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.

Lead Sponsor:

Gilead Sciences

Stanford Investigator(s):

Intervention(s):

  • Drug: Idelalisib
  • Drug: Rituximab
  • Drug: Bendamustine
  • Drug: Placebo

Phase:

Phase 3

Eligibility


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

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting