Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
12
Countries
1
Sites
3
Adult patients with adverse Risk Acute Myeloblastic Leukemia
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Nantes
- 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
- 6 Feb 2025 → ongoing
- Decision date (initial)
- 2023-02-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Adult patients with adverse Risk Acute Myeloblastic Leukemia
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Nantes
- Sponsor organisation
- Centre Hospitalier Universitaire De Nantes
- Address
- 1 Place Alexis Ricordeau
- City
- Nantes
- Postcode
- 44000
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Nantes
- Contact name
- Pierre PETERLIN
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nantes
- Contact name
- Pierre PETERLIN
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 12 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Rennes
Service d'hématologie clinique, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire De Nantes
service d'hématologie clinique, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire D Angers
Service d'hématologie clinique, 4 Rue Larrey, 49933, Angers Cedex 9
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 | 2025-02-06 | 2025-02-06 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-11-16 | France | Acceptable 2023-02-07
|
2023-02-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-04-17 | France | Acceptable 2023-05-26
|
2023-05-30 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-09 | France | Acceptable 2024-07-30
|
2024-07-30 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-01-21 | France | Acceptable 2025-02-12
|
2025-02-19 |