Efficacy and Safety of Idelalisib (GS-1101) in Combination With 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 effect of the addition of idelalisib to 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
- NCT01732913
- Run by
- Gilead Sciences
- People needed
- 295
- Starts
- 2013-01-16
- Expected to finish
- 2016-05-18
- 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
- City of Hope Cancer Center — Duarte, California, United States
- Saint Jude Heritage Healthcare — Fullerton, California, United States
- Pacific Shores Medical Group — Long Beach, California, United States
- UCLA Medical Center — Los Angeles, California, United States
- Cancer Care Associates — Redondo Beach, California, United States
- Cancer Center of Santa Barbara — Santa Barbara, California, United States
- Central Coast Medical Oncology Group — Santa Maria, California, United States
- Middlesex Hospital Cancer Center — Middletown, Connecticut, United States
- Georgetown University Medical Center — Washington D.C., District of Columbia, United States
- Florida Cancer Specialists and Research Institute — Fort Myers, Florida, United States
- Moffitt Cancer Center — Tampa, Florida, United States
- Cancer Center of Kansas — Wichita, Kansas, United States
- Wayne State University — Detroit, Michigan, United States
- Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
- Weill Cornell Medical College — New York, New York, United States
- Montefiore Medical Center — The Bronx, New York, United States
- MetroHealth Medical Center — Cleveland, Ohio, United States
- Signal Point Clinical Research Center, LLC — Middletown, Ohio, United States
- Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States
- Prairie Lakes Healthcare System — Watertown, South Dakota, United States
- Tennessee Oncology, PLLC — Chattanooga, Tennessee, United States
- Sarah Cannon Cancer Center — Nashville, Tennessee, United States
- Clearview Cancer Institute — Huntsville, Alabama, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.