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

Conditions

• Ann Arbor Stage II Mantle Cell Lymphoma
• Ann Arbor Stage III Mantle Cell Lymphoma
• Ann Arbor Stage IV Mantle Cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Cisplatin — DRUG
  Given IV
• Computed Tomography — PROCEDURE
  Undergo CT scan
• Cyclophosphamide — DRUG
  Given IV
• Cytarabine — DRUG
  Given IV
• Dexamethasone — DRUG
  Given PO
• Doxorubicin — DRUG
  Given IV
• Glofitamab — BIOLOGICAL
  Given IV
• Positron Emission Tomography — PROCEDURE
  Undergo PET scan
• Prednisone — DRUG
  Given PO
• Rituximab — BIOLOGICAL
  Given IV
• Vincristine — DRUG
  Given IV

Study Details

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.

Key Dates

Start date

Aug 20, 2026

Status verified

Mar 2026

Primary completion

Sep 1, 2027

Completion

Sep 1, 2027

Study Design

Enrollment

16 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (glofitamab with R-CHOP/R-DHAP)
  INDUCTION: CYCLES: 1, 3 and 5: Patients receive rituximab IV, cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1, as well as prednisone PO on days 1-5. Starting with cycle 3, patients also receive glofitamab IV, over 2-8 hours, on day 8 of each cycle. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. CYCLES 2, 4 and 6: Patients receive rituximab IV, and cisplatin IV over 24 hours on day 1, as well as cytarabine IV on day 2 and dexamethasone PO on days 1-4. Patients also receive glofitamab IV, over 2-8 hours, on days 8 and 15 of cycle 2 and on day 8 of subsequent cycles. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive glofitamab IV on day 1 of each cycle. Cycles repeat every 21 days for a total of 24 months of treatment, in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of adverse events (AEs) [ Time Frame: Up to 5 years ]