GS-US-313-0125: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination with Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas

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GS-US-313-0125: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination with Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas

Primary Objective:To evaluate the effect of the addition of GS-1101 to B/R on PFS in subjects with previously treated iNHL

Secondary Objectives:
To evaluate the effect of the addition of GS-1101 to B/R on the onset, magnitude, and duration of tumor control
-To assess the effect of the addition of GS-1101 to B/R on measures of subject well-being, including OS, HRQL, and performance status
-To assess the effects of the addition of GS-1101 to B/R on disease-associated biomarkers
-To characterize exposure to study treatment as determined by treatment administration with each of the therapeutic agents and evaluation of GS-1101 plasma concentrations over time
-To describe the safety profile observed with the addition of GS-1101 to B/R
-To estimate health resource utilization associated with the addition of GS-1101 to B/R

Protocol Number011301
Principal InvestigatorKevin David
PhasePhase III
ScopeNational
Applicable Disease SitesNon-Hodgkin's Lymphoma
Therapies InvolvedChemotherapy multiple agents systemic
Drugs InvolvedPLACEBO
RITUXIMAB
GS-1101
BENDAMUSTINE
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.