Status:
WITHDRAWN
Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With CLL
Lead Sponsor:
MEI Pharma, Inc.
Collaborating Sponsors:
Kyowa Kirin, Inc.
Conditions:
CLL
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A Phase 2 study of Zandelisib with Venetoclax (VEN) and Rituximab (R) in subjects with Relapsed/Refractory CLL.
Detailed 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 h...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05209308
Start Date
November 22 2022
End Date
March 15 2023
Last Update
March 16 2023
Active Locations (4)
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1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
2
Stony Brook University
Stony Brook, New York, United States, 11794
3
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
4
Medical Oncology Associates, PS (dba Summit Cancer Centers)
Spokane, Washington, United States, 99208