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. Cytarabine is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in the body. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make DNA and may kill cancer cells. Anti-inflammatory drugs, such as hydrocortisone, lower the body’s immune response and are used with other drugs in the treatment of some types of cancer. Giving IT cytarabine, methotrexate, and hydrocortisone may prevent high-grade ICANS in patients receiving CAR T-cell therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06895473.
Locations matching your search criteria
United States
Oregon
Portland
OHSU Knight Cancer InstituteStatus: Active
Contact: Stephen E.F. Spurgeon
Phone: 503-494-8950
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 any grade ICANS.
II. To evaluate safety of IT chemotherapy.
III. To evaluate the effect of IT chemotherapy on corticosteroid use.
IV. To evaluate the effect of IT chemotherapy on anakinra use.
EXPLORATORY OBJECTIVES:
I. To evaluate the effect of IT chemotherapy on time to ICANS onset.
II. To evaluate the effect of IT chemotherapy on duration of ICANS.
III. To evaluate the burden of treatment mediated serious adverse events (SAEs).
OUTLINE:
Patients receive cytarabine IT, methotrexate IT, and hydrocortisone IT over 3-5 minutes via lumbar puncture (LP) on day 4 post-standard of care (SOC) CAR T-cell therapy in the absence of unacceptable toxicity or development of ICANS. Patients who do not develop ICANS of any grade, also receive hydrocortisone IT on day 7 post SOC CAR T-cell therapy. Additionally, patients undergo cerebrospinal fluid (CSF) sample collection throughout the study.
After completion of study treatment, patients are followed for up to 30 days.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationOHSU Knight Cancer Institute
Principal InvestigatorStephen E.F. Spurgeon
