NCT05455697

Tafasitamab, Retifanlimab, and Rituximab in Combination With Standard Therapy for the Treatment of Diffuse Large B-cell Lymphoma

Immunostart: Prephase Tafasitamab, Retifanlimab, and Rituximab (TRR), Followed by TRR With Standard Therapy for Previously Untreated Diffuse Large B-Cell Lymphoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial tests the safety of tafasitamab, retifanlimab, and rituximab (TRR) as a prephase treatment and in combination with standard therapy consisting off cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or polatuzumab vedotin, cyclophosphamide, doxorubicin, and prednisone (PolaCHP) 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 and PolaCHP, 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 or PolaCHP may kill more cancer cells.

Detailed description

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 with an international prognostic index (IPI) score of 2-5 may receive polatuzumab vedotin IV in place of vincristine at investigator discretion. 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.

Conditions

• Diffuse Large B-Cell Lymphoma
• Grade 3b Follicular Lymphoma
• High Grade B-Cell Lymphoma

Interventions

Type	Name	Description
PROCEDURE	Bone Marrow Biopsy	Undergo bone marrow biopsy
DRUG	Cyclophosphamide	Given IV
DRUG	Doxorubicin	Given IV
DRUG	Prednisone	Given PO
BIOLOGICAL	Retifanlimab	Given IV
BIOLOGICAL	Rituximab and Hyaluronidase Human	Given SC
BIOLOGICAL	Tafasitamab	Given IV
DRUG	Vincristine	Given vincristine
PROCEDURE	Bone Marrow Aspiration	Undergo bone marrow aspiration
PROCEDURE	Multigated Acquisition Scan	Undergo MUGA
OTHER	Fludeoxyglucose F-18	Undergo FDG-PET/CT
PROCEDURE	Positron Emission Tomography	Undergo FDG-PET
PROCEDURE	Computed Tomography	Undergo FDG-CT
PROCEDURE	Biospecimen Collection	Undergo collection of blood samples
DRUG	Polatuzumab Vedotin	Given IV

Timeline

• Start date: 2023-01-26
• Primary completion: 2027-01-05
• Completion: 2027-07-06
• First posted: 2022-07-13
• Last updated: 2025-12-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study