Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
40
Countries
1
Sites
5
Relapsed/Refractory B-cell Non-Hodgkin Lymphoid Malignancies
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 Dec 2024 → ongoing
- Decision date (initial)
- 2024-10-31
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed/Refractory B-cell Non-Hodgkin Lymphoid Malignancies
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.0 | PT | 10029547 | Non-Hodgkin's lymphoma | 100000004864 |
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 · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruitment ended | 16 | 5 |
| Rest of world
Australia, United Kingdom, Taiwan
|
— | 24 | — |
Investigational sites
Hospital General Universitario Gregorio Maranon
Hematology, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital Clinic De Barcelona
Hematology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitari Vall D Hebron
Hematology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario 12 De Octubre
Hematology, Bloque D, Avenida De Cordoba Sn, Madrid
Institut Catala D'oncologia
Hematology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
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 |
|---|---|---|---|---|---|
| Spain | 2024-12-16 | 2024-12-16 | 2025-10-28 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-01 | Spain | Acceptable 2024-10-31
|
2024-10-31 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-13 | Spain | Acceptable 2025-02-27
|
2025-02-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-03 | Spain | Acceptable 2025-10-21
|
2025-10-24 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-11 | Spain | Acceptable | 2025-11-21 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-13 | Spain | Acceptable | 2026-01-13 |