NCT05209308

Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With CLL

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: MEI Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• CLL

Interventions

Type	Name	Description
DRUG	Zandelisib	Zandelisib taken orally for 7 days of each 28 day cycle
DRUG	Rituximab	Rituximab IV for 6 cycles
DRUG	Venetoclax	Orally - Ramp up weeks 1-5

Timeline

• Start date: 2022-11-22
• Primary completion: 2023-03-15
• Completion: 2023-03-15
• First posted: 2022-01-26
• Last updated: 2023-03-16

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study