Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
151
Countries
3
Sites
4
Relapsed/Refractory B-Cell Non-Hodgkin’s Lymphoma (r/r NHL)
Key facts
- Sponsor
- F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 3 Mar 2022 → 2 Aug 2024
- Decision date (initial)
- 2024-01-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506699-29-00
- EudraCT number
- 2021-003757-33
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed/Refractory B-Cell Non-Hodgkin’s Lymphoma (r/r NHL)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLGT | 10025320 | Lymphomas non-Hodgkin's B-cell | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Locations
3 EU/EEA countries · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 15 | 1 |
| France | Ended | 10 | 1 |
| Italy | Ended | 30 | 2 |
| Rest of world
United States, Australia, United Kingdom
|
— | 96 | — |
Investigational sites
Rigshospitalet
Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT, Blegdamsvej 9, 2100, Copenhagen Oe
Centre Hospitalier Universitaire De Lille
Pôle Spécialités Médicales et Oncologiques, 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 |
|---|---|---|---|---|---|
| Denmark | 2022-03-03 | 2024-08-01 | 2022-03-08 | 2024-06-10 | |
| France | 2022-06-22 | 2022-08-04 | 2024-06-10 | ||
| Italy | 2022-05-16 | 2022-05-26 | 2024-06-10 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-12 | Denmark | Acceptable 2024-01-26
|
2024-01-29 |