Clinical trial · Interventional
Anakinra in Preventing Severe Chimeric Antigen Receptor T-Cell Related Encephalopathy Syndrome in Patients With Recurrent or Refractory Large B-cell Lymphoma
IL-1 Receptor Antagonist to Prevent Severe Chimeric Antigen Receptor T-Cell Related Encephalopathy Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-Cell Lymphoma, Not Otherwise Specified | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| High Grade B-Cell Lymphoma | High Grade B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Progressive Disease | — | UNRESOLVED | — |
| Recurrent Diffuse Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Recurrent High Grade B-Cell Lymphoma | High Grade B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Recurrent Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma | — | UNRESOLVED | — |
| Recurrent Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma | Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anakinra | Biological | — | UNRESOLVED |
| Axicabtagene Ciloleucel | Biological | Axicabtagene Ciloleucel | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Fludarabine Phosphate | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prevention (anakinra, CAR T-cell therapy)
- description
- Patients receive standard lymphodepleting therapy including fludarabine and cyclophosphamide on days -5 to -3, then receive axicabtagene ciloleucel CAR T-cell infusion. Patients with clinical evidence of ICANS of any grade, or CRS \>= grade 3 receive anakinra SC every 6-12 hours for 12-36 doses over 9 days in the absence of unacceptable toxicity.
- interventionNames
- Biological: Anakinra
- Biological: Axicabtagene Ciloleucel
- Drug: Cyclophosphamide
- Drug: Fludarabine
- Drug: Fludarabine Phosphate
Primary outcomes (2)
- measure
- Number of patients who met the eligibility criteria to receive and did receive anakinra
- timeFrame
- Up to 12 months
- description
- The study will be considered feasible if 8 study participants are enrolled over 12 months at University of California, Los Angeles.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available