Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With CLL

• Status: Not yet recruiting
• Trial end date: 2026-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MEI Pharma, Inc.
• Collaborator: Kyowa Kirin
• Treatments: Rituximab; Venetoclax

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