Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia
Sponsor: Northside Hospital, Inc.
ClinicalTrials ID:NCT05519579
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
| Parameter | Options |
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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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Northside Hospital | 30342 | Atlanta | Georgia |
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