Chronic Lymphocytic Leukemia Clinical Trial
Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With CLL
Summary
A Phase 2 study of Zandelisib with Venetoclax (VEN) and Rituximab (R) in subjects with Relapsed/Refractory leukemia-cll/" >CLL.
Full Description
This is an open label Phase 2 clinical study of Zandelisib with Venetoclax (VEN) and Rituximab (R) in subjects with R/R CLL.
VEN and R will be administered per standard of care.
Subjects must have histologically confirmed relapsed/refractory CLL and received ≥1 lines of prior therapy
A total 42 subjects will be enrolled and treated with zandelisib in combination with VEN + R.
Eligibility Criteria
Inclusion Criteria:
Males or females ≥18 years
Histologically confirmed relapsed/refractory CLL who received ≥1 lines of prior therapy
At least one bi-dimensionally measurable nodal lesion >1.5 cm
Adequate renal, hepatic function
Adequate hematologic parameters at screening
Exclusion Criteria:
Subjects who relapsed or progressed on BCL-2 inhibitor
Relapsed within 2 years of discontinuation of prior PI3K inhibitor (PI3Ki) therapy or disease progression on PI3Ki therapy
History or currently active HBV, HCV; any uncontrolled active infection, HIV infection; HIV-related lymphoma
History of Richter's transformation or prolymphocytic leukemia
Known allergies to both xanthine oxidase inhibitors and rasburicase, or any excipients of the drug products
Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure
Pregnant women
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There are 4 Locations for this study
Boston Massachusetts, 02215, United States
Stony Brook New York, 11794, United States
Oklahoma City Oklahoma, 73104, United States
Spokane Washington, 99208, United States
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