Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Adults With Previously Untreated Chronic Lymphocytic Leukemia
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Chronic Lymphocytic Leukemia
In brief
The primary objective of this study is to evaluate the progression-free survival in participants with previously untreated chronic lymphocytic leukemia (CLL) who would otherwise be suitable for bendamustine and rituximab treatment as standard of care. An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (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
- NCT01980888
- Run by
- Gilead Sciences
- People needed
- 311
- Starts
- 2014-02-05
- Expected to finish
- 2016-06-16
- Last updated by the study team
- 2018-11-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UCSD Moores Cancer Center — La Jolla, California, United States
- Central Coast Medical Oncology — Santa Maria, California, United States
- Georgetown University — Washington D.C., District of Columbia, United States
- Memorial Healthcare System — Hollywood, Florida, United States
- Cancer Specialists of North Florida — Jacksonville, Florida, United States
- Florida Cancer Specialists-South — Sarasota, Florida, United States
- Franciscan Physician Network Oncology & Hematology — Indianapolis, Indiana, United States
- Siouxland Hematology-Oncology Associates, LLP — Sioux City, Iowa, United States
- Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
- Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
- Hematology /Oncology Associates of Northern New Jersey — Morristown, New Jersey, United States
- Columbia University Medical Center — New York, New York, United States
- University of Rochester — Rochester, New York, United States
- Gabrail Cancer Center Research — Canton, Ohio, United States
- Sarah Cannon Research Institute — Cincinnati, Ohio, United States
- Signal Point Clinical Research Center — Middletown, Ohio, United States
- Saint Francis Hospital — Greenville, South Carolina, United States
- Sarah Cannon Research Institute — Nashville, Tennessee, United States
- Texas Oncology-Austin Midtown — Austin, Texas, United States
- Texas Oncology-Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States
- Utah Cancer Specialists — Salt Lake City, Utah, United States
- Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
- St Vincent's Hospital, Sydney — Darlinghurst, New South Wales, Australia
- Jarrett Street Specialist Centre — North Gosford, New South Wales, Australia
- St. Jude Heritage Healthcare Virginia K. Crosson Cancer Center — Fullerton, California, 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.