Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
166
Countries
3
Sites
9
Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)
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
- 12 Sep 2022 → ongoing
- Decision date (initial)
- 2023-07-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-504187-42-00
- EudraCT number
- 2022-000685-18
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)
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
3 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruitment ended | 29 | 2 |
| France | Ongoing, recruitment ended | 18 | 5 |
| Poland | Ongoing, recruitment ended | 18 | 2 |
| Rest of world
Australia, United States, Japan, Israel, China
|
— | 101 | — |
Investigational sites
Odense University Hospital
Haematological Research unit HFE-X OUH, J B Winsloews Vej 4, 5000, Odense C
Rigshospitalet
Department of Haematology, Clinical Research Unit, 2081, Blegdamsvej 9, 2100, Copenhagen Oe
Institut Curie
Unité d’Investigation Clinique Adulte, 26 Rue D Ulm, 75005, Paris
Centre Hospitalier Universitaire De Lille
Hôpital Claude Huriez- Maladies du sang, Rue Michel Polonowski, 59000, Lille
Hopital Saint Eloi
Hôpital Saint Eloi Département d’Hématologie Clinique, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Institut Universitaire Du Cancer Toulouse-Oncopole
Institut Universitaire du Cancer I.U.C.Toulouse – Oncopôle Département Hématologie, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Institut De Cancerologie Strasbourg Europe
Hematology, 17 Rue Albert Calmette, 67200, Strasbourg
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 |
|---|---|---|---|---|---|
| Denmark | 2022-09-26 | 2022-10-11 | 2025-05-21 | ||
| France | 2022-09-12 | 2022-11-28 | 2025-05-21 | ||
| Poland | 2022-12-08 | 2022-12-20 | 2025-05-21 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-01 | Denmark | Acceptable 2023-07-12
|
2023-07-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-22 | Denmark | Acceptable 2023-12-12
|
2023-12-13 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-12-22 | Acceptable 2023-12-12
|
2023-12-22 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-01-10 | Acceptable | 2024-02-05 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-04-10 | Acceptable | 2024-06-28 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-07-16 | Denmark | Acceptable 2024-10-21
|
2024-10-21 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-11-04 | Denmark | Acceptable 2025-01-31
|
2025-01-31 |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-04-23 | Denmark | Acceptable 2025-07-08
|
2025-07-08 |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-08-29 | Denmark | Acceptable 2025-11-11
|
2025-11-11 |