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

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 35 to confirmed 33 · Primary completion date: Jan 5, 2027 to Oct 15, 2026 · Completion date: Jul 6, 2027 to Jan 7, 2027 · 1 morev14 Show 4 more changesShow less
    • Enrollment target: estimated 35 to confirmed 33
    • Primary completion date: Jan 5, 2027 to Oct 15, 2026
    • Completion date: Jul 6, 2027 to Jan 7, 2027
    • Site details revised
  2. Re-verified, no change to tracked fieldsv13
  3. Primary completion date: Jan 5, 2026 to Jan 5, 2027 Completion date: Jul 6, 2026 to Jul 6, 2027v12 Show 1 more changeShow less
    • Completion date: Jul 6, 2026 to Jul 6, 2027
  4. Re-verified, no change to tracked fieldsv11
  5. Interventions: Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Computed Tomography (Procedure)… to Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Computed Tomography (Procedure)… Study description expanded, about 22 words · Site contact updated · Study title shortened, about 4 wordsv10 Show 3 more changesShow less
    • Study description expanded, about 22 words
    • Site contact updated
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

Show 8 earlier versionsHide 8 earlier versions
  1. Re-verified, no change to tracked fieldsv9
  2. Interventions: Biopsy (Procedure), Cyclophosphamide (Drug), Doxorubicin (Drug), Prednisone (Drug), Retifanlimab (Biological), Rituximab and Hyaluronidase… to Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Computed Tomography (Procedure)… Study description expanded, about 35 wordsv8 Show 1 more changeShow less
    • Study description expanded, about 35 words

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv7
  4. Start date changed from estimate of Feb 17, 2023 to Jan 26, 2023v6
  5. Start date: Jan 7, 2023 to Feb 17, 2023v5
  6. Trial status: Not Yet Recruiting to Recruiting Start date: Dec 15, 2022 to Jan 7, 2023 · Site details revisedv4 Show 2 more changesShow less
    • Start date: Dec 15, 2022 to Jan 7, 2023
    • Site details revised
  7. 2 versions Re-verified since Jul 12, 2022, no change to tracked fieldsv2-v3
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05455697
Lead Sponsor University of Washington
Conditions Diffuse Large B-Cell Lymphoma, Grade 3b Follicular Lymphoma, High Grade B-Cell Lymphoma
Enrollment 33 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov