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.
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3550 Jerome Avenue
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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
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Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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3551 Roger Brooke Dr
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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
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Duarte, California 91010
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Huntsville, Alabama 35805
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9280 W. Sunset Road Suite 100
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Long Beach, California 90813
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757 Westwood Plaza
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Middletown, Connecticut 06457
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230 25th Ave N
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Sarah Cannon Cancer Center People who live with cancer
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New York, New York 10021
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Philadelphia, Pennsylvania 19104
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3800 Reservoir Rd NW
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Watertown, South Dakota 57201
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818 N. Emporia, #403
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