Evaluate the Efficacy and Safety of TGR-1202 in Patients With Chronic Lymphocytic Leukemia Who Are Intolerant to Prior Therapy

• Status: Completed
• Trial end date: 2021-06-10
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2, open-label, study of TGR-1202, a PI3K delta inhibitor, administered as a single agent in Chronic Lymphocytic Leukemia (CLL) patients who are intolerant to prior BTK inhibitors (ibrutinib, other) or prior PI3K delta inhibitors (idelalisib, other)

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

Details

• Lead Sponsor: TG Therapeutics, Inc.

Criteria

Inclusion Criteria:

• Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL)

• Discontinuation on prior BTK inhibitor or PI3K delta inhibitor due to adverse events within prior 9 months

• Presence of measurable disease

Exclusion Criteria:

• Progression on prior BTK or PI3K delta inhibitor

• Prior treatment with TGR-1202

• Richter's transformation or CLL transformation to aggressive lymphoma