Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
10
Countries
1
Sites
5
hematologic malignancies ; acute myeloid leukemias
Key facts
- Sponsor
- Assistance Publique Hopitaux De Paris
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 17 Feb 2022 → ongoing
- Decision date (initial)
- 2024-08-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516104-42-00
- EudraCT number
- 2019-004883-23
- ClinicalTrials.gov
- NCT03879876
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
hematologic malignancies ; acute myeloid leukemias
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
- Pr Olivier Hermine
Public contact point
- Organisation
- Assistance Publique Hopitaux De Paris
- Contact name
- Pr Olivier Hermine
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 10 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
CHU De Bordeaux
33, 1 Rue Jean Burguet, Cs 11261, Bordeaux Cedex
Assistance Publique Hopitaux De Paris
75, Porte 23, 1 Avenue Claude Vellefaux, Paris Cedex 10
Assistance Publique Hopitaux De Paris
75, 149 Rue De Sevres, 75015, Paris
Centre Hospitalier Universitaire De Toulouse
31, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Institut Gustave Roussy
94, 114 Rue Edouard Vaillant, 94800, Villejuif
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 | 2022-02-17 | 2022-02-17 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-22 | France | Acceptable 2024-08-20
|
2024-08-20 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-11 | France | Acceptable 2024-08-20
|
2025-07-11 |