This phase I trial tests the safety and side effects of external beam radiation therapy followed by treatment with epcoritamab or glofitamab for the treatment of diffuse large b-cell lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). External beam radiation therapy is a type of radiation therapy in which high-energy beams are delivered to the tumor from outside of the body. Epcoritamab and glofitamab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving external beam radiation therapy followed by treatment with epcoritamab or glofitamab may be safe and tolerable in treating patients with relapsed or refractory diffuse large b-cell lymphoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07528352.
Locations matching your search criteria
United States
Utah
Salt Lake City
Huntsman Cancer Institute/University of UtahStatus: Approved
Contact: Allison Bock
Phone: 801-585-0255
PRIMARY OBJECTIVE:
I. To assess the safety and tolerability of radiation therapy followed by bispecific antibody (BsAb) therapy (epcoritamab or glofitamab) in patients with relapsed/refractory (R/R) diffuse large b-cell lymphoma (DLBCL).
SECONDARY OBJECTIVES:
I. To assess other adverse events of radiation therapy followed by bispecific antibody (BsAb) therapy (epcoritamab or glofitamab) in patients with R/R DLBCL.
II. To assess the complete response rate (CRR) in the study population.
III. To assess the objective response rate (ORR) in the study population.
EXPLORATORY OBJECTIVES:
I. To assess overall survival in this study population.
II. To assess the duration of response (DoR) of the study population.
III. To assess progression-free survival (PFS).
IV. To evaluate change in T-Cell function, T and myeloid cell phenotype, cytokine secretion, and total metabolic tumor volume.
OUTLINE:
Patients undergo external beam radiation therapy (EBRT) for 5 treatments, over 5 days if feasible. Starting within 9 days patients receive physician’s choice of standard of care (SOC) epcoritamab or glofitamab. Patients receiving epcoritamab receive it subcutaneously (SC) on day 1, 8, 15 and 22 of cycles 1-3 and days 1 and 15 of cycles 4-6. Cycles repeat every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients receiving glofitamab intravenously (IV), over 2-4 hours, on days 1, 8 and 15 of cycle 1 and on day 1 of subsequent cycles. Cycles repeat every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Following completion of 6 cycles of therapy, patients may continue to receive epcoritamab or glofitamab per SOC. Patients undergo positron emission tomography (PET) scan, computed tomography (CT) scan and blood sample collection throughout the study and optionally undergo tumor biopsy and/or bone marrow biopsy and/or aspiration throughout the study.
After completion of study treatment, patients are followed up at 28 days and every 12 weeks for 1 year.
Lead OrganizationHuntsman Cancer Institute/University of Utah
Principal InvestigatorAllison Bock
