Diffuse Large B-Cell Lymphoma Clinical Trial
Official title:
Immunostart: Prephase Tafasitamab, Retifanlimab, and Rituximab (TRR), Followed by TRR-CHOP, for Previously Untreated Diffuse Large B-Cell Lymphoma
This phase I/II trial tests the safety of tafasitamab, retifanlimab, and rituximab (TRR) as a prephase treatment and in combination with standard chemotherapy consisting off cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with untreated diffuse large B-cell lymphoma. Tafasitamab, retifanlimab, and rituximab are monoclonal antibodies. Tafasitamab binds to a protein called CD19, which is found on B-cells (a type of white blood cell) and some types of cancer cells. Rituximab binds to a protein called CD20, which is also found on B-cells and some cancer cells. These monoclonal antibodies may help the immune system kill cancer cells. Immunotherapy with other monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as CHOP, 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. Giving TRR in combination with CHOP may kill more cancer cells.
OUTLINE: PREPHASE THERAPY: Patients receive tafasitamab intravenously (IV) over 30 minutes on days 1, 8, and 15 of each cycle, rituximab and hyaluronidase human subcutaneously (SC) on day 1 of each cycle, and retifanlimab IV over 30 minutes on day 8 of each cycle. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. COMBINATION THERAPY: After completion of prephase therapy or if patients progress during prephase therapy, patients receive tafasitamab IV over 30 minutes, retifanlimab IV over 30 minutes, rituximab and hyaluronidase human SC, cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 of each cycle. Patients also receive prednisone orally (PO) on days 1-5 of each cycle. Treatment repeats every 21 days for 4-6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo optional bone marrow biopsy and aspiration and multi-gated acquisition (MUGA) scan at screening, and fludeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) scan and collection of blood and tissue samples throughout the trial. After completion of study treatment, patients are followed up at 4-6 weeks, 12 weeks and then per routine care for up to 5 years. ;
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