Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
80
Countries
5
Sites
11
Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Key facts
- Sponsor
- 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
- 25 Jun 2021 → ongoing
- Decision date (initial)
- 2024-06-25
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507728-22-00
- EudraCT number
- 2021-000064-29
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.0 | LLT | 10086816 | B-cell non-Hodgkin´s lymphoma refractory | 100000004848 |
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
Locations
5 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 10 | 1 |
| Denmark | Ongoing, recruiting | 8 | 1 |
| Italy | Ongoing, recruiting | 24 | 2 |
| Poland | Ongoing, recruiting | 8 | 3 |
| Spain | Ongoing, recruiting | 23 | 4 |
| Rest of world
United States, Australia
|
— | 7 | — |
Investigational sites
Rigshospitalet
Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT, Blegdamsvej 9, 2100, Copenhagen Oe
Humanitas Mirasole S.p.A.
UOC Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
S.C. Ematologia, Piazza Oms 1, 24127, Bergamo
Uniwersytecki Szpital Kliniczny W Poznaniu
Oddzial Hematologii i Transplantacji Szpiku, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych, Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
Uniwersyteckie Centrum Kliniczne
Ośrodek Badań Klinicznych Faz Wczesnych, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Hospital Clinico Universitario De Valencia
Servicio de Hematologia, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Fundacion Jimenez Diaz
Servicio de Hematologia, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Clinic De Barcelona
Servicio de Hematologia, Calle Villarroel 170, 08036, Barcelona
Hospital Germans Trias I Pujol
Servicio de Hematologia, Carretera Canyet 1a Planta, 08916, Badalona
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 |
|---|---|---|---|---|---|
| Belgium | 2021-06-25 | 2021-07-27 | |||
| Denmark | 2021-09-28 | 2021-10-08 | |||
| Italy | 2021-09-21 | 2021-09-27 | |||
| Poland | 2021-11-17 | 2021-11-18 | |||
| Spain | 2021-08-12 | 2021-09-28 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-23 | Belgium | Acceptable 2024-06-25
|
2024-06-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-12 | Belgium | Acceptable 2025-04-30
|
2025-04-30 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-17 | Belgium | Acceptable 2025-04-30
|
2025-06-17 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-08-12 | Belgium | Acceptable 2025-04-30
|
2025-08-12 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-11-20 | Belgium | Acceptable with conditions 2026-02-10
|
2026-02-10 |