Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
155
Countries
2
Sites
9
Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Types of Myelodysplastic Neoplasms
Key facts
- Sponsor
- Janssen Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 27 May 2025 → ongoing
- Decision date (initial)
- 2025-05-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Types of Myelodysplastic Neoplasms
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10081514 | Acute myeloid leukemia refractory | 10029104 |
| 27.0 | PT | 10028533 | Myelodysplastic syndrome | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Janssen Cilag International
- Sponsor organisation
- Janssen Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen Cilag International
- Contact name
- CTIS Point of Contact
Locations
2 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 31 | 6 |
| Spain | Ongoing, recruiting | 76 | 3 |
| Rest of world
Australia
|
— | 48 | — |
Investigational sites
Les Hopitaux Universitaires De Strasbourg
Hématologie, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Institut De Cancerologie Strasbourg Europe
Hématologie, 17 Rue Albert Calmette, 67200, Strasbourg
Hopital Saint Louis
Centre d'investigations cliniques, 1 Avenue Claude Vellefaux, 75010, Paris
Oncopole Claudius Regaud
Hématologie, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Institut Paoli Calmettes
Hématologie, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Les Hopitaux Universitaires De Strasbourg
Hématologie, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
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 | 2025-08-04 | 2025-08-04 | |||
| Spain | 2025-05-27 | 2025-05-27 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-10 | Spain | Acceptable 2025-04-29
|
2025-05-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-09 | Acceptable | 2025-08-26 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-10-06 | Acceptable | 2025-11-13 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-03-12 | Spain | Acceptable 2026-04-27
|
2026-04-28 |