Status:
NOT_YET_RECRUITING
Intrathecal Cytarabine, Methotrexate, and Hydrocortisone for the Prevention of High-Grade Chimeric Antigen Receptor T-Cell-Associated Neurotoxicity Syndrome
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
Oregon Health and Science University
American Society of Clinical Oncology
Conditions:
Hematopoietic and Lymphatic System Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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-gr...
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate the efficacy of IT chemotherapy in the prevention of high grade ICANS. SECONDARY OBJECTIVES: I. To evaluate the efficacy of IT chemotherapy in the prevention of an...
Eligibility Criteria
Inclusion
- 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
- Active/concurrent diagnosis of any central nervous system (CNS) hematologic malignancy
- History or presence of CNS disorder such as seizure disorder, 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
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06895473
Start Date
April 1 2025
End Date
December 31 2027
Last Update
March 26 2025
Active Locations (1)
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1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239