Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
64
Countries
5
Sites
13
Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (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
- 17 Jun 2022 → ongoing
- Decision date (initial)
- 2023-04-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-501876-24-00
- EudraCT number
- 2021-000846-16
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10008976 | Chronic lymphocytic leukemia | 10029104 |
| 21.1 | LLT | 10008978 | Chronic lymphocytic leukemia refractory | 10029104 |
| 21.1 | LLT | 10008977 | Chronic lymphocytic leukemia recurrent | 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 Town
- 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 · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 6 | 2 |
| Germany | Ongoing, recruiting | 8 | 2 |
| Italy | Ongoing, recruiting | 12 | 4 |
| Poland | Ongoing, recruiting | 20 | 3 |
| Spain | Ongoing, recruiting | 8 | 2 |
| Rest of world
United States, United Kingdom, Australia
|
— | 10 | — |
Investigational sites
Institut Claudius Regaud
Hematology, 1 Avenue Irene Joliot Curie, 31100, Toulouse
University Hospital Of Clermont-Ferrand
Hematology, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand
University Hospital Augsburg
II, Stenglinstrasse 2, Kriegshaber, Augsburg
Universitaetsklinikum Ulm AöR
Innere Medizin III, Albert-Einstein-Allee 23, Eselsberg, Ulm
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
UOC Ematologia, Piazzale Spedali Civili 1, 25123, Brescia
Ospedale San Raffaele S.r.l.
Programma di ricerca strategica sulla LLC, Via Olgettina 60, 20132, Milan
ASST Grande Ospedale Metropolitano Niguarda
SC Ematologia - Dip. di Ematologia e Oncologia, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Hospital Santa Maria Della Misericordia
Ematologia e Trapianto Midollo Osseo, Piazzale Giorgio Menghini 1, 06129, Perugia
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, Ul. Pana Tadeusza 2, 30-727, Cracow
Centrum Wsparcia Badań Klinicznych UCK Ośrodek Badań Klinicznych Wczesnych Faz
Ośrodek Badań Klinicznych Wczesnych Faz, Smoluchowskiego 17, 80- 211, Gdansk
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 | 2022-06-17 | ||||
| Germany | 2022-05-16 | 2024-10-17 | |||
| Italy | 2022-01-13 | 2022-03-16 | |||
| Poland | 2025-09-16 | 2025-09-24 | |||
| Spain | 2021-11-02 | 2022-02-21 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 4 · Art. 38 CTR
Temporary halt TH-23062
- Halt date
- 2023-07-03
- Member states concerned
- Spain
- Publication date
- 2024-04-25
- Reason
- Sponsor decision
- Explanation
- The IMC members agree with proceeding to the dose escalation phase of the BO43243 study, however, despite the committee’s decision, the Study Leadership Team (SLT) has taken the decision to temporarily halt enrollment until a new protocol amendment (v4) incorporating changes in the dosing regimen is approved.
- Follow-up measures
- One patient (006) remains on study and on treatment, following the current protocol (v3)
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-5141
- Halt date
- 2023-07-03
- Planned restart
- 2023-11-01
- Member states concerned
- France
- Publication date
- 2023-09-20
- Reason
- Sponsor decision
- Explanation
- The IMC members agree with proceeding to the dose escalation phase of the BO43243 study, however, despite the committee’s decision, the Study Leadership Team (SLT) has taken the decision to temporarily halt enrollment until a new protocol amendment (v4) incorporating changes in the dosing regimen is approved.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-3140
- Halt date
- 2023-07-03
- Planned restart
- 2023-11-01
- Member states concerned
- Italy
- Publication date
- 2023-07-20
- Reason
- Sponsor decision
- Explanation
- The IMC members agree with proceeding to the dose escalation phase of the BO43243 study, however, despite the committee’s decision, the Study Leadership Team (SLT) has taken the decision to temporarily halt enrollment until a new protocol amendment (v4) incorporating changes in the dosing regimen is approved.
- Follow-up measures
- One patient (006) remains on study and on treatment, following the current protocol (v3)
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-3141
- Halt date
- 2023-07-03
- Planned restart
- 2023-11-01
- Member states concerned
- Germany
- Publication date
- 2023-07-20
- Reason
- Sponsor decision
- Explanation
- The IMC members agree with proceeding to the dose escalation phase of the BO43243 study, however, despite the committee’s decision, the Study Leadership Team (SLT) has taken the decision to temporarily halt enrollment until a new protocol amendment (v4) incorporating changes in the dosing regimen is approved.
- Follow-up measures
- One patient (006) remains on study and on treatment, following the current protocol (v3)
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-02-16 | Spain | Acceptable 2023-04-11
|
2023-04-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-06-20 | Spain | Acceptable 2023-08-01
|
2023-08-01 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-08-10 | Acceptable | 2023-09-18 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-12-05 | Spain | Acceptable 2024-03-14
|
2024-03-14 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-05-31 | Spain | Acceptable 2024-07-09
|
2024-07-09 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-10-10 | Spain | Acceptable 2024-11-28
|
2024-11-28 |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-01-30 | Spain | Acceptable 2025-04-25
|
2025-04-25 |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2025-05-19 | Acceptable 2025-04-25
|
2025-08-18 | |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-08-21 | Acceptable 2025-04-25
|
2025-08-21 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-09-26 | Spain | Acceptable 2025-11-25
|
2025-11-28 |