Phase 2: testing Cytarabine for Hematopoietic and Lymphatic System Neoplasm
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.
Official registry: https://clinicaltrials.gov/study/NCT06895473 · OHSU Knight Cancer Institute · enrollment listed as 26
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Biospecimen Collection, Cytarabine, or Lumbar Puncture. The registry lists allocation as na. 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.
They plan to enroll about 26 people at Portland. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.
Official title (unrewritten)
A Phase 2 Study of Prophylactic IT Chemotherapy to Prevent High-Grade Chimeric Antigen Receptor (CAR) T-Cell-Associated Neurotoxicity Syndrome
Interventions: Biospecimen Collection, Cytarabine, Lumbar Puncture, Methotrexate, Therapeutic Hydrocortisone
Primary outcome (registry wording): Incidence of American Society for Transplantation and Cellular Therapy (ASTCT) ≥ grade 3 immune-effector cell associated neurotoxicity syndrome (ICANS)
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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
- 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
Who the registry excludes
- Active/concurrent diagnosis of any central nervous system (CNS) hematologic malignancy
- History or presence of CNS disorder such as seizure disorder, 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
Contact
No central phone on the registry card. Use the official listing to reach a site.
Sites listed on ClinicalTrials.gov
1 listed- OHSU Knight Cancer Institute — Portland, Oregon (recruiting)
FAQ about this NCT record
Is NCT06895473 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06895473?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06895473?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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