Study on Tafasitamab, Retifanlimab, and Rituximab with Standard Therapy for Treating Diffuse Large B-cell Lymphoma

Sponsor: University of Washington

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05455697

Provider View

This clinical trial is testing a new combination of drugs, including tafasitamab, retifanlimab, and rituximab, with standard chemotherapy to treat patients with diffuse large B-cell lymphoma who have not received prior treatment. The study aims to determine if this combination is safe and effective in killing cancer cells.

Patient Parameters

Program Overview

This study is exploring whether a combination of three drugs—tafasitamab, retifanlimab, and rituximab—can be safely added to standard chemotherapy treatments for patients with diffuse large B-cell lymphoma (DLBCL) who have not been treated before. These drugs are monoclonal antibodies that help the immune system target and destroy cancer cells. The standard chemotherapy includes drugs like cyclophosphamide, doxorubicin, vincristine, and prednisone, which work by stopping cancer cells from growing and spreading. The study aims to see if this new combination can kill more cancer cells than the standard treatment alone.

Description

Study Outline:

Prephase Therapy:

  • Patients receive tafasitamab through an IV for 30 minutes on days 1, 8, and 15 of each cycle.
  • Rituximab and hyaluronidase are given under the skin on day 1 of each cycle.
  • Retifanlimab is given through an IV for 30 minutes on day 8 of each cycle.
  • This treatment is repeated every 21 days for 2 cycles unless the disease worsens or side effects are too severe.

Combination Therapy:

  • After prephase therapy, or if the disease progresses, patients receive:
    • Tafasitamab, retifanlimab, rituximab, cyclophosphamide, doxorubicin, and vincristine through an IV on day 1 of each cycle.
    • Patients with a higher risk score may receive polatuzumab vedotin instead of vincristine.
    • Prednisone is taken orally on days 1-5 of each cycle.
  • This treatment is repeated every 21 days for 4-6 cycles unless the disease worsens or side effects are too severe.

Additional Procedures:

  • Optional bone marrow biopsy and aspiration, heart scan, and PET/CT scans.
  • Blood and tissue samples are collected throughout the trial.

Follow-Up:

  • After completing the study treatment, patients are followed up at 4-6 weeks, 12 weeks, and then as per routine care for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with untreated diffuse large B-cell lymphoma or grade 3B follicular lymphoma.
  • Willing to provide written consent to participate.
  • Have measurable disease with at least one tumor site of a certain size.
  • Good overall health with a performance status score of 0-2.
  • Adequate blood cell counts and organ function as determined by specific tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control during the study and for 180 days after.
  • Men must agree to use contraception during the study and for 180 days after.

Exclusion Criteria

  • Currently participating in another study or using an investigational device.
  • Requires high doses of corticosteroids, except for certain conditions.
  • Has a diagnosis of immunodeficiency or another progressing cancer.
  • Has active brain metastases or lung disease.
  • Has an active infection requiring IV antibiotics.
  • History of organ transplant.
  • Received a live vaccine within 28 days before starting the study.
  • Has conditions or treatments that could interfere with the study.
  • Pregnant, breastfeeding, or planning to conceive during the study.
  • Previous treatment with certain immune therapies.
  • Known HIV, Hepatitis B, or Hepatitis C infections unless controlled.

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