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Extension Study of Idelalisib in Participants With Chronic Lymphocytic Leukemia (CLL) Who Participated in GS-US-312-0116 (NCT01539512)
Not Recruiting
Trial ID: NCT01539291
Purpose
The primary objective of this extension study (GS-US-312-0117) that is a companion study to
Study GS-US-312-0116 (NCT01539512), is to evaluate the effect of idelalisib on the onset,
magnitude, and duration of tumor control. Randomization was done in study GS-US-312-0116, and
carried forward to study GS-US-312-117.
Official Title
A Phase 3, Double-Blind Extension Study Evaluating the Efficacy and Safety of Two Different Dose Levels of Single-Agent Idelalisib (GS-1101) for Previously Treated Chronic Lymphocytic Leukemia A Companion Trial to Study GS-US-312-0116: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia
Stanford Investigator(s)
Jason Gotlib
Professor of Medicine (Hematology)
Caroline Berube
Clinical Associate Professor, Medicine - Hematology
Eligibility
Key Inclusion Criteria:
- Individuals in the primary Phase 3 study (Study GS-US-312-0116) who are compliant
- Tolerating primary study therapy
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention(s):
drug: Idelalisib
drug: Idelalisib
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061