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S1608: Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma

Clinical Trial Details

The purpose of this study is to compare any good and bad effects of using different drugs in combination with an antibody. An antibody is a protein that can recognize and attack foreign objects (antigens) in the body. Here, the antibody is obinutuzumab. It is looking for CD20, an antigen that is found on tumor cells. Two study drugs will be tested in this study: TGR-1202 and lenalidomide. Each of these study drugs may help the immune system fight cancer. During the study, you will receive either obinutuzumab plus TGR-1202, obinutuzumab plus lenalidomide, or obinutuzumab plus the usual treatment approach for your cancer. 

The addition of TGR-1202 or lenalidomide could shrink your cancer, but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the addition of a study drug should increase the chances of your cancer shrinking by about 45 percent compared to the usual approach.

The antibody (obinutuzumab) and the regular chemotherapy approach are FDA-approved for use in follicular lymphoma, but they aren’t usually used together. The immune system drug, TGR-1202, is not FDA-approved. The immune system drug lenalidomide is FDA-approved, but not for follicular lymphoma (your type of cancer). 

Another purpose of this study is to test PET/CT scans, which are a way to take pictures of your type of cancer. The researchers want to use PET/CT scans to help diagnose and monitor your cancer. PET/CT scans are a part of regular care for your type of cancer. All of the patients taking part in this study will have PET/CT scans sent to a central PET/CT reviewer. 

This study will also examine whether a set of gene mutations (called m7-FLIPI) can predict whether your lymphoma will respond better or worse to the study treatment. Mutations are permanent changes in your DNA. The researchers will look for the mutations on your tumor tissue and in tumor cells found in your blood. All of the patients taking part in this study will have blood and tissue submitted for these gene mutation tests. 

Key Eligibility: 

Open to adults with:

  • Follicular lymphoma (Grade I, II or IIIa) 
  • No involvement with large cell lymphoma 
  • No clinical evidence of central nervous system involvement by lymphoma 
  • Adequate bone marrow, renal and hepatic function    

Detailed eligibility will be reviewed when you contact the study team. 

Study contact by location

Upper East Side - Manhattan

Contact(s)

Amelyn Rodriguez, RN
(212) 746-1362
amr2017@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1710018701

ClinicalTrials.gov:

NCT03269669

Sponsor:

S1608

Status

Open to Enrollment

Age Group

Adult

Sponsor