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.

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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.

View Eligibility Criteria

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

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

42

Study ID:

NCT05209308

Recruitment Status:

Recruiting

Sponsor:

MEI Pharma, Inc.

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There are 4 Locations for this study

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Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Stony Brook University
Stony Brook New York, 11794, United States
OU Health Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States
Medical Oncology Associates, PS (dba Summit Cancer Centers)
Spokane Washington, 99208, United States

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

42

Study ID:

NCT05209308

Recruitment Status:

Recruiting

Sponsor:


MEI Pharma, Inc.

How clear is this clinincal trial information?

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