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

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

• University of Washington

  lead OTHER

Principal Investigators

• Stephen D. Smith · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-26

Primary Completion

2027-01-05

Completion

2027-07-06

FDA Drug

Yes

Countries

• United States

Study Locations