Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ended
Participants planned
35
Countries
1
Sites
2
Refractory Acute Myeloïd Leukemia
Key facts
- Sponsor
- Centre Leon Berard
- Participant type
- Patients
- Age range
- 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 8 Sep 2024 → 4 Jul 2025
- Decision date (initial)
- 2023-08-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Refractory Acute Myeloïd Leukemia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10000886 | Acute myeloid leukemia | 10029104 |
| 21.1 | LLT | 10081514 | Acute myeloid leukemia refractory | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Leon Berard
- Sponsor organisation
- Centre Leon Berard
- Address
- 28 Rue Laennec
- City
- Lyon
- Postcode
- 69008
- Country
- France
Scientific contact point
- Organisation
- Centre Leon Berard
- Contact name
- Oncology Doctor
Public contact point
- Organisation
- Centre Leon Berard
- Contact name
- Clinical Project Manager
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 35 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Leon Berard
Medical oncology, 28 Rue Laennec, 69008, Lyon
Hospices Civils De Lyon
Medical oncology, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
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 | 2024-09-08 | 2024-09-08 | 2025-02-18 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-17 | France | Acceptable 2023-08-25
|
2023-08-25 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-09-26 | France | Acceptable 2023-08-25
|
2023-09-26 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-27 | France | Acceptable | 2023-11-17 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-22 | France | Acceptable 2024-05-06
|
2024-05-29 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-04 | France | Acceptable 2024-05-06
|
2025-07-04 |