Not Yet RecruitingPhase 1

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

16 participantsStarted 2026-08-20

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients must have histologically or cytologically confirmed previously untreated mantle cell lymphoma which is stage II bulky, stage III, or stage IV and fit for intensive chemotherapy. TP53 mutated patients are eligible * Patients must exhibit measurable disease by PET or CT imaging with at least one site of disease \> 1.5 cm in longest dimension or documented bone marrow involvement * Age ≥ 18 years to ≤ 75 years. Because no dosing or adverse event data are currently available on the use of glofitamab in combination with R-CHOP/R-DHAP in patients \< 18 years of age, children are excluded from this study * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%) * Absolute neutrophil count ≥ 1,000/mcL * Platelets ≥ 100,000/mcL * Total bilirubin ≤ 2 × institutional upper limit of normal (ULN) unless total bilirubin elevation is attributable to Gilbert's syndrome or lymphomatous infiltration of the liver in whom total bilirubin must be \< 3 times ULN * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 × institutional ULN * Creatinine clearance ≥ 30 ml/min * Left ventricular ejection fraction ≥ 45% by echocardiogram or Multiple-Gated Acquisition (MUGA) scan * International Normalized Ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN in the absence of therapeutic anticoagulation * Partial thromboplastin time (PTT) or…

What they're measuring

Incidence of adverse events (AEs)

Timeframe: Up to 5 years

Dose limiting toxicity (DLT)

Timeframe: From cycle 2, day 8 to cycle 5 day 1 (cycle length = 21 days)

Trial details

NCT IDNCT07444710

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2027-09-01