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Recruiting

Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia

NCT05519579 · Northside Hospital, Inc.
In plain English

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About this study
Changing the schedule of intrathecal chemotherapy to be given before and during blinatumomab will maintain the anti-leukemic effects of this drug while at the same time adding the benefit of limiting the neurotoxicity associated with cytokine release.
Eligibility criteria
Inclusion Criteria: * Adults receiving first cycle of blinatumomab for relapse/refractory or MRD-positive B-cell Acute Lymphoblastic Leukemia * Adequate renal and hepatic function * Negative for HIV * Negative serum pregnancy test, if applicable * ECOG 0-2 Exclusion Criteria: * Active CNS involvement by ALL * Relative CNS disorders (seizure, paresis, aphasia, Cerebrovascular ischemia/hemorrhage, severe brain injury, dementia, Parkinson's, cerebellar disease, psychosis, coordination or movement disorder) * Contraindication to receive intrathecal methotrexate * Prior treatment with blinatumomab * Active malignancy other than ALL * Active infection or any other concurrent disease or medical condition that was deemed to interfere with the conduct of the study as judged by the investigator
Study design
Enrollment target: 20 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-06-30
Estimated completion: 2026-12-01
Last updated: 2026-04-20
Interventions
Drug: MethotrexateDrug: Blinatumomab
Primary outcomes
  • Number of participants that experienced neurotoxicity during the first cycle of blinatumomab therapy (28 days after first infusion)
Sponsor
Northside Hospital, Inc. · other
Contacts & investigators
ContactCaitlin Guzowski · contact · caitlin.guzowski@northside.com · 404-851-8523
InvestigatorMelhem Solh, MD · principal_investigator, Blood and Marrow Transplant Group of Georgia
All locations (1)
Northside HospitalRecruiting
Atlanta, Georgia, United States
Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia · TrialPath