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Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
Trial ID: NCT01732913
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).
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
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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