Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas

Status: Recruiting
Phase: Phase 3
Diagnosis: Non-Hodgkin's Lymphoma
NCT ID: NCT01732926 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-267


This study will evaluate the the addition of idelalisib to bendamustine/rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL).


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Caron Jacobson. M.D, Dana Farber Cancer Institute

Site-responsible Investigators:

Dana-Farber Cancer Institute: Kathleen McDermott, kmcdermott@partners.org

Eligibility Criteria

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) Exclusion Criteria: - Known histological transformation to an aggressive lymphoma - 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. - Prior treatment with rituximab that was not effective.
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