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Anakinra in Preventing Severe Chimeric Antigen Receptor T-Cell Related Encephalopathy Syndrome in Patients With Recurrent or Refractory Large B-cell Lymphoma

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Brief Summary

This phase II trial studies how well anakinra works in preventing severe chimeric antigen receptor T-cell-related encephalopathy syndrome after chimeric antigen receptor T-cell therapy in patients with large B-cell lymphoma that has come back or has not responded to treatment. Immunosuppressive therapy, such as anakinra, is used to decrease the body?s immune response, which may prevent severe chimeric antigen receptor T-cell-related encephalopathy syndrome.

Primary Purpose
Prevention
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • Patients with relapsed or refractory large B-cell lymphoma that has progressed on two prior lines of therapy, who meet the indication for the Food and Drug Administration (FDA)-approved therapy axicabtagene ciloleucel
  • Large B-cell lymphoma includes diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma
  • The above includes patients with progressive or stable disease as the best response to the most recent treatment regimen or disease progression within 12 months after autologous hematopoietic stem cell transplantation
  • Patients with central nervous system (CNS) involvement of large B-cell lymphoma that originated outside of the CNS will be included (not primary CNS lymphoma)
  • Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 2.5 upper limit of normal
  • Total bilirubin =< 2.0 mg/dL
  • Creatinine clearance > 30 mL/min based on Cockcroft-Gault formula
  • Patients with human immunodeficiency virus (HIV) who have an undetectable viral load will be included
  • Deemed competent to make medical decisions

Exclusion Criteria:

  • Patients who receive CAR T-cell therapy with a product other than axicabtagene ciloleucel
  • Primary CNS lymphoma
  • Transformed DLBCL from chronic lymphocytic leukemia (CLL)
  • Burkitt?s lymphoma
  • Bridging chemotherapy completed < 7 days prior to CAR T-cell lymphodepleting chemotherapy
  • In patients who receive bridging chemotherapy, positron emission tomography (PET)-computed tomography (CT) or CT of chest, abdomen, pelvis was not done after bridging chemotherapy prior lympho-depleting therapy
  • Most recent PET-CT or CT of all known disease is sites done more than 6 weeks prior to CAR T-cell infusion
  • Any individual CNS tumor mass > 2 cm
  • History of autologous hematopoietic stem cell transplantation administered less than 100 days prior to CAR T-cell infusion
  • History of allogeneic hematopoietic stem cell transplantation
  • Treatment with alemtuzumab within 6 months prior to leukapheresis, or treatment with clofarabine or cladribine within 3 months prior to leukapheresis
  • Less than 3 half-lives elapsed since receiving immune checkpoint inhibitor (pembrolizumab, ipilimumab, nivolumab, atezolizumab, etc.)
  • Presence of uncontrolled fungal, bacterial, or viral infection that require intravenous (IV) antimicrobial treatment
  • History of autoimmune disease resulting in end-organ damage, or autoimmune disease requiring systemic immunosuppressants or disease-modifying antirheumatic drug (DMARDs) within the past 6 months
  • Hypersensitivity to E. Coli-derived proteins
  • Patients with HIV who have a detectable viral load
  • Pregnant or nursing
  • Fertile women who decline use of contraception during the study period

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Study Stats
Protocol No.
19-000604
Category
Hematology-Oncology
Oncology
Contact
Caspian Oliai
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT04205838
For detailed technical eligibility, visit ClinicalTrials.gov.