Spots Global Cancer Trial Database for Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas
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Trial Identification
Brief Title: Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas
Official Title: A Phase 2 Study to Assess the Efficacy and Safety of Idelalisib in Subjects With Indolent B-Cell Non-Hodgkin Lymphomas Refractory to Rituximab and Alkylating Agents
Study ID: NCT01282424
Interventions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Saint 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 Benite, , France
Centre Henri Bequerel, Rouen, , France
CHU Bretonneau - Centre Kaplan, Tours, , France
Charité Campus Virchow Klinikum, Berlin, , Germany
Universitätsklinikum Essen, Essen, , Germany
Klinikum der Universität München-Großhadern, München, , Germany
Universitatsklinikum Ulm, Ulm, , Germany
Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi, Bologna, , Italy
A.O.U. San Martino, Genova, , Italy
Fondazione Centro San Raffaele del Monte Tabor, Milano, , Italy
Università "Sapienza", Rome, , Italy
Małopolskie Centrum Medyczne, Kraków, , Poland
Centrum Onkologii w Warszawie, Warsaw, , Poland
St James's Institute of Oncology, Leeds, , United Kingdom
St Bartholemews Hospital, London, , United Kingdom
Sarah Cannon Institute, London, , United Kingdom
The Christie Hospital, Manchester, , United Kingdom
Southampton General Hospital, Southampton, , United Kingdom
Contact Details
Name: Gilead Study Director
Affiliation: Gilead Sciences
Role: STUDY_DIRECTOR
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