Efficacy and Safety of Idelalisib (GS-1101) in Combination With 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 16, 2013
End Date:May 18, 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 Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas

The primary objective of this study is to evaluate the effect of the addition of idelalisib
to 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) with absolute lymphocyte count < 5 x 10^9/L at
the time of diagnosis

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.

- Received previous treatment with rituximab that was not effective.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
33
sites
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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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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Chattanooga, Tennessee 37404
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2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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Duarte, California 91010
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Fort Myers, FL
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Fullerton, California
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Huntsville, Alabama 35805
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Long Beach, California 90813
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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Middletown, Connecticut 06457
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230 25th Ave N
Nashville, Tennessee 37203
(615) 329-7274
Sarah Cannon Cancer Center People who live with cancer
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New York, New York 10021
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Philadelphia, Pennsylvania 19104
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Redondo Beach, California 90277
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Santa Barbara, California 93105
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Santa Maria, California 93454
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Seattle, Washington 98101
(888) 862-2737
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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Tacoma, Washington 98405
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Tampa, Florida 33612
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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Watertown, South Dakota 57201
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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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Winchester, Virginia 22601
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