Status:
RECRUITING
Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
AbbVie
Collaborating Sponsors:
F. Hoffmann-La Roche Ltd; German CLL Study Group (GCLLSG); Dana-Farber Cancer Institute
Conditions:
Chronic Lymphocytic Leukemia (CLL)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess retreatment with venetoclax-obinutuzumab (VenG) in participants previousl...
Eligibility Criteria
Inclusion
- Documented diagnosis of chronic lymphocytic leukemia (CLL) that requires treatment for CLL according to International Workshop for Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria.
- Previously completed venetoclax + anti-CD20 antibody +/- X regimen as a fixed duration first-line (1L) therapy and achieved documented response, defined as complete remission, complete remission with incomplete marrow recovery, partial remission, or nodular partial remission.
- More than 24 months (Cohort 1) or 12-24 months (Cohort 2) have elapsed between last dose of venetoclax and disease progression after completion of 1L treatment.
Exclusion
- \- Received intervening treatment for CLL after completing previous treatment with a venetoclax + anti-CD20 antibody +/- X regimen.
Key Trial Info
Start Date :
March 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04895436
Start Date
March 28 2022
End Date
January 1 2029
Last Update
November 10 2025
Active Locations (57)
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1
Moores Cancer Center at UC San Diego /ID# 230157
La Jolla, California, United States, 92093
2
Winship Cancer Institute of Emory University /ID# 230643
Atlanta, Georgia, United States, 30322
3
Des Moines Oncology Research Association /ID# 232606
Des Moines, Iowa, United States, 50309-1423
4
Dana-Farber Cancer Institute /ID# 230061
Boston, Massachusetts, United States, 02215