Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
114
Countries
1
Sites
26
elderly patients (> = 60 years) with Acute Myeloid Leukemia
Key facts
- Sponsor
- French Innovative Leukemia Organization
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 25 May 2022 → 5 Jan 2026
- Decision date (initial)
- 2024-07-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-502392-37-00
- EudraCT number
- 2020-005866-32
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
elderly patients (> = 60 years) with Acute Myeloid Leukemia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10000880 | Acute myeloid leukaemia | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
French Innovative Leukemia Organization
- Sponsor organisation
- French Innovative Leukemia Organization
- Address
- 2 Boulevard Tonnelle
- City
- Tours
- Postcode
- 37000
- Country
- France
Scientific contact point
- Organisation
- French Innovative Leukemia Organization
- Contact name
- Pr PIGNEUX
Public contact point
- Organisation
- French Innovative Leukemia Organization
- Contact name
- Secrétariat du FILO
Locations
1 EU/EEA country · 26 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 114 | 26 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Rennes
Hematologie Clinique, 2 Rue Henri Le Guilloux, 35033, Rennes Cedex 9
Centre Hospitalier Universitaire De Reims
Hématologie Clinique - Unité 43, Rue Du General Koenig, 51092, Reims Cedex
Centre Leon Berard
Hematologie, 28 Rue Laennec, 69008, Lyon
Centre Hospitalier Annecy Genevois
Hématologie Clinique, 1 Avenue De L Hopital, Bp 90074 Epagny Metz Tessy, Pringy Cedex
Centre Hospitalier Universitaire De Bordeaux
Service d'Hématologie Clinique et Thérapie Cellulaire, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Regional Universitaire De Tours
Centre H. Kaplan - Service Hématologie Clinique et Thérapie Cellulaire, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
Centre Hospitalier Universitaire De Nantes
Service d'Hématologie clinique, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Nimes
Hématologie Clinique et Oncologie Médicale, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
Hopital Saint Eloi
HEMATOLOGIE CLINIQUE, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire De Toulouse
"Essais cliniques Service hémtologie", 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Besancon University Hospital Center
Service Hématologie, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
CHRU De Nancy
HEMATOLOGIE ADULTE - 7eme ETAGE, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
University Hospital Of Clermont-Ferrand
Service Hématologie Clinique Adulte et Thérapie Cellulaire, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand
Centre Hospitalier D Avignon
ONCO - HEMATOLOGIE, 305 Rue Raoul Follereau, 84000, Avignon
Centre Hospital Region Metz Thionville
Service Hématologie, 1 Allee Du Chateau, Cs 45001 Ars Laquenexy, Metz Cedex 03
Centre Hospitalier De Perpignan
Service Hématologie, 20 Avenue Du Languedoc, Cs 49954, Perpignan Cedex
Centre Hospitalier De La Cote Basque
Service Hématologie, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
Centre Hospitalier Regional D'orleans
Service d'Hématologie, 14 Avenue De L Hopital, Cs 86709, Orleans Cedex 2
Centre Hospitalier Universitaire D Angers
Service Maladies du sang, 4 Rue Larrey, 49933, Angers Cedex 9
Centre Hospitalier Universitaire Grenoble Alpes
Service Hématologie - 6ème étage, Boulevard De La Chantourne, Cs 10217 La Tronche, Grenoble Cedex 9
Institut Paoli-Calmettes
Service Hématologie, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Hospitalier De Beziers
Service d'Hématologie, Zone Dactivite Montimaran, 2 Rue Valentin Hauy, Beziers
Institut De Cancerologie Strasbourg Europe
Service Hematologie, 17 Rue Albert Calmette, 67200, Strasbourg
Chu De Saint Etienne
Service Hématologie, 25 Boulevard Pasteur, 42055, Saint-Etienne Cedex 2
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace
Service d'Hématologie, 87 Avenue D Altkirch, 68100, Mulhouse
Les Hopitaux Universitaires De Strasbourg
Service Hematologie, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
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 | 2022-05-25 | 2026-01-05 | 2022-05-25 | 2023-09-21 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-05 | France | Acceptable 2024-07-19
|
2024-07-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-30 | France | Acceptable 2024-08-05
|
2024-08-05 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-06 | France | Acceptable 2024-08-05
|
2025-03-06 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-22 | France | Acceptable 2025-07-17
|
2025-07-18 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-25 | France | Acceptable | 2025-09-16 |