Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Bioequivalence study
Status
Ongoing, recruitment ended
Participants planned
18
Countries
1
Sites
2
Mantle Cell Lymphoma
Key facts
- Sponsor
- Acerta Pharma B.V.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 5 Sep 2016 → ongoing
- Decision date (initial)
- 2024-07-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-509353-31-00
- EudraCT number
- 2015-004487-11
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Mantle Cell Lymphoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLT | 10026798 | Mantle cell lymphomas | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Acerta Pharma B.V.
- Sponsor organisation
- Acerta Pharma B.V.
- Address
- Kloosterstraat 9
- City
- Oss
- Postcode
- 5349 AB
- Country
- Netherlands
Scientific contact point
- Organisation
- Acerta Pharma B.V.
- Contact name
- Global Clinical Lead
Public contact point
- Organisation
- Acerta Pharma B.V.
- Contact name
- Global Clinical Lead
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ongoing, recruitment ended | 6 | 2 |
| Rest of world
United States
|
— | 12 | — |
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 |
|---|---|---|---|---|---|
| Poland | 2016-09-05 | 2016-10-25 | 2020-03-03 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-01 | Poland | Acceptable 2024-07-15
|
2024-07-29 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-04 | Poland | Acceptable 2024-07-15
|
2024-11-04 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-20 | Poland | Acceptable 2025-04-04
|
2025-04-09 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-24 | Poland | Acceptable 2025-09-08
|
2025-09-12 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-04-14 | Poland | Acceptable 2026-05-18
|
2026-05-25 |