Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With CLL

Withdrawn before enrolling · Phase 2

Conditions studied: CLL

In brief

A Phase 2 study of Zandelisib with Venetoclax (VEN) and Rituximab (R) in subjects with Relapsed/Refractory CLL.

Key facts

Study ID

NCT05209308

Run by

MEI Pharma, Inc.

People needed

0

Starts

2022-11-22

Expected to finish

2023-03-15

Last updated by the study team

2023-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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