Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Indolent Non-Hodgkin's Lymphomas
In brief
The primary objective of this study is to evaluate the addition of idelalisib to bendamustine/rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).
Key facts
- Study ID
- NCT01732926
- Run by
- Gilead Sciences
- People needed
- 475
- Starts
- 2013-01-02
- Expected to finish
- 2016-05-17
- Last updated by the study team
- 2018-11-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Ironwood Cancer and Research Center — Chandler, Arizona, United States
- Comprehensive Blood and Cancer Center (Bakersfield) — Bakersfield, California, United States
- Saint Jude Heritage Healthcare (TORI) — Fullerton, California, United States
- Pacific Shores Medical Group — Long Beach, California, United States
- Cancer Care Associates — Redondo Beach, California, United States
- San Luis Obispo Oncology and Hematology — San Luis Obispo, California, United States
- Cancer Center of Santa Barbara — Santa Barbara, California, United States
- Central Coast Medical Oncology Group — Santa Maria, California, United States
- St Joseph Heritage Healthcare System — Santa Rosa, California, United States
- Kaiser Permanente Vallejo Medical Center — Vallejo, California, United States
- Sylvester Comprehensive Cancer Center/UMHC — Deerfield Beach, Florida, United States
- Cancer Specialists of North Florida — Jacksonville, Florida, United States
- Northwest Georgia Oncology Centers, PC — Marietta, Georgia, United States
- Rush University Medical Center — Chicago, Illinois, United States
- Joliet Oncology Hematology Associates Ltd. — Joliet, Illinois, United States
- Cancer Center of Kansas — Wichita, Kansas, United States
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
- North Shore Hematology/Oncology Associates — East Setauket, New York, United States
- Weill Cornell Medical College — New York, New York, United States
- Signal Point Clinical Research Center, LLC — Middletown, Ohio, United States
- Hollings Cancer Center — Charleston, South Carolina, United States
- Bon Secours Saint Francis Hospital — Greenville, South Carolina, United States
- Texas Oncology, P.A. — Bedford, Texas, United States
- Charles A. Sammons Cancer Center — Dallas, Texas, United States
- Clearview Cancer Institute — Huntsville, Alabama, United States
Full record on ClinicalTrials.gov
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