Hematopoietic and Lymphoid Cell Neoplasm Clinical Trial
Official title:
Pilot Study of Anakinra to Mitigate CAR-T Toxicity in Subjects With Relapsed or Refractory Large B-Cell Lymphoma
This phase II trial studies the side effects and best dose of anakinra and to see how well it works in reducing side effects (toxicity) associated with a CAR-T cell treatment called axicabtagene ciloleucel in patients with large B-cell lymphoma that has come back (relapsed) or has not responded to treatment (refractory). Anakinra is a drug typically used to treat rheumatoid arthritis but may also help in reducing CAR-T cell therapy toxicity. Giving anakinra in combination with axicabtagene ciloleucel may help control relapsed or refractory large B-cell lymphoma.
PRIMARY OBJECTIVE: I. To assess safety and tolerability of anakinra in reducing incidence of cytokine release syndrome (CRS) within 30 days after infusion of chimeric antigen receptor (CAR) T cells in subjects with relapsed or refractory large B-cell lymphoma. SECONDARY OBJECTIVES: I. To determine incidence of all grades and duration of both CRS and immune-cell associated neurotoxicity syndrome (ICANS). II. To determine the complete response rate (CRR), overall response rate (ORR), progression-free survival (PFS) and overall survival (OS). EXPLORATORY OBJECTIVES: I. To determine the effects of anakinra on the cytokine and chemokine profile in peripheral blood after CAR-T therapy. II. To determine the effects of anakinra on the expansion and persistence of CAR T cells. III. To correlate baseline characteristics with toxicity, response and survival after anakinra combined with CAR-T therapy. OUTLINE: This is a dose-escalation study of anakinra. Patients receive cyclophosphamide intravenously (IV) over 60 minutes and fludarabine IV over 30 minutes on days -5 to -3 in the absence of disease progression or unacceptable toxicity. Patients then receive axicabtagene ciloleucel IV over 30 minutes or less on day 0 and anakinra subcutaneously (SC) on days 0-6 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 2 and 4 weeks, and then at 2, 3, 6, 9, 12, 18, and 24 months. ;
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