Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
21
Countries
1
Sites
8
Acute 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
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 22 Oct 2024 → ongoing
- Decision date (initial)
- 2024-03-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-501019-15-00
- ClinicalTrials.gov
- NCT06356922
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Acute 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
- Pr Patrice CHEVALLIER
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nantes
- Contact name
- Pr Patrice CHEVALLIER
Locations
1 EU/EEA country · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 21 | 8 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Nantes
Médecine Nucleaire, 5 Allee De L Ile Gloriette, Cs 69301, Nantes Cedex 1
University Hospital Of Clermont-Ferrand
Hématologie, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand
Centre Hospitalier Universitaire D'Angers
Hématologie, 4 Rue Larrey, 49100, Angers
University Hospital Of Clermont-Ferrand
Médecine Nucleaire, 58 Rue Montalembert, 63003, Clermont Ferrand Cedex 1
Centre Hospitalier Universitaire De Bordeaux
Hématologie, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire De Nantes
Hématologie, 5 Allee De L Ile Gloriette, Cs 69301, Nantes Cedex 1
Centre Hospitalier Universitaire D'Angers
Médecine Nucleaire, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Universitaire De Bordeaux
Médecine Nucleaire, Avenue De Magellan, 33600, Pessac
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 | 2024-10-22 | 2024-10-22 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-21 | France | Acceptable 2024-03-25
|
2024-03-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-02 | France | Acceptable 2024-07-25
|
2024-07-25 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-21 | France | Acceptable 2025-02-18
|
2025-02-19 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-02 | France | Acceptable 2025-07-22
|
2025-08-12 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-20 | France | Acceptable 2025-12-18
|
2025-12-18 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-15 | France | Acceptable 2025-12-18
|
2026-04-15 |