Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
63
Countries
2
Sites
3
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
- 23 Oct 2019 → 22 May 2025
- Decision date (initial)
- 2024-07-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-512734-15-00
- EudraCT number
- 2018-003549-40
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
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 57 | 2 |
| Greece | Ended | 3 | 1 |
| Rest of world
Japan, United Kingdom
|
— | 3 | — |
Investigational sites
Hospices Civils De Lyon
Centre Hospitalier Lyon Sud Service d’Hématologie Clinique, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Universitaire De Lille
Hopital Claude Huriez - Service des maladies du sang, Rue Michel Polonowski, 59000, Lille
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 |
|---|---|---|---|---|---|
| France | 2019-10-23 | 2025-03-17 | 2019-11-07 | 2022-03-01 | |
| Greece | 2022-02-03 | 2025-02-27 | 2022-02-08 | 2022-03-24 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-08 | France | Acceptable 2024-07-05
|
2024-07-22 |