CRC 13050: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination with Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas
- Type of Study
- Cancer (Oncology) - Lymphoma
- Swedish Cancer Institute
- Short Description
Purpose: The purpose of this study is to evaluate the effect of idelalisib (GS-1101) on the onset, magnitude, and duration of tumor control.
- Open to Enrollment
- Principal Investigator
- Michael Milder, M.D.
- Eligibility Notes
Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following
- Follicular lymphoma (FL) Grade 1, 2, or 3a
- Small lymphocytic lymphoma (SLL)
- Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)
- Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)
- No known histological transformation to an aggressive lymphoma
- No 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.
- No prior treatment with bendamustine that was not effective.
- No prior treatment with rituximab that was not effective
- Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following
- More Info Link
- Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
- (206) 215-3086