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Brief Title: Glofit and Obin in Follicular Lymphoma and Marginal Zone Lymphoma
Official Title: A Phase 2 Study of Glofitamab and Obinutuzumab for First-line Treatment of Follicular Lymphoma and Marginal Zone Lymphoma
Study ID: NCT05783596
Brief Summary: 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 names of the study drugs involved in this study are: * Glofitamab (a type of immunotherapy) * Obinutuzumab (a type of immunotherapy)
Detailed Description: This is an open-label, multicenter, phase II study to evaluate the efficacy and safety of obinutuzumab and glofitamab for patients with untreated follicular lymphoma (FL) or marginal zone lymphoma (MZL). Obinutuzumab and Glofitamab use the immune system to target and attack cancer cells. The research study procedures include screening for eligibility, study treatment visits, bone marrow biopsies, blood tests, Computerized Tomography (CT) scans, and Positron Emission Tomography (PET) scans. The U.S. Food and Drug Administration (FDA) has not approved glofitamab as a treatment for any disease. The U.S. FDA has approved obinutuzumab in combination with chemotherapy for patients with follicular lymphoma. Participants will receive study treatment for approximately 9 months and will be followed for 10 years. It is expected that about 45-50 people will take part in this research study. Genentech and Roche are supporting this research study by providing the study drugs, glofitamab and obinutuzumab, and funding for the study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Name: Reid Merryman, MD
Affiliation: Dana-Farber Cancer Institute
Role: PRINCIPAL_INVESTIGATOR