Extension Study of Idelalisib in Participants With Chronic Lymphocytic Leukemia (CLL) Who Participated in GS-US-312-0116 (NCT01539512)

Not Recruiting

Trial ID: NCT01539291


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
Caroline Berube

Clinical Associate Professor, Medicine - Hematology


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.


drug: Idelalisib

drug: Idelalisib

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office

New Trial Alerts

Receive email alerts when trials open to patients.