Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela )

• Status: Completed
• Trial end date: 2019-06-10
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the effect of the addition of idelalisib (formerly GS-1101) to bendamustine + rituximab (BR) on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Bendamustine Hydrochloride; Idelalisib; Rituximab

Criteria

Key Inclusion Criteria:

• Previously treated recurrent CLL

• Measurable lymphadenopathy

• Requires therapy for CLL

• Has experienced CLL progression < 36 months since the completion of the last prior therapy

Key Exclusion Criteria:

• Recent history of a major non-CLL malignancy

• Evidence of an ongoing infection

• CLL refractory to bendamustine

• Concurrent participation in another therapeutic clinical trial

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.