Status:
COMPLETED
A Study of Ibrutinib in the Treatment of Chronic Lymphocytic Leukemia and Mantle-cell Lymphoma in Routine Clinical Practice
Lead Sponsor:
Janssen-Cilag Ltd.
Conditions:
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Mantle-Cell
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to describe the effectiveness of ibrutinib and to provide a description of ibrutinib therapy and the first non-ibrutinib subsequent therapy for chronic lymphocytic leukemi...
Eligibility Criteria
Inclusion
- Has a confirmed diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) or mantle-cell lymphoma (MCL), and is initiating ibrutinib therapy or has initiated ibrutinib therapy on or after 21 November 2014 (date of ibrutinib commercialization) for:
- treatment of CLL/SLL in participants who have received at least 1 prior therapy; or
- treatment in first line CLL/SLL participants in the presence of deletion (del) 17p or TP53 mutation in participants unsuitable for chemo-immunotherapy; or
- treatment of participants with relapsed or refractory MCL
- Not currently participating in another investigational study, clinical study, or any expanded access program at study entry
- Has not participated in the ibrutinib Autorisation Temporaire d'Utilisation (ATU) program
- Participant must sign a written informed consent form (ICF) allowing data collection and source data verification
Exclusion
- Currently participating in another investigational study, clinical study, or any expanded access program at study entry
- Participated in the ibrutinib Autorisation Temporaire d'Utilisation (ATU) program
Key Trial Info
Start Date :
May 11 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 11 2022
Estimated Enrollment :
508 Patients enrolled
Trial Details
Trial ID
NCT03425591
Start Date
May 11 2016
End Date
August 11 2022
Last Update
October 6 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Paris, France