Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Authorised, recruitment pending
Participants planned
26
Countries
1
Sites
2
Relapsed and/or refractory AML or MDS
Key facts
- Sponsor
- Karolinska Institutet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Decision date (initial)
- 2026-01-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed and/or refractory AML or MDS
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Karolinska Institutet
- Sponsor organisation
- Karolinska Institutet
- Address
- Alfred Nobels Alle 8, Flemingsberg Flemingsberg
- City
- Huddinge
- Postcode
- 141 52
- Country
- Sweden
Scientific contact point
- Organisation
- Karolinska Institutet
- Contact name
- Karl-Johan Malmberg
Public contact point
- Organisation
- Karolinska Institutet
- Contact name
- Andreas Björklund
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Authorised, recruitment pending | 26 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-24 | Sweden | Acceptable with conditions 2026-01-19
|
2026-01-19 |