Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
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).
Dana-Farber Cancer Institute, Brigham and Women's Hospital
Caron Jacobson. M.D,
Dana Farber Cancer Institute
Dana-Farber Cancer Institute:
- 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)
- 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.