Discontinuation of zandelisib development

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

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.

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