Anakinra for the Reduction of CAR-T Toxicity in Patients With Relapsed or Refractory Large B-cell… (NCT04432506) | Clinical Trial Compass
CompletedPhase 2
Anakinra for the Reduction of CAR-T Toxicity in Patients With Relapsed or Refractory Large B-cell Lymphoma
United States22 participantsStarted 2020-07-27
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Relapsed or refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), transformed follicular lymphoma (tFL), or high-grade B-cell lymphoma (HGBCL), at least 2 prior lines of systemic therapy
* Planned to receive standard of care therapy with axicabtagene ciloleucel
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Measurable disease of \>= 1.5 cm
* At least two weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for axicabtagene ciloleucel (axi-cel) therapy, except for systemic immune checkpoint inhibitory / immune stimulatory therapy. At least 3 half-lives must have elapsed from any prior systemic immune checkpoint inhibitory / immune stimulatory therapy at the time the subject is planned for leukapheresis (e.g. ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc)
* Toxicities due to prior therapy must be stable and recovered to =\< grade 1 (except for clinically non-significant toxicities such as alopecia)
* Absolute neutrophil count of \>= 1.0 x 10\^9/L
* Platelet count of \>= 60 x 10\^9/L
* Creatinine clearance (as estimated by Cockcroft Gault) \>= 45 mL/minute (min)
* Serum alanine transaminase (ALT) / aspartate transaminase (AST) =\< 2.5 upper limit of normal (ULN)
* Total bilirubin =\< 1.5 mg/dL, except in subjects with Gilbert's syndrome
* Cardiac ejection fraction \>= 50%…
What they're measuring
1
Incidence of Any Grade Cytokine Release Syndrome (CRS)
Timeframe: Within 30 days after infusion of CAR T cells