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OncoMatch/Clinical Trials/NCT05455697

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

Is NCT05455697 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for diffuse large b-cell lymphoma.

Phase 1/2RecruitingUniversity of WashingtonNCT05455697Data as of May 2026

Treatment: Cyclophosphamide · Doxorubicin · Prednisone · Retifanlimab · Rituximab and Hyaluronidase Human · Tafasitamab · Vincristine · Polatuzumab VedotinThis 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.

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Extracted eligibility criteria

Cancer type

Diffuse Large B-Cell Lymphoma

Non-Hodgkin Lymphoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: anti-PD-1 therapy

prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)

Lab requirements

Blood counts

Absolute neutrophil count (ANC) >= 1,000/mcL except in case of marrow infiltration by lymphoma; Platelets >= 75,000/mcL except in cases of marrow infiltration by lymphoma

Kidney function

Serum creatinine clearance (CrCl) >= 30 mL/minute either measured or calculated

Liver function

Serum total bilirubin <= 1.5 x ULN unless secondary to Gilbert's syndrome or documented liver involvement by lymphoma (<= 5 x ULN if so); AST and ALT <= 2.5 x ULN OR <= 5 x ULN for subjects with liver metastases

Cardiac function

Left ventricular ejection fraction of >= 45%, assessed by echocardiography or cardiac multi-gated acquisition (MUGA) scan

ANC >= 1,000/mcL except in case of marrow infiltration by lymphoma; Platelets >= 75,000/mcL except in cases of marrow infiltration by lymphoma; Serum creatinine clearance (CrCl) >= 30 mL/minute; Serum total bilirubin <= 1.5 x ULN unless secondary to Gilbert's syndrome or documented liver involvement by lymphoma (<= 5 x ULN if so); AST and ALT <= 2.5 x ULN OR <= 5 x ULN for subjects with liver metastases; Left ventricular ejection fraction of >= 45%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Fred Hutch/University of Washington Cancer Consortium · Seattle, Washington

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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