Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas
Completed · Phase 2
Conditions studied: Follicular Lymphoma, Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma, Marginal Zone Lymphoma
In brief
The primary objective will be to assess the overall response rate and to evaluate the efficacy and safety of idelalisib (IDELA; GS-1101) in participants with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to alkylating-agent-containing chemotherapy. Eligible participants will initiate oral therapy with idelalisib at a starting dose of 150 mg taken twice per day. Treatment with idelalisib can continue in compliant participants as long as the study is still ongoing and the participants appear to be benefiting from treatment with acceptable safety.
Key facts
- Study ID
- NCT01282424
- Run by
- Gilead Sciences
- People needed
- 125
- Starts
- 2011-03-18
- Expected to finish
- 2018-05-16
- Last updated by the study team
- 2019-07-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- St. Jude Medical Center — Fullerton, California, United States
- Pacific Shores Medical Group — Long Beach, California, United States
- UCLA — Los Angeles, California, United States
- Central Coast Medical Oncology — Santa Maria, California, United States
- Stanford Cancer Center — Stanford, California, United States
- Collaborative Research Group, LLC — Boynton Beach, Florida, United States
- Winship Cancer Institute — Atlanta, Georgia, United States
- Northwestern University Robert H. Lurie Comprehensive Cancer Center — Chicago, Illinois, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- John Theurer Cancer Center Hackensack University Medical Center — Hackensack, New Jersey, United States
- University of Medicine and Dentistry of NJ — New Brunswick, New Jersey, United States
- Weill Cornell -New York Presbyterian Hospital — New York, New York, United States
- Montefiore Medical Center — New York, New York, United States
- The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- South Carolina Oncology Associates — Columbia, South Carolina, United States
- Chattanooga Hem/Oncology Ass (SCRI) — Chattanooga, Tennessee, United States
- Sarah Cannon Research Institute — Nashville, Tennessee, United States
- Charles A. Sammons Cancer Center — Dallas, Texas, United States
- University of Virginia Medical Center — Charlottesville, Virginia, United States
- Seattle Cancer Care Alliance — Seattle, Washington, United States
- University of Wisconsin — Madison, Wisconsin, United States
- CHU Morvan — Brest, France
- Centre Hospitalier de Lyon Sud — Pierre-Bénite, France
- Centre Henri Bequerel — Rouen, France
Full record on ClinicalTrials.gov
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