A Phase 2 Single-Arm, Open-Label Study to Assess the Safety and Efficacy of Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia - The CORAL Study

ME-401-008

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

2022-11-22

2023-03-15

2023-03-15

Withdrawn

Early phase I

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'This open label study is composed of 2 cohorts:\n\nA safety run-in Cohort A followed by Cohort B.\n\nBoth cohorts will follow the same dosing schedule and subjects will receive Zandelisib, however in Cohort A, VEN will be administered at a different dose then Cohort B.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2023-03-16