💬In plain words
What the trial is, and whether it could suit you
This phase II trial tests how well cytarabine (Ara-C), methotrexate, and hydrocortisone given between the spinal cord and the membranes that protect it (intrathecal \[IT\]) works in preventing high-grade immune effector-associated neurotoxicity syndrome (ICANS) in patients receiving chimeric antigen receptor (CAR) T-cell therapy. ICANS is a challenging complication of CAR T-cell therapy that causes neurological effects varying from mild headaches or temporary confusion to hallucinations, swelling in the brain, and seizures. Between 20%-70% of patients receiving CAR T-cell therapy show symptoms of neurotoxicity.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Written informed consent. Participant or legally authorized representative (LAR) must provide written informed consent prior to any study-specific procedures or interventions
* Age ≥ 18 years. All genders, races, and ethnic groups will be included
* Must be receiving SOC Yescarta® or Tecartus® in the inpatient setting
* Agree to adhere to institutional guidelines for contraception during the first 30 days post CAR-T
* Rationale for eligibility criteria based on contraception and pregnancy (both participants and partners of a sperm-producing participant): It shall be known to all participants that the effects of CAR-T or IT chemotherapy on the developing human fetus are unknown. For this reason, persons of reproductive potential must agree to use adequate contraception. Should a participant or participant's sexual partner become pregnant or suspect a pregnancy while participating in this study, the individual should inform their treating physician immediately
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Platelet count \> 50,000/mm\^3 (μL)
* Adequate coagulation tests including international normalized ratio (INR) \< 1.6 and fibrinogen \> 100
Exclusion Criteria:
* Active/concurrent diagnosis of any central nervous system (CNS) hematologic malignancy
* History or presence of CNS disorder such as poorly controlled seizure disorder (seizure within the 12 months), transverse myelitis, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
* Known history of hypersensitivity to IT chemotherapy
* Subject has a contraindication to LP including:
* Presence of a posterior fossa mass
* Skin infection near puncture site
* Uncorrected bleeding diathesis
* Suspicion of increased intracranial pressure
* Acute spinal cord trauma
* Subject is receiving an antiplatelet and/or anticoagulant that cannot be held prior to LP according to best available evidence
* Known bleeding disorders
* Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgement, make the participant inappropriate for study participation or would put the participant at risk
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