Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
118
Countries
1
Sites
29
Primary Central Nervous System Lymphoma (PCNSL)
Key facts
- Sponsor
- Institut Curie
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15], Diseases [C] - Neoplasms [C04]
- Trial duration
- 30 Oct 2020 → ongoing
- Decision date (initial)
- 2024-10-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515331-30-00
- EudraCT number
- 2019-003632-23
- ClinicalTrials.gov
- NCT04446962
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Primary Central Nervous System Lymphoma (PCNSL)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut Curie
- Sponsor organisation
- Institut Curie
- Address
- 26 Rue D Ulm
- City
- Paris
- Postcode
- 75005
- Country
- France
Scientific contact point
- Organisation
- Institut Curie
- Contact name
- Carole Soussain
Public contact point
- Organisation
- Institut Curie
- Contact name
- Carole Soussain
Locations
1 EU/EEA country · 29 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 118 | 29 |
| Rest of world | — | 0 | — |
Investigational sites
Les Hopitaux Universitaires De Strasbourg
Hématologie, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
CHU Hôtel Dieu
Hématologie, 1 place Alexis-Ricordeau, 44093, Nantes Cedex 1
CHRU Jean Minjoz
Hématologie, 3 Boulevard Alexandre Fleming, 25030, Besançon
Hospital Claude Huriez
Maladies du Sang, 2 rue Michel Polonovski, 59037, Lille Cedex
Centre Hospitalier De La Cote Basque
Hématologie, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
Centre Hospitalier Universitaire De Poitiers
Hématologie et Thérapie Cellulaire, 2 Rue De La Miletrie, 86000, Poitiers
Hôpital Estaing - CHU de Clermont-Ferrand
Hématologie, 1 Rue Lucie et Raymond Aubrac, 63003, Clermont-Ferrand
CHU Dupuytren
Hématologie, 2, avenue Martin Luther King, Limosges
Centre Antoine Lacassagne
Oncologie Médicale, 33 Avenue De Valombrose, 06189, Nice Cedex 2
CHRU De Nancy
Neuro-oncologie, 29 Avenue Du Mal De Lattre De Tassigny, 54000, Nancy
Centre Hospitalier Universitaire De Toulouse
Hématologie, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Universitaire Amiens Picardie
Hématologie, 30 Avenue De La Croix Jourdain, 80054, Amiens Cedex 1
CHU Caen Normandie
Hématologie, Côte de Nacre, Hématologie, Caen
Centre Henri Becquerel
Hématologie, Rue D Amiens, 76038, Rouen Cedex
Hopital Henri Mondor - 1 rue Gustave Eiffel
Hémopathies Lymphoïdes, Av du Mal de Lattre de Tassigny, 94000, Créteil
CHU Grenoble Alpes - Hôpital Michallon
Hématologie, Boulevard de la Chantourne, 38700, La Tronche
Hoptial La Timone
Neuro-oncologie, 264 rue Saint Pierre, 13005, Marseille
CHU Rennes Pontchaillou Hospital
Hématologie, 2 Rue Henri Le Guilloux, 35033, Rennes Cedex 9
Hôpital de la Pitié Salpêtrière
Neurologie, 47-83 Bd de l'Hôpital, 75013, Paris
CHU Bretonneau
Hématologie, 2 boulevard Tonnelé, 37044, Tours
Hospices Civils De Lyon
Hématologie, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Assistance Publique Hopitaux de Paris – Hopital Cochin
Hématologie, 27 Rue du Faubourg Saint-Jacques, 75014, Paris
Centre Hospitalier Universitaire D'Angers
Maladies du Sang, 4 Rue Larrey, 49100, Angers
Centre Hospitalier De Colmar
Neurologie, 39 Avenue De La Liberte, Bp 60535, Colmar Cedex
Centre Hospitalier Universitaire De Dijon
Hématologie, 14 Rue Paul Gaffarel, 21000, Dijon
CHU Caremeau Service de Neurologie
Hématologie, CHU Caremeau, Service de Neurologie, Nîmes
CHU de La Réunion sites Sud
Onco-hématologie, Avenue François Mitterrand BP 350 97448 Saint-Pierre Cedex, France
Institut Curie
Hématologie, 35 Rue Dailly, 92210, Saint-Cloud
Institut Bergonié
Hématologie, 229 cours de l'Argonne, 33076, Bordeaux
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2020-10-30 | 2020-10-30 | 2024-08-20 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-03 | France | Acceptable 2024-10-29
|
2024-10-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-21 | France | Acceptable | 2025-03-12 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-08-29 | France | Acceptable | 2025-09-10 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-24 | France | Acceptable | 2026-03-23 |