Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Authorised, recruitment pending
Participants planned
36
Countries
1
Sites
6
Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)
Key facts
- Sponsor
- Assistance Publique Hopitaux De Paris
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify, Diseases [C] - Hemic and Lymphatic Diseases [C15], Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-06-10
- 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
Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Assistance Publique Hopitaux De Paris
- Sponsor organisation
- Assistance Publique Hopitaux De Paris
- Address
- Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux
- City
- Paris Cedex 10
- Postcode
- 75475
- Country
- France
Scientific contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Dr Sofiane Fodil
Public contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Dr Sofiane Fodil
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 36 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Institut Gustave Roussy
Hematology, 39 Rue Camille Desmoulins, 94805, Villejuif Cedex
Assistance Publique Hopitaux De Paris
Hematology, 1 Avenue Claude Vellefaux, 75010, Paris
Institut Paoli Calmettes
Hematology, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Assistance Publique Hopitaux De Paris
Clinical Hematology, 125 Rue De Stalingrad, 93000, Bobigny
Centre Hospitalier Universitaire De Nice
Hematology, 151 Route De Saint Antoine, 06200, Nice
Assistance Publique Hopitaux De Paris
Hematology, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-04-16 | France | Acceptable 2026-06-04
|
2026-06-10 |