Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
40
Countries
3
Sites
8
Relapsed or Refractory Chronic Lymphocytic Leukemia (R/R CLL)
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
- 6 Oct 2025 → ongoing
- Decision date (initial)
- 2025-09-29
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed or Refractory Chronic Lymphocytic Leukemia (R/R CLL)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10008976 | Chronic lymphocytic leukemia | 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
Locations
3 EU/EEA countries · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 10 | 2 |
| Poland | Ongoing, recruiting | 7 | 3 |
| Spain | Authorised, recruiting | 5 | 3 |
| Rest of world
Australia, Israel, United States, New Zealand
|
— | 18 | — |
Investigational sites
University Hospital Of Clermont-Ferrand
Thérapie cellulaire et hématologie clinique, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand
Oncopole Claudius Regaud
Hématologie, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Oddział Wieloprofilowy Zachowawczy, Ul. Dra Kazimierza Jaczewskiego 8, 20-090, Lublin
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych, Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
Pratia S.A.
Pratia MCM Kraków, Ul. Pana Tadeusza 2, 30-727, Cracow
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 | 2026-05-05 | 2026-05-18 | |||
| Poland | 2025-10-06 | 2025-11-17 | |||
| Spain | 2025-11-12 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-FR-0001
- Member state
- France
- Publication date
- 2025-12-03
- Type
- 3
- Reason
- 7
- Immediate action required
- Yes
- Justification
- In line with the version 6.4 of CTR Q&A / point 1.23, the sponsor is requested to submit a specific SM Part II only in France in order to update its CTA in line with the documentation approved during the appeal procedure within 10 days after the submission of this corrective measure.
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-10 | Spain | Acceptable 2025-09-25
|
2025-09-25 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-02 | Spain | Acceptable 2025-09-25
|
2025-10-02 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-17 | Spain | Acceptable 2025-12-19
|
2025-11-21 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-23 | Acceptable | 2026-01-21 |