignon.fr
Contact Person Name
Safia Chebrek,
Contact Person Email
chebrek.safia@ch-avignon.fr
Site Name
Hospices Civils De Lyon
Department Name
Service d’Hématologie
Principal Investigator Name
Marie Balsat,
Principal Investigator Email
marie_balsat@yahoo.fr
Contact Person Name
Marie Balsat,
Contact Person Email
marie_balsat@yahoo.fr
Site Name
Centre Hospitalier De La Cote Basque
Department Name
Service d’Hématologie et maladies du sang
Principal Investigator Name
Jean-Baptiste Robin
Principal Investigator Email
jbrobin@ch-cotebasque.fr
Contact Person Name
Jean-Baptiste Robin
Contact Person Email
jbrobin@ch-cotebasque.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service d’Hématologie
Principal Investigator Name
Sébastien Maury,
Principal Investigator Email
sebastien.maury@aphp.fr
Contact Person Name
Sébastien Maury,
Contact Person Email
sebastien.maury@aphp.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Service d’Hématologie
Principal Investigator Name
Laure FARNAULT
Principal Investigator Email
laure-farnault@yahou.fr
Contact Person Name
Laure FARNAULT
Contact Person Email
laure-farnault@yahou.fr
Site Name
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace
Department Name
Service d’Hématologie
Principal Investigator Name
Mario Ojeda Uribe
Principal Investigator Email
OJEDA-URIBEM@ch-mulhouse.fr
Contact Person Name
Mario Ojeda Uribe
Contact Person Email
OJEDA-URIBEM@ch-mulhouse.fr
Site Name
Centre Hospitalier De Roubaix
Department Name
Service d’Hématologie
Principal Investigator Name
Isabelle Plantier
Principal Investigator Email
isabelle.plantier@ch-roubaix.fr
Contact Person Name
Isabelle Plantier
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service d'Hématologie
Principal Investigator Name
Thorsten Braun,
Principal Investigator Email
thorsten.braun@aphp.fr
Contact Person Name
Thorsten Braun,
Contact Person Email
thorsten.braun@aphp.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Service d'Oncologie Hématologique et Thérapie Cellulaire
Principal Investigator Name
Pilar Gallego
Contact Person Name
Pilar Gallego
Site Name
Centre Hospitalier Sud Francilien
Department Name
Service d’Hématologie
Principal Investigator Name
Celia Salanoubat
Principal Investigator Email
i.guibaud@chr-metz-thionville.fr
Contact Person Name
Celia Salanoubat
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Service des Maladies du Sang
Principal Investigator Name
Céline Berthon,
Principal Investigator Email
celine.berthon@chru-lille.fr
Contact Person Name
Céline Berthon,
Contact Person Email
celine.berthon@chru-lille.fr
Site Name
Chorale Du Centre Hospitalier De Lens
Department Name
Service d’Hématologie
Principal Investigator Name
Laure Stalnikiewicz,
Principal Investigator Email
lstalnikiewicz@ch-lens.fr
Contact Person Name
Laure Stalnikiewicz,
Contact Person Email
lstalnikiewicz@ch-lens.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Service d’Hématologie-médecine interne
Principal Investigator Name
Patrice Chevallier,
Principal Investigator Email
patrice.chevallier@chu-nantes.fr
Contact Person Name
Patrice Chevallier,
Site Name
Centre Antoine Lacassagne
Department Name
Service d’Oncologie
Principal Investigator Name
Luca INCHIAPPA
Principal Investigator Email
nchiappal@ipc.unicancer.fr
Contact Person Name
Luca INCHIAPPA
Contact Person Email
nchiappal@ipc.unicancer.fr
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Service d’Hématologie
Principal Investigator Name
Victoria Cacheux
Principal Investigator Email
vcacheux@chu-clermontferrand.fr
Contact Person Name
Victoria Cacheux
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Service d’Hématologie
Principal Investigator Name
Anne Thiebaut
Principal Investigator Email
athiebautbertrand@chu-grenoble.fr
Contact Person Name
Anne Thiebaut
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Service d’Hématologie Clinique et Oncologie Médicale
Principal Investigator Name
Eric Jourdan,
Principal Investigator Email
eric.jourdan@chu-nimes.fr
Contact Person Name
Eric Jourdan,
Contact Person Email
eric.jourdan@chu-nimes.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Service d’Oncologie et Hématologie
Principal Investigator Name
Karin Bilger
Principal Investigator Email
karin.bilger@chru-strasbourg.fr
Contact Person Name
Karin Bilger
Site Name
Centre Hospitalier Victor Dupouy
Department Name
Service d’Hématologie
Principal Investigator Name
Ahmad AL JIJAKLI
Principal Investigator Email
ahmadkanj.aljijakli@ch-argenteuil.fr
Contact Person Name
Ahmad AL JIJAKLI
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Service Maladies du sang - Médecine interne
Principal Investigator Name
mathilde hunault
Principal Investigator Email
mahunault@chu-angers.fr
Contact Person Name
mathilde hunault
Contact Person Email
mahunault@chu-angers.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
cluzeau.t@chu-nice.fr
Principal Investigator Name
Thomas Cluzeau
Principal Investigator Email
laure-farnault@yahou.fr
Contact Person Name
Thomas Cluzeau
Contact Person Email
laure-farnault@yahou.fr
Site Name
CHU Besancon
Department Name
Service d’Hématologie
Principal Investigator Name
Marion Simonet-Boissard,
Principal Investigator Email
msimonet@chu-besancon.fr
Contact Person Name
Marion Simonet-Boissard,
Contact Person Email
msimonet@chu-besancon.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service d’Hématologie
Principal Investigator Name
Thibaut Leguay
Principal Investigator Email
thibaut.leguay@chu-bordeaux.fr
Contact Person Name
Thibaut Leguay
Contact Person Email
thibaut.leguay@chu-bordeaux.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Service d’Hématologie Clinique du Pr. Marolleau
Principal Investigator Name
Gaëlle Guillerm
Principal Investigator Email
gaelle.guillerm@chu-brest.fr
Contact Person Name
Gaëlle Guillerm
Contact Person Email
gaelle.guillerm@chu-brest.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Service d’Hématologie Clinique du Pr. Marolleau
Principal Investigator Name
Pascal Turlure
Principal Investigator Email
pascal.turlure@chu-limoges.fr
Contact Person Name
Pascal Turlure
Contact Person Email
pascal.turlure@chu-limoges.fr
Site Name
Centre Hospitalier Annecy Genevois
Department Name
Service d’Hématologie
Principal Investigator Name
Natasha Mauz
Principal Investigator Email
nmauz@ch-annecygenevois.fr
Contact Person Name
Natasha Mauz
Contact Person Email
nmauz@ch-annecygenevois.fr
Site Name
Centre Hospitalier Universitaire D Orleans
Department Name
Service d’Oncologie Médicale et Hématologie
Principal Investigator Name
Magda Alexis
Principal Investigator Email
magda.alexis@chr-orleans.fr
Contact Person Name
Magda Alexis
Contact Person Email
magda.alexis@chr-orleans.fr
Site Name
Centre Hospitalier De Colmar
Department Name
Service de Médecine B
Principal Investigator Name
Jacques Chapiro
Principal Investigator Email
jacques.chapiro@ch-colmar.fr
Contact Person Name
Jacques Chapiro
Contact Person Email
jacques.chapiro@ch-colmar.fr
Site Name
Centre Hospitalier Universitaire Reims
Department Name
Service d’Hématologie Clinique du Pr. Marolleau
Principal Investigator Name
Chantal Himberlin,
Principal Investigator Email
florence.pasquier@gustaveroussy.fr
Contact Person Name
Chantal Himberlin,
Site Name
Centre Hospitalier De Valenciennes
Department Name
Service d'Hématologie Clinique
Principal Investigator Name
Sabine Tricot,
Principal Investigator Email
tricot-s@ch-valenciennes.fr
Contact Person Name
Sabine Tricot,
Contact Person Email
tricot-s@ch-valenciennes.fr
Site Name
Centre Leon Berard
Department Name
Service d’Hématologie
Principal Investigator Name
Amine Belhabri
Principal Investigator Email
amine.belhabri@lyon.unicancer.fr
Contact Person Name
Amine Belhabri
Site Name
Institut Curie
Department Name
Service d’Onco-Hématologie
Principal Investigator Name
Jacques Vargaftig,
Principal Investigator Email
jacques.vargaftig@curie.fr
Contact Person Name
Jacques Vargaftig,
Contact Person Email
jacques.vargaftig@curie.fr

Belgium

Earliest CTIS Part Ii Submission Date
20-12-2024
Latest Decision Or Authorization Date
17-01-2025
Processing Time Days
28
Number Of Sites
7
Number Of Participants
200

Sites

Site Name
Grand Hopital De Charleroi
Department Name
onco-hematologie
Principal Investigator Name
Valérie Robin
Principal Investigator Email
valerie.robin@ghdc.be
Contact Person Name
Valérie Robin
Contact Person Email
valerie.robin@ghdc.be
Site Name
Institut Jules Bordet
Department Name
Hématologie
Principal Investigator Name
Sebastian Wittnebel
Principal Investigator Email
sebastian.wittnebel@bordet.be
Contact Person Name
Sebastian Wittnebel
Contact Person Email
sebastian.wittnebel@bordet.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Hématologie
Principal Investigator Name
Bernard De Prijck
Principal Investigator Email
bernard.deprijck@chu.ulg.ac.be
Contact Person Name
Bernard De Prijck
Contact Person Email
bernard.deprijck@chu.ulg.ac.be
Site Name
CHU De Charleroi Hopital Andre Vesale
Department Name
onco-hematologie
Principal Investigator Name
Agnes Triffet Agnes
Principal Investigator Email
agnes.triffet@chu-charleroi.be
Contact Person Name
Agnes Triffet Agnes
Contact Person Email
agnes.triffet@chu-charleroi.be
Site Name
CHU Helora
Department Name
Hématologie
Principal Investigator Name
Florence Van Obbergh
Principal Investigator Email
florence.vanobbergh@jolimont.be
Contact Person Name
Florence Van Obbergh
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Hématologie
Principal Investigator Name
Carlos Graux
Principal Investigator Email
carlos.graux@chuuclnamur.uclouvain.be
Contact Person Name
Carlos Graux
Site Name
Universite Catholique de Louvain
Department Name
Hématologie
Principal Investigator Name
Violaine Havelange
Principal Investigator Email
violaine.havelange@uclouvain.be
Contact Person Name
Violaine Havelange

Sponsor

Primary sponsor

Full Name
Assistance Publique Hopitaux De Paris
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

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