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 |
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).
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
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
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MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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9280 W. Sunset Road
Suite 100
Las Vegas, Nevada 89148
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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UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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Sarah Cannon Cancer Center People who live with cancer
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Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
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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Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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