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

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT05455697
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Cyclophosphamide — DRUG
    Given IV
  • Doxorubicin — DRUG
    Given IV
  • Prednisone — DRUG
    Given PO
  • Retifanlimab — BIOLOGICAL
    Given IV
  • Rituximab and Hyaluronidase Human — BIOLOGICAL
    Given SC
  • Tafasitamab — BIOLOGICAL
    Given IV
  • Vincristine — DRUG
    Given vincristine
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Fludeoxyglucose F-18 — OTHER
    Undergo FDG-PET/CT
  • Positron Emission Tomography — PROCEDURE
    Undergo FDG-PET
  • Computed Tomography — PROCEDURE
    Undergo FDG-CT
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Polatuzumab Vedotin — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Jan 26, 2023
Status verified
Dec 2025
Primary completion
Jan 5, 2027
Completion
Jul 6, 2027

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (TRR, CHOP)
    PREPHASE THERAPY: Patients receive tafasitamab IV over 30 minutes on days 1, 8, and 15 of each cycle, rituximab and hyaluronidase human SC on day 1 of each cycle, and retifanlimab IV over 30 minutes on day 8 of each cycle. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. COMBINATION THERAPY: After completion of prephase therapy or if patients progress during prephase therapy, patients receive tafasitamab IV over 30 minutes, retifanlimab IV over 30 minutes, rituximab and hyaluronidase human SC, cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1 of each cycle. Patients with an IPI score of 2-5 may receive polatuzumab vedotin IV in place of vincristine at investigator discretion. Patients also receive prednisone PO on days 1-5 of each cycle. Treatment repeats every 21 days for 4-6 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Dose limiting toxicity rate [ Time Frame: From treatment start to end of cycle 3 (each cycle is 3 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Stephen D. Smith
[email protected]
206-606-6546
Stephen D. Smith (PRINCIPAL_INVESTIGATOR)

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By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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