Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
41
Countries
1
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
- 28 Jan 2021 → 28 May 2025
- Decision date (initial)
- 2024-07-09
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-512686-13-00
- EudraCT number
- 2019-003194-25
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 |
|---|---|---|---|---|
| 23.1 | LLT | 10084346 | B-cell non-Hodgkin´s lymphoma | 100000004848 |
| 21.0 | LLT | 10008976 | Chronic lymphocytic leukemia | 10029104 |
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
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ended | 16 | 4 |
| Rest of world
United States, Ukraine, Moldova, Republic of, Taiwan, Georgia, United Kingdom
|
— | 25 | — |
Investigational sites
Uniwersyteckie Centrum Kliniczne
Uniwersyteckie Centrum Kliniczne, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Pratia S.A.
Pratia MCM, Ul. Pana Tadeusza 2, 30-727, Cracow
Pratia Hematologia Sp. z o.o.
Pratia Hematologia Sp. z o.o., Ul. Tadeusza Kosciuszki 92, 40-519, Katowice
Pratia S.A.
Centrum Medyczne Pratia Poznan, Ul. Poznanska 14, 60-185, Skorzewo
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 | 2021-01-28 | 2025-01-29 | 2021-01-28 | 2023-03-07 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-13 | Poland | Acceptable 2024-07-05
|
2024-07-09 |