Trial Search Results
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).
Stanford is currently not accepting patients for this trial.
- Drug: Idelalisib
- Drug: Rituximab
- Drug: Bendamustine
- Drug: Placebo
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.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study