Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas



Status:Terminated
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/18/2018
Start Date:January 2, 2013
End Date:May 17, 2016

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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).


Key Inclusion Criteria:

- Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited
to the following

1. Follicular lymphoma (FL) Grade 1, 2, or 3a

2. Small lymphocytic lymphoma (SLL)

3. Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)

4. Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)

Key Exclusion Criteria:

- History of lymphoid malignancy other than those allowed per inclusion criteria.

- Ongoing drug-induced liver injury, active hepatitis C, active hepatitis B, alcoholic
liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic
obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.

- Prior treatment with bendamustine that was not effective.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
34
sites
3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
(210) 916-4141
Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
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Bedford, Texas 76022
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Chandler, Arizona 85224
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Charleston, South Carolina 29425
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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Dallas, Texas 75246
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Deerfield Beach, Florida 33442
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Denton, Texas 76210
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East Setauket, New York 11733
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Fullerton, California 92835
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2845 Greenbrier Rd
Green Bay, Wisconsin 54311
(920) 288-8000
Aurora BayCare Medical Center Aurora BayCare Medical Center is a 167-bed, full-service hospital serving the...
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Greenville, South Carolina 29601
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Harlingen, Texas 78550
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Huntsville, Alabama 35805
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Jacksonville, Florida 32256
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Joliet, IL
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Long Beach, California 90813
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Marietta, Georgia 30060
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Middletown, OH
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New Brunswick, New Jersey 08903
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New York, New York 10021
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Randwick, New South Wales 2031
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Redondo Beach, California 90277
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San Luis Obispo, California 93401
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Santa Barbara, California 93105
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Santa Maria, California 93454
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Santa Rosa, California 95403
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Tacoma, Washington 98405
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Vallejo, California 94589
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Weslaco, Texas 78596
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818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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