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

A Phase 2 Study to Assess the Safety and Efficacy of TGR-1202 (Umbralisib) in Patients With Chronic Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK or PI3K-Delta Inhibitor Therapy

The main objective of this study is to determine the progression free survival of umbralisib in participants who were intolerant to prior BTK (Bruton Tyrosine Kinase) inhibitors (ibrutinib, ACP-196, other) or prior PI3K-delta inhibitors (idelalisib, duvelisib, other).

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