Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
29
Countries
1
Sites
1
Acute leukemia and myelodysplastic syndromes
Key facts
- Sponsor
- Institut Paoli Calmettes
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20], Diseases [C] - Neoplasms [C04]
- Trial duration
- 7 Oct 2024 → ongoing
- Decision date (initial)
- 2024-10-07
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515737-14-00
- EudraCT number
- 2016-004127-23
- WHO UTN
- U1111-1310-3269
- ClinicalTrials.gov
- NCT03235973
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Acute leukemia and myelodysplastic syndromes
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10028533 | Myelodysplastic syndrome | 100000004864 |
| 21.0 | LLT | 10000835 | Acute leukemia | 10029104 |
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
- Dr Raynier DEVILLIER
Public contact point
- Organisation
- Institut Paoli Calmettes
- Contact name
- Marina LAROSA
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 29 | 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 | 2024-10-07 | 2024-10-07 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-23 | France | Acceptable 2024-10-07
|
2024-10-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-11 | France | Acceptable 2026-04-03
|
2026-05-21 |