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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
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

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