Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Bioequivalence study
Status
Ongoing, recruiting
Participants planned
42
Countries
1
Sites
10
Myelodysplastic Neoplasms (MDS) and Chronic Myelomonocytic Leukemia (CMML)
Key facts
- Sponsor
- Heidelberg University
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 3 Jul 2025 → ongoing
- Decision date (initial)
- 2025-04-29
- 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
Myelodysplastic Neoplasms (MDS) and Chronic Myelomonocytic Leukemia (CMML)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Heidelberg University
- Sponsor organisation
- Heidelberg University
- Address
- Seminarstrasse 2, Altstadt Altstadt
- City
- Heidelberg
- Postcode
- 69117
- Country
- Germany
Scientific contact point
- Organisation
- Heidelberg University
- Contact name
- Prof. Dr. med. Wolf-Karsten Hofmann
Public contact point
- Organisation
- Heidelberg University
- Contact name
- Prof. Dr. med. Wolf-Karsten Hofmann
Locations
1 EU/EEA country · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 42 | 10 |
| Rest of world | — | 0 | — |
Investigational sites
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Klinik und Poliklinik für Innere Medizin III, Ismaninger Strasse 22, Au-Haidhausen, Munich
Medizinische Hochschule Hannover
Abteilung für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Universitaetsmedizin Goettingen
Klinik für Hämatologie und Medizinische Onkologie, Robert-Koch-Strasse 40, Weende, Goettingen
Universitaetsklinikum Schleswig-Holstein AöR
Klinik für Hämatologie und Onkologie, Ratzeburger Allee 160, 23538, Luebeck
Heidelberg University
Medizinische Klinik für Hämatologie und Internistische Onkologie, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Universitaetsklinikum Duesseldorf AöR
Klinik für Hämatologie, Onkologie und Klinische Immunologie, Moorenstrasse 5, Bilk, Duesseldorf
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Medizinische Klinik und Poliklinik: Hämatologie und Medizinische Onkologie, Langenbeckstrasse 1, Oberstadt, Mainz
Universitaetsklinikum Bonn AöR
Medizinische Klinik III, Venusberg-Campus 1, Venusberg, Bonn
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Medizinische Klinik I, Early Clinical Trial Unit, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Klinikum Oldenburg AöR
Onkologie/Hämatologie, Rahel-Straus-Strasse 10, Kreyenbrueck, Oldenburg
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 | 2025-07-03 | 2025-09-02 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-30 | Germany | Acceptable 2025-04-02
|
2025-04-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-12-04 | Germany | Acceptable 2025-12-17
|
2025-12-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-04-01 | Germany | Acceptable 2026-04-27
|
2026-04-28 |