Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
40
Countries
2
Sites
10
Acute Myeloid Leukemia (AML)
Key facts
- Sponsor
- AvenCell Europe GmbH
- 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
- 28 Jan 2020 → 11 Apr 2025
- Decision date (initial)
- 2024-08-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515827-12-00
- EudraCT number
- 2019-001339-30
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Acute Myeloid Leukemia (AML)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AvenCell Europe GmbH
- Sponsor organisation
- AvenCell Europe GmbH
- Address
- Tatzberg 47, Johannstadt-Nord Johannstadt-Nord
- City
- Dresden
- Postcode
- 01307
- Country
- Germany
Scientific contact point
- Organisation
- AvenCell Europe GmbH
- Contact name
- Chief Scientific Officer
Public contact point
- Organisation
- AvenCell Europe GmbH
- Contact name
- Project Manager
Locations
2 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 35 | 8 |
| Netherlands | Ended | 5 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Klinikum der Universitaet Muenchen AöR
Medizinische Klinik und Poliklinik III, Marchioninistrasse 15, Hadern, Munich
Universitaetsklinikum Wuerzburg AöR
CCC Mainfranken, Interdisziplinäres Studienzentrum mit ECTU, Straubmuehlweg 2a, Grombuehl, Wuerzburg
University Medical Center Hamburg-Eppendorf
Zentrum für Onkologie Studienzentrale der II. Medizinischen Klinik, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Aachen AöR
Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation, Pauwelsstrasse 30, 52074, Aachen
Philipps-Universitaet Marburg
Klinik für Innere Medizin, Hämatologie, Onkologie, Immunologie, Baldingerstrasse, 35043, Marburg
Universitaet Leipzig
Klinik und Poliklinik für Hämatologie und Zelltherapie, Liebigstrasse 22, Zentrum-Suedost, Leipzig
Universitaetsklinikum Ulm AöR
Innere Medizin III (IM 3), Albert-Einstein-Allee 23, Eselsberg, Ulm
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Medizinische Klinik und Poliklinik I, Early Clinical Trial Unit, 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 | 2020-01-28 | 2020-03-03 | 2025-02-27 | ||
| Netherlands | 2022-11-02 | 2024-01-31 | 2025-02-27 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-04 | Germany | Acceptable with conditions 2024-08-01
|
2024-08-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-21 | Germany | Acceptable 2025-01-21
|
2025-01-21 |