Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

StatusRecruiting
PhasePhase 2
Started

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Record History

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  1. Minor Trial sites expanded: 87 → 95 locations
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: details revised at 2 of 5 entries
    • Study description revised
  2. Notable Primary completion date: Dec 31, 2025 to Jun 30, 2030
    • Study completion date: Dec 4, 2029 to Jun 30, 2030
    v12
  3. Minor Study sites: 76 to 87v11
  4. Minor Study sites: 64 to 76v10
  5. Minor Study sites: 35 to 64v9
Show 7 earlier versionsHide 7 earlier versions
  1. Notable Primary completion date: Dec 4, 2024 to Dec 31, 2025v8
  2. Minor Study sites: 1 to 35v7
  3. Notable Start date: Feb 23, 2023 to Jun 12, 2023v6
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 4, 2023 to Feb 23, 2023
    v5
  5. Minor Collaborators: 1 to 2v4
  6. Notable Start date: Dec 4, 2022 to Feb 4, 2023v3
  7. Minor Study title shortened, about 8 wordsv2
  1. Minor Study First Submitted
  • 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 II trial tests whether mosunetuzumab and/or polatuzumab vedotin helps benefit patients who have received chemotherapy (fludarabine and cyclophosphamide) followed by chimeric antigen receptor (CAR) T-cell therapy (tisagenlecleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel) for diffuse large B-cell lymphoma that has come back (recurrent) or that does not respond to treatment (refractory) or grade IIIb follicular lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a drug called vedotin. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, and delivers vedotin to kill them. Chemotherapy drugs, such as fludarabine and cyclophosphamide, 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. CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving mosunetuzumab and/or polatuzumab vedotin after chemotherapy and CAR T-cell therapy may be more effective at controlling or shrinking the cancer than not giving them.
Trial Details
NCT Number NCT05633615
Lead Sponsor SWOG Cancer Research Network
Collaborators: National Cancer Institute (NCI), Genentech, Inc.
Conditions
(from sponsor)
Diffuse Large B-Cell Lymphoma, Grade 3b Follicular Lymphoma, Primary Mediastinal (Thymic) Large B-Cell Lymphoma, Recurrent Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Transformed Follic Lymph to Diff Large B-Cell Lymphoma, Transformed Marg Zone Lymph to Diff Large B-Cell Lymphoma
Related terms Lymphoma, Large B-Cell, Diffuse
Enrollment 396 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov