Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
50
Countries
3
Sites
14
Diffuse large B-cell lymphoma (DLBCL), Grade 3B follicular lymphoma, High grade B-cell lymphoma (HGBL), Epstein-Barr virus−positive DLBCL
Key facts
- Sponsor
- F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 31 May 2021 → 22 May 2024
- Decision date (initial)
- 2024-03-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507497-40-00
- EudraCT number
- 2020-002376-12
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Diffuse large B-cell lymphoma (DLBCL), Grade 3B follicular lymphoma, High grade B-cell lymphoma (HGBL), Epstein-Barr virus−positive DLBCL
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10012818 | Diffuse large B-cell lymphoma | 100000004864 |
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
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
Locations
3 EU/EEA countries · 14 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 20 | 7 |
| Italy | Ended | 12 | 3 |
| Spain | Ended | 4 | 4 |
| Rest of world
United States
|
— | 14 | — |
Investigational sites
Centre Hospitalier Lyon Sud
Oncology Department, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Centre Hospitalier Universitaire De Montpellier
Oncology Department, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire De Rennes
Oncology Department, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire De Nantes
Oncology Department, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Lille
Oncology Department, Rue Michel Polonowski, 59000, Lille
Hopital Saint Louis
Oncology Department, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Henri Becquerel
Oncology Department, Rue D Amiens, 76038, Rouen Cedex
Azienda Unita Sanitaria Locale Della Romagna
Oncology and Haematology Department, Viale Vincenzo Randi 5, 48121, Ravenna
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Hematology-Oncology unit and Stem Cell Transplantation, Via Mariano Semmola 52, 80131, Naples
Azienda Ospedaliero Universitaria Pisana
Department of Clinical and Experimental Medicine, UO Hematology, Via Roma 67, 56126, Pisa
Hospital General Universitario Gregorio Maranon
Hematology and Hemotherapy, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital De La Santa Creu I Sant Pau
Clinical Hematology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Clinica Universidad De Navarra
Hematology and Hemotherapy, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitari Vall D Hebron
Hematology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
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 | 2021-05-31 | 2021-07-02 | 2023-06-26 | ||
| Italy | 2021-09-24 | 2021-11-04 | 2023-07-27 | ||
| Spain | 2021-06-29 | 2022-01-31 | 2023-02-10 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-15 | Italy | Acceptable 2024-03-04
|
2024-03-07 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-15 | Italy | Acceptable 2024-03-04
|
2024-03-15 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-05-16 | Italy | Acceptable 2024-03-04
|
2024-05-16 |