RecruitingPhase 1Phase 2NCT05455697

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


Sponsor

University of Washington

Enrollment

35 participants

Start Date

Jan 26, 2023

Study Type

INTERVENTIONAL

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests adding two immunotherapy drugs — tafasitamab (targets CD19 on cancer cells) and retifanlimab (an immune checkpoint blocker) — to the standard rituximab-plus-chemotherapy (R-CHOP) regimen for newly diagnosed diffuse large B-cell lymphoma (DLBCL), an aggressive blood cancer. **You may be eligible if...** - You are 18 or older with a new diagnosis of diffuse large B-cell lymphoma (DLBCL) or grade 3B follicular lymphoma - You have not received any prior lymphoma treatment - Your cancer is measurable on CT or PET scan - Your general health is adequate for chemotherapy (ECOG performance status 0–2) **You may NOT be eligible if...** - You have received prior chemotherapy or radiation for lymphoma - You have active autoimmune disease that could be worsened by immunotherapy - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding - You have active uncontrolled infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

DRUGCyclophosphamide

Given IV

DRUGDoxorubicin

Given IV

DRUGPrednisone

Given PO

BIOLOGICALRetifanlimab

Given IV

BIOLOGICALRituximab and Hyaluronidase Human

Given SC

BIOLOGICALTafasitamab

Given IV

DRUGVincristine

Given vincristine

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDUREMultigated Acquisition Scan

Undergo MUGA

OTHERFludeoxyglucose F-18

Undergo FDG-PET/CT

PROCEDUREPositron Emission Tomography

Undergo FDG-PET

PROCEDUREComputed Tomography

Undergo FDG-CT

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

DRUGPolatuzumab Vedotin

Given IV


Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

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NCT05455697