Status:
RECRUITING
A Study to Evaluate the Effect of Venetoclax on Participants Receiving a Covalent Bruton's Tyrosine Kinase Inhibitor (cBTKi) for First-line Chronic Lymphocytic Leukemia (1L CLL) to Achieve Deep Durable Remissions to Allow Off-treatment Period.
Lead Sponsor:
Genentech, Inc.
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The main purpose of the study is to evaluate if adding venetoclax to participants receiving cBTKi for the 1L CLL can achieve deep durable remissions of undetectable measurable residual disease \[uMRD ...
Eligibility Criteria
Inclusion
- Diagnosed with CLL and currently receiving a stable dose of cBTKi (i.e., ibrutinib, acalabrutinib, or zanubrutinib) for at least 6 months for 1L treatment with a response of at least a PR per iwCLL criteria
- Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to (\</=) 2
- Adequate renal and liver function
Exclusion
- Prior B-cell lymphoma (Bcl-2) inhibitor therapy
- Anti-cluster of differentiation 20 (CD20) therapy within the month prior to screening
- Progressive or stable disease on cBTKi
- Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (Richter's transformation or pro-lymphocytic leukemia)
- History of cardiomyopathy
- Hypersensitivity to venetoclax or to any of the excipients (e.g., trehalose)
- Clinically significant cardiovascular disease
- Active bleeding or history of bleeding diathesis
- Pregnant women and nursing mothers
- Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
Key Trial Info
Start Date :
August 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 8 2028
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06524375
Start Date
August 9 2024
End Date
February 8 2028
Last Update
October 14 2025
Active Locations (21)
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1
Highlands Oncology Group
Springdale, Arkansas, United States, 72762
2
Rocky Mountain Cancer Centers (Aurora) - USOR
Aurora, Colorado, United States, 80012-5405
3
Cancer Specialists of North Florida
Jacksonville, Florida, United States, 32256-6932
4
University Cancer & Blood Center, LLC
Athens, Georgia, United States, 30607