Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma

This phase I trial tests the safety, side effects and best dose of glofitamab given with alternating cycles of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)/ rituximab, dexamethasone, cytarabine, and cisplatin (R-DHAP) for the treatment of mantle cell lymphoma. Glofitamab is a monoclonal antibody 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). Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone and dexamethasone are in a class of medications called corticosteroids. They are used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Chemotherapy drugs, such as cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Giving glofitamab may be safe, tolerable and/or effective in treating patients with mantle cell lymphoma.

NCT Number	NCT07444710
Lead Sponsor	National Cancer Institute (NCI)
Conditions	Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma, Ann Arbor Stage IV Mantle Cell Lymphoma
Enrollment	16 participants
Start Date	2026-08-20
Primary Completion	2027-09-01 (estimated)
Study Completion	2027-09-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-08