©2024 Stanford Medicine
Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela )
Not Recruiting
Trial ID: NCT01569295
Purpose
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)
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia
Eligibility
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.
Intervention(s):
drug: Idelalisib
drug: Rituximab
drug: Bendamustine
drug: Placebo to match idelalisib
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061