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

Sponsor: Northside Hospital, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05519579

Patient View

This clinical trial evaluates the timing of intrathecal methotrexate to mitigate neurotoxicity in adults with relapsed/refractory or MRD-positive B-cell Acute Lymphoblastic Leukemia undergoing blinatumomab therapy. Eligible participants must have adequate renal and hepatic function, be HIV-negative, and have an ECOG score of 0-2. Methotrexate is administered intrathecally before blinatumomab infusion.

Patient Parameters

Program Overview

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

Get This Program In Your Inbox

You can sign up and apply your patients for this program.