A Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas (Yosemite)
The purpose of this study is to evaluate the effect of idelalisib (GS-1101) on the onset, magnitude, and duration of tumor control
Indolent Non-Hodgkin's Lymphomas
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||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 Indolent Non-Hodgkin Lymphomas|
- Progression Free Survival [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]To evaluate the effect of the addition of idelalisib (GS-1101) to rituximab on progression-free survival in subjects with previously treated indolent non-Hodgkin lymphoma (iNHL)
- Overall Response Rate [ Time Frame: Assessed every 12 weeks until progression ] [ Designated as safety issue: No ]Overall Response Rate (ORR) is defined as the proportion of subjects who achieve a complete response or partial response (or very good partial response or minor response for patients with Waldenstrom's).
- Lymph Node Response [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]Lymph node response rate is defined as the proportion of subjects who achieve ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters of index lesions.
- Overall Survival [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]Overall survival is defined as the interval from randomization to death from any cause.
- Complete Response Rate [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]Complete response is defined as the proportion of patients who achieve a complete response.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||December 2021|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: Regimen A
Rituximab IV 375 mg/m2 weekly x 4, then every 8 weeks x 4; idelalisib (GS-1101) orally 150 mg BID until disease progression
Other Names:Drug: Rituximab
Active Comparator: Regimen B
Rituximab IV 375 mg/m2 weekly x 4, then every 8 weeks x 4; Placebo orally 150 mg BID until disease progression
|Drug: Rituximab Drug: Placebo|
This is a Phase 3, multicenter, 2-arm, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of the phosphatidylinositol 3-kinase delta (PI3K-delta) inhibitor idelalisib (GS-1101) in combination with Rituximab for previously treated indolent non-hodgkin lymphomas.
Eligible subjects will be randomized with a 2:1 allocation to Regimen A vs. Regimen B.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732913
|Contact: Meredith Cain||Meredith.email@example.com|
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|Study Director:||Henry Adewoye, MD||Gilead Sciences|