Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
20
Countries
1
Sites
1
acute myeolic leukemia
Key facts
- Sponsor
- Universitaetsklinikum Tuebingen AöR
- 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
- 10 Jun 2024 → ongoing
- Decision date (initial)
- 2024-04-18
- 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
acute myeolic leukemia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10000886 | Acute myeloid leukemia | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaetsklinikum Tuebingen AöR
- Sponsor organisation
- Universitaetsklinikum Tuebingen AöR
- Address
- Otfried-Mueller-Strasse 10, Nordstadt Nordstadt
- City
- Tuebingen
- Postcode
- 72076
- Country
- Germany
Scientific contact point
- Organisation
- Universitaetsklinikum Tuebingen AöR
- Contact name
- Prof. Dr.Juliane Walz
Public contact point
- Organisation
- Universitaetsklinikum Tuebingen AöR
- Contact name
- Prof. Dr.Juliane Walz
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 | 2024-06-10 | 2024-08-14 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-31 | Germany | Acceptable 2024-04-17
|
2024-04-18 |