Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
50
Countries
1
Sites
3
Acute Myeloid Leukemia
Key facts
- Sponsor
- OncoVerity Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 1 Jul 2020 → ongoing
- Decision date (initial)
- 2024-07-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-513276-17-00
- EudraCT number
- 2019-002808-41
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Acute Myeloid 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
OncoVerity Inc.
- Sponsor organisation
- OncoVerity Inc.
- Address
- 12635 East Montview Boulevard
- City
- Aurora
- Postcode
- 80045-7335
- Country
- United States
Scientific contact point
- Organisation
- OncoVerity Inc.
- Contact name
- OncoVerity Help Desk
Public contact point
- Organisation
- OncoVerity Inc.
- Contact name
- OncoVerity Help Desk
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 10 | 3 |
| Rest of world
Switzerland, United States, Canada
|
— | 40 | — |
Investigational sites
Universitaetsklinikum Leipzig AöR
Department of hematology, cell therapy and Hemostaseology, Johannisallee 32a, Zentrum-Suedost, Leipzig
University Medical Center Hamburg-Eppendorf
Internal medicine, Martinistrasse 52, Eppendorf, Hamburg
Klinikum der Universitaet Muenchen AöR
Gene Center Laboratory for Translational Cancer Immunology, Marchioninistrasse 15, Hadern, Munich
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 | 2020-07-01 | 2020-08-11 | 2020-12-13 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-05 | Germany | Acceptable with conditions 2024-07-17
|
2024-07-22 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-07 | Germany | Acceptable with conditions 2024-07-17
|
2024-08-07 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-11-07 | Germany | Acceptable with conditions 2024-07-17
|
2024-11-07 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-12 | Germany | Acceptable with conditions | 2025-01-17 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-04-29 | Germany | Acceptable with conditions | 2025-04-29 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-05-14 | Germany | Acceptable with conditions | 2026-05-14 |