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

Launched by JONSSON COMPREHENSIVE CANCER CENTER · Dec 17, 2019

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ClinConnect Summary

This clinical trial is studying how well a medication called anakinra can help prevent a serious condition called chimeric antigen receptor T-cell-related encephalopathy syndrome (CART-ES) in patients with certain types of aggressive lymphoma, specifically large B-cell lymphoma, that have either returned after treatment or did not respond to previous therapies. The trial is important because CART-ES can occur after a special type of cancer treatment known as CAR T-cell therapy, which helps the body fight cancer but can sometimes lead to severe side effects.

To participate in this trial, patients need to have had at least two prior treatments for their lymphoma and should be eligible for another FDA-approved treatment called axicabtagene ciloleucel. This includes people with different forms of large B-cell lymphoma and those whose disease has progressed following their last treatment. Participants can expect to receive anakinra along with their CAR T-cell therapy and will be closely monitored for any side effects. This trial is currently recruiting participants and is open to adults of all genders aged 65 to 74. If you think you might be eligible or have questions about participation, it’s a good idea to talk to your healthcare provider.

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ALL

Eligibility criteria

• 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