Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
12
Countries
1
Sites
1
adult patients with acute myeloblastic leukemia (AML) of poor prognosis first Line or Relapse
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
- 13 Mar 2023 → ongoing
- Decision date (initial)
- 2022-11-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
adult patients with acute myeloblastic leukemia (AML) of poor prognosis first Line or Relapse
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Nantes
- Sponsor organisation
- Centre Hospitalier Universitaire De Nantes
- Address
- 5 Allee De L Ile Gloriette, Cs 69301 Cs 69301
- City
- Nantes Cedex 1
- Postcode
- 44093
- 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 · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 12 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 | 2023-03-13 | 2023-03-16 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-08-31 | France | Acceptable 2022-11-28
|
2022-11-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-03-15 | France | Acceptable 2023-04-21
|
2023-04-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-24 | France | Acceptable 2025-03-19
|
2025-04-02 |