Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
24
Countries
1
Sites
1
Chronic Phase Chronic Myeloid Leukemia
Key facts
- Sponsor
- Mendus B.V.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 31 Mar 2026 → ongoing
- Decision date (initial)
- 2026-03-31
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Chronic Phase Chronic Myeloid Leukemia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.1 | LLT | 10052065 | Chronic phase chronic myeloid leukaemia | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Mendus B.V.
- Sponsor organisation
- Mendus B.V.
- Address
- Emmy Noetherweg 2 K
- City
- Leiden
- Postcode
- 2333 BK
- Country
- Netherlands
Scientific contact point
- Organisation
- Mendus B.V.
- Contact name
- Tariq Mughal
Public contact point
- Organisation
- Mendus B.V.
- Contact name
- Tariq Mughal
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ongoing, recruiting | 24 | 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 |
|---|---|---|---|---|---|
| Norway | 2026-03-31 | 2026-04-20 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-26 | Norway | Acceptable 2026-03-30
|
2026-03-31 |