Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
24
Countries
1
Sites
3
Relapse/ refractory acute Leukemia
Key facts
- Sponsor
- Institut Paoli Calmettes
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 3 Jun 2020 → 24 Feb 2025
- Decision date (initial)
- 2024-12-04
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518265-10-01
- EudraCT number
- 2019-000814-13
- WHO UTN
- U1111-1313-4894
- ClinicalTrials.gov
- NCT03957915
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapse/ refractory acute Leukemia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10059034 | Acute myeloid leukaemia recurrent | 100000004864 |
| 21.1 | PT | 10067399 | Acute biphenotypic leukaemia | 100000004864 |
| 21.1 | LLT | 10081514 | Acute myeloid leukemia refractory | 10029104 |
| 20.1 | PT | 10063620 | Acute lymphocytic leukaemia recurrent | 100000004864 |
| 20.0 | PT | 10076866 | Acute lymphocytic leukaemia refractory | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institut Paoli Calmettes
- Sponsor organisation
- Institut Paoli Calmettes
- Address
- 232 Boulevard De Sainte Marguerite, Bp 156 Bp 156
- City
- Marseille
- Postcode
- 13009
- Country
- France
Scientific contact point
- Organisation
- Institut Paoli Calmettes
- Contact name
- Pr VEY Norbert
Public contact point
- Organisation
- Institut Paoli Calmettes
- Contact name
- Marina LAROSA
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 24 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Oncopole Claudius Regaud
Hématologie, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Institut Paoli Calmettes
Unités d'hématologie 2 et évaluation thérapeutique en Oncologie/hématologie, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
CHU de Bordeaux - Hôpital Haut-Lévêque
Hématologie clinique, 2 Avenue de Magellan, Centre Médico-Chirurgical Magellan, 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 | 2020-06-03 | 2025-02-24 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-05 | France | Acceptable 2024-11-27
|
2024-12-04 |