A Phase 2, Single-Arm, Open-Label Study Evaluating the Efficacy and Safety of Single Agent GS 1101 (CAL 101) as Therapy for Previously Treated Chronic Lymphocytic Leukemia
This is a Phase 2, multicenter, single-arm, controlled, clinical trial evaluating the
efficacy and safety of the phosphatidylinositol 3-kinase delta (PI3K-delta) inhibitor
GS-1101 (CAL-101) as therapy for previously treated chronic lymphocytic leukemia.
This clinical trial (Study GS-US-312-0120) is a single-arm in which compliant subjects from
GS US-312-0119 -Arm B who experience progression of CLL while receiving single-agent
ofatumumab therapy are potentially eligible to receive single-agent, open-label GS 1101
therapy.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
18 mon
No
Langdon Miller, MD
Study Director
Gilead Sciences
United States: Food and Drug Administration
GS-US-312-0120
NCT01659047
August 2012
December 2015
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