Actively Recruiting
Tafasitamab, Retifanlimab, and Rituximab in Combination With Standard Therapy for the Treatment of Diffuse Large B-cell Lymphoma
Led by University of Washington · Updated on 2025-12-18
35
Participants Needed
1
Research Sites
231 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Tafasitamab, Retifanlimab, and Rituximab in Combination With Standard Therapy for the Treatment of Diffuse Large B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with untreated diffuse large B-cell lymphoma or grade 3B follicular lymphoma, including composite, transformed, or discordant lymphomas
- Patients with high grade B-cell lymphoma not eligible for or declining intensive therapy
- Willing and able to provide written informed consent
- Age 18 years or older at consent
- Measurable disease with at least one nodal site ≥1.5 cm or extranodal site ≥1.0 cm on CT or FDG-PET
- ECOG performance status of 0 to 2
- Absolute neutrophil count ≥ 1,000/mcL (except marrow infiltration cases)
- Platelets ≥ 75,000/mcL (except marrow infiltration cases)
- Creatinine clearance ≥ 30 mL/min (measured or calculated)
- Total bilirubin ≤ 1.5 x ULN unless Gilbert's syndrome or liver involvement (allowed up to 5 x ULN)
- AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN with liver metastases
- Left ventricular ejection fraction ≥ 45%
- Female subjects of childbearing potential must have negative pregnancy test within 72 hours before first dose and agree to use two birth control methods or abstain during and 180 days after treatment
- Male subjects must agree to use two methods of contraception during and 180 days after treatment
You will not qualify if you...
- Currently participating in another investigational study or using an investigational device within 4 weeks
- Require systemic corticosteroids > 10 mg/day prednisone equivalent (with exceptions for physiologic replacement and brief courses)
- Diagnosis of immunodeficiency
- Known progressing malignancy requiring active treatment (except certain skin or in situ cancers)
- Active CNS metastases or carcinomatous meningitis
- Evidence or history of interstitial lung disease or active noninfectious pneumonitis
- Active infection requiring IV antibiotics at treatment start
- History of organ transplant including stem cell transplant
- Received live vaccine within 28 days before treatment
- Conditions or abnormalities that may interfere with trial participation or data
- Known psychiatric or substance abuse disorders interfering with trial cooperation
- Pregnant, breastfeeding, or planning conception during trial period
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies
- Known HIV infection unless controlled with CD4 > 200/uL
- Known active Hepatitis B or Hepatitis C infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
S
Stephen D. Smith
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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