A Phase 2 Study of Glofitamab and Obinutuzumab for first-line treatment of follicular lymphoma and marginal zone lymphoma

Contact:

NCT Number:

Protocol:

AAAV1648

Study Status:

Active/Enrolling

Population:

Adult

Phase:

II

The purpose of this study is to determine how effective and safe the combination of glofitamab and obinutuzumab is in treating patients with Follicular Lymphoma (FL) and Marginal Zone Lymphoma(MZL) who have not received other treatments for their lymphoma. The investigators hope that combining these two drugs can provide a more effective study treatment regimen for these diseases. In addition, pre-study treatment with obinutuzumab may reduce side effects associated with glofitamab study treatment, like cytokine release syndrome. The U.S. Food and Drug Administration (FDA) has not approved glofitamab as a study treatment for any disease. The U.S. Food and Drug Administration (FDA) has approved obinutuzumab in combination with chemotherapy for patients with follicular lymphoma. The U.S. Food and Drug Administration (FDA) has approved tocilizumab for study treatment of cytokine release syndrome (CRS) resulting from study treatment with chimeric antigen receptor (CAR) T cell therapy (a study treatment for certain types of lymphomas). Both glofitamab and obinutuzumab target a protein called CD20 that sits on the surface of your cancer cells. Both drugs are immunotherapies – they use your immune system to target and attack your cancer cells. Tocilizumab is an anti-inflammatory drug that can be used to treat potential side effects of study treatment if your immune system becomes overly activated.

Are you Eligible? (Inclusion Criteria)

  • Are you 18 years of age or older? Do you have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2? Are you able to provide a pre-treatment tumor sample?

Specialty Area(s)

Lymphoma, Non-Hodgkin's Lymphoma, Immunotherapy

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032