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RecruitingInterventionalPhase 2

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

NCT ID: NCT05519579Sponsor: Northside Hospital, Inc.Last updated: 2026-04-20

Summary

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.

Arms & interventions

  • DrugMethotrexate

    Methotrexate 12mg given intrathecally within 24 hours prior to blinatumomab administration

  • DrugBlinatumomab

    Blinatumomab 28ug/day continuous infusion for 4 weeks

Outcome measures

Primary

  • Number of participants that experienced neurotoxicity during the first cycle of blinatumomab therapy

    Record occurrence and severity of neurotoxicity based on CTCAE criteria

    Time frame: 28 days after first infusion

Secondary

  • Number of participants that experienced cytokine release syndrome during the first cycle of blinatumomab therapy

    Time frame: 28 days after first infusion

  • Number of participants with a response of complete remission and MRD negativity at the end of cycle 1

    Time frame: 28 days after first infusion

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

Northside Hospital

Atlanta, Georgia, 30342

Recruiting
Caitlin Guzowski, MBA, MHA · Contact
404-851-8523caitlin.guzowski@northside.com
H. Kent Holland, MD · Sub Investigator
Asad Bashey, MD · Sub Investigator
Lawrence E Morris, MD · Sub Investigator
Scott Solomon, MD · Sub Investigator
Melhem Solh, MD · Principal Investigator
Lizamarie Bachier-Rodriguez, MD · Sub Investigator

References

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