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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
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).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Clearview Cancer Institute
Huntsville, Alabama, United States
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
Start Date
January 2, 2013
Primary Completion Date
May 17, 2016
Completion Date
May 17, 2016
Last Updated
November 16, 2018
475
ACTUAL participants
Idelalisib
DRUG
Rituximab
DRUG
Bendamustine
DRUG
Placebo
DRUG
Lead Sponsor
Gilead Sciences
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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