NCT05783596

Glofit and Obin in Follicular Lymphoma and Marginal Zone Lymphoma

A Phase 2 Study of Glofitamab and Obinutuzumab for First-line Treatment of Follicular Lymphoma and Marginal Zone Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Reid Merryman, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Follicular Lymphoma
• Marginal Zone Lymphoma
• Indolent Non-hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Obinutuzumab	Humanized glycoengineered type II anti-CD20 monoclonal antibody, via IV infusion.
DRUG	Glofitamab	T-cell bispecific humanized monoclonal antibody, via IV infusion.

Timeline

• Start date: 2023-07-18
• Primary completion: 2026-08-01
• Completion: 2029-08-01
• First posted: 2023-03-24
• Last updated: 2026-03-16

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study