Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
36
Countries
2
Sites
4
non-Hodgkin lymphoma and chronic lymphocytic leukemia
Key facts
- Sponsor
- Janssen Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 16 Feb 2021 → 16 Jan 2025
- Decision date (initial)
- 2024-08-20
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-512687-66-00
- EudraCT number
- 2020-003149-12
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
non-Hodgkin lymphoma and chronic lymphocytic leukemia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10008976 | Chronic lymphocytic leukemia | 10029104 |
| 23.1 | LLT | 10084346 | B-cell non-Hodgkin´s lymphoma | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Janssen Cilag International
- Sponsor organisation
- Janssen Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen Cilag International
- Contact name
- CTIS Point of Contact
Locations
2 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 2 | 1 |
| Poland | Ended | 31 | 3 |
| Rest of world
Moldova, Republic of, Ukraine
|
— | 3 | — |
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 |
|---|---|---|---|---|---|
| Belgium | 2021-02-16 | 2025-01-13 | 2021-11-08 | 2022-03-15 | |
| Poland | 2021-03-02 | 2025-01-15 | 2021-03-10 | 2022-05-20 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-17 | Poland | Acceptable 2024-08-19
|
2024-08-20 |