5401W-13: Gilead NHL

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
Location
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.

Status
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
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.
Phone
(206) 215-3086
Email
CancerResearch@swedish.org