Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
30
Countries
1
Sites
4
Subjects with AML ( Acute myeloid leukaemia) or MDS (Myelodysplastic syndrome) undergoing allogeneic hematopoietic stem cell transplantation
Key facts
- Sponsor
- Medac Gesellschaft fuer klinische Spezialpraeparate mbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 20 Dec 2022 → 23 Oct 2025
- Decision date (initial)
- 2024-10-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517377-24-00
- EudraCT number
- 2021-005433-16
- WHO UTN
- U1111-1311-8169
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Subjects with AML ( Acute myeloid leukaemia) or MDS (Myelodysplastic syndrome) undergoing allogeneic hematopoietic stem cell transplantation
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10000886 | Acute myeloid leukemia | 10029104 |
| 20.0 | LLT | 10068361 | MDS | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Medac Gesellschaft fuer klinische Spezialpraeparate mbH
- Sponsor organisation
- Medac Gesellschaft fuer klinische Spezialpraeparate mbH
- Address
- Theaterstr. 6
- City
- Wedel
- Postcode
- 22880
- Country
- Germany
Scientific contact point
- Organisation
- Medac Gesellschaft fuer klinische Spezialpraeparate mbH
- Contact name
- Clinical Trial Information
Public contact point
- Organisation
- Medac Gesellschaft fuer klinische Spezialpraeparate mbH
- Contact name
- Clinical Trial Information
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 30 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Universitaetsklinikum Essen AöR
Klinik für Hämatologie, Hufelandstrasse 55, Holsterhausen, Essen
Universitaet Muenster
Knochenmarktransplantationszentrum, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Universitaetsklinikum Schleswig-Holstein AöR
Klinik für Innere Medizin 2, Arnold-Heller-Strasse 3, Brunswik, Kiel
Technische Universitaet Dresden
Medizinische Klinik und Poliklinik I, Bereich Hemätologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
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 |
|---|---|---|---|---|---|
| Germany | 2022-12-20 | 2025-10-23 | 2022-12-20 | 2025-09-17 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-20 | Germany | Acceptable 2024-10-15
|
2024-10-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-28 | Germany | Acceptable 2025-04-16
|
2025-04-25 |