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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Progression Free Survival
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)
Every 12 weeks
No
Wayne Godfrey, MD
Study Director
Gilead Sciences
United States: Food and Drug Administration
GS-US-313-0124
NCT01732913
December 2012
June 2022
Name | Location |
---|---|
Middlesex Hospital Cancer Center | Middletown, Connecticut 06457 |
Pacific Shores Medical Group | Long Beach, California 90813 |
Pennsylvania Oncology Hematology Associates | Philadelphia, Pennsylvania 19107 |
Northwest Medical Specialties, PLLC | Tacoma, Washington 98405 |
Clearview Cancer Institute | Huntsville, Alabama 35805 |
Medical and Surgical Specialists, LLC | Galesburg, Illinois 61401 |
Cancer Center of Kansas | Wichita, Kansas 67214 |
Essex Oncology of North Jersey, PA | Belleville, New Jersey 07109 |
Center for Cancer and Blood Disorders, PC | Bethesda, Maryland 20817 |
Signal Point Clinical Research Center, LLC | Middletown, Ohio 45042 |
Illinois Cancer Specialists | Niles, Illinois 60714 |
Collaborative Research Group, LLC | Boynton Beach, Florida 33435 |
Providence Saint Joseph Medical Center-Disney Family Cancer Center | Burbank, California |
Cornerstone Hematology/Oncology | High Point, North Carolina 27262 |
Perelman Center for Advanced Medicine | Philadelphia, Pennsylvania 19104 |
Prairie Lakes Healthcare System | Watertown, South Dakota 57252 |