Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
105
Countries
2
Sites
5
Acute Myeloid Leukemia and Myelodysplastic Syndrome
Key facts
- Sponsor
- Bristol-Myers Squibb Services Unlimited Company
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 13 Mar 2026 → ongoing
- Decision date (initial)
- 2025-09-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519537-29-00
- WHO UTN
- U1111-1302-3713
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Acute Myeloid Leukemia and Myelodysplastic Syndrome
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10028533 | Myelodysplastic syndrome | 100000004864 |
| 21.0 | LLT | 10000886 | Acute myeloid leukemia | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bristol-Myers Squibb Services Unlimited Company
- Sponsor organisation
- Bristol-Myers Squibb Services Unlimited Company
- Address
- Plaza 254, Blanchardstown Corporate Park 2 Blanchardstown Corporate Park 2
- City
- Dublin 15
- Postcode
- D15 T867
- Country
- Ireland
Scientific contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Public contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Locations
2 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 21 | 3 |
| Spain | Authorised, recruiting | 14 | 2 |
| Rest of world
Canada, United States
|
— | 70 | — |
Investigational sites
Oncopole Claudius Regaud
Hématologie, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Institut Paoli Calmettes
Hématologie IPC4, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Assistance Publique Hopitaux De Paris
Hématologie, 1 Avenue Claude Vellefaux, 75010, Paris
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 |
|---|---|---|---|---|---|
| Spain | 2026-03-13 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-12 | France | Acceptable 2025-09-18
|
2025-09-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-07 | France | Acceptable 2025-12-16
|
2025-12-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-27 | France | Acceptable | 2026-04-20 |