Clinical trial • Phase I/II • Oncology|Haematology

Lenalidomide for Primary central nervous system lymphoma

Phase I/II trial of Lenalidomide for Primary central nervous system lymphoma. Randomised, adaptive. 118 participants.

Overview

Trial Therapeutic Area
Oncology|Haematology
Trial Disease
Primary central nervous system lymphoma
Trial Stage
Phase I/II
Drug Modality
Small molecule|Monoclonal antibody

Key dates

Initial CTIS Submission Date
03-09-2024
First CTIS Authorization Date
29-10-2024

Trial design

Randomised, adaptive Phase I/II trial across 29 sites in France.

Randomised
Yes
Adaptive
True, dose-escalation in phase IB of lenalidomide and ibrutinib; specific escalation rules not provided in the CTIS record
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
118

Eligibility

Recruits 118 No vulnerable population selected; consent/assent handling not specified..

Vulnerable Population
No vulnerable population selected; consent/assent handling not specified.

Recruitment

Planned Sample Size
118
Recruitment Window Months
168

Geography

Total Number Of Sites
29
Total Number Of Participants
118

France

Earliest CTIS Part Ii Submission Date
01-07-2024
Latest Decision Or Authorization Date
23-03-2026
Processing Time Days
631
Number Of Sites
29
Number Of Participants
118

Sites

Site Name
CHU Caremeau Service de Neurologie
Department Name
Hématologie
Contact Person Name
Agathe WAULTIER RASCALOU
Site Name
Hospital Claude Huriez
Department Name
Maladies du Sang
Contact Person Name
Franck MORSCHHAUSER
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Hématologie
Contact Person Name
Luc-Matthieu FORNECKER
Contact Person Email
lm.fornecker@icans.eu
Site Name
Hôpital Estaing - CHU de Clermont-Ferrand
Department Name
Hématologie
Contact Person Name
Cécile MOLUCON-CHABROT
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Hématologie
Contact Person Name
Olivier CASASNOVAS
Site Name
CHU Caen Normandie
Department Name
Hématologie
Contact Person Name
Gandhi DAMAJ
Contact Person Email
damaj-gl@chu-caen.fr
Site Name
Hoptial La Timone
Department Name
Neuro-oncologie
Contact Person Name
Olivier CHINOT
Contact Person Email
olivier.chinot@ap-hm.fr
Site Name
CHU de La Réunion sites Sud
Department Name
Onco-hématologie
Contact Person Name
Marie DE CHARETTE
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Hématologie
Contact Person Name
Kossi AGBETIAFA
Contact Person Email
Agbetiafia.kossi@chu-amiens.fr
Site Name
CHU Hôtel Dieu
Department Name
Hématologie
Contact Person Name
Thomas GASTINNE
Contact Person Email
thomas.gastinne@chu-nantes.fr
Site Name
CHU Grenoble Alpes - Hôpital Michallon
Department Name
Hématologie
Contact Person Name
Rémy GRESSIN
Contact Person Email
RGressin@chu-grenoble.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Maladies du Sang
Contact Person Name
Jérôme PAILLASSA
Contact Person Email
jpaillassa@chu-angers.fr
Site Name
CHU Dupuytren
Department Name
Hématologie
Contact Person Name
Julie ABRAHAM
Contact Person Email
julie.abraham@chu-limoges.fr
Site Name
Assistance Publique Hopitaux de Paris – Hopital Cochin
Department Name
Hématologie
Contact Person Name
Lise WILLEMS
Contact Person Email
lise.willems@aphp.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Hématologie et Thérapie Cellulaire
Contact Person Name
Vincent DELWAIL
Site Name
Centre Hospitalier De Colmar
Department Name
Neurologie
Contact Person Name
Guido AHLE
Contact Person Email
guido.ahle@ch-colmar.fr
Site Name
Hospices Civils De Lyon
Department Name
Hématologie
Contact Person Name
Hervé GHESQUIERES
Contact Person Email
herve.ghesquieres@chu-lyon.fr
Site Name
Hôpital de la Pitié Salpêtrière
Department Name
Neurologie
Contact Person Name
Caroline HOUILLIER
Contact Person Email
caroline.houillier@aphp.fr0142
Site Name
Centre Hospitalier De La Cote Basque
Department Name
Hématologie
Contact Person Name
Sophie BERNARD
Contact Person Email
sbernard@ch-cotebasque.fr
Site Name
Hopital Henri Mondor - 1 rue Gustave Eiffel
Department Name
Hémopathies Lymphoïdes
Contact Person Name
Louise ROULIN
Contact Person Email
louise.roulin@aphp.fr
Site Name
CHRU Jean Minjoz
Department Name
Hématologie
Contact Person Name
Adrien CHAUCHET
Contact Person Email
achauchet@chu-besancon.fr
Site Name
Institut Bergonié
Department Name
Hématologie
Contact Person Name
Anna SCHMITT
Site Name
Centre Antoine Lacassagne
Department Name
Oncologie Médicale
Contact Person Name
Frédéric PEYRADE
Site Name
Centre Henri Becquerel
Department Name
Hématologie
Contact Person Name
Fabrice JARDIN
Site Name
Institut Curie
Department Name
Hématologie
Contact Person Name
Steven Le GOUILL
Contact Person Email
drci.promotion@curie.fr
Site Name
CHU Bretonneau
Department Name
Hématologie
Contact Person Name
Emmanuel GYAN
Contact Person Email
emmanuel.gyan@univ-tours.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Hématologie
Contact Person Name
Lucie OBERIC
Contact Person Email
oberic.lucie@iuct-oncopole.fr
Site Name
CHRU De Nancy
Department Name
Neuro-oncologie
Contact Person Name
Luc TAILLANDIER
Contact Person Email
l.taillandier@chu-nancy.fr
Site Name
CHU Rennes Pontchaillou Hospital
Department Name
Hématologie
Contact Person Name
Thierry LAMY De La CHAPELLE
Contact Person Email
thierry.lamy@univ-rennes1.fr

Sponsor

Primary sponsor

Full Name
Institut Curie
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
Lenalidomide
Active Substance
Lenalidomide
Modality
Small molecule
Investigational Product Name
Ibrutinib
Active Substance
Ibrutinib
Modality
Small molecule
Combination Treatment
Yes

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