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

• Status: Not yet recruiting
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northside Hospital, Inc.
• Treatments: Blinatumomab; Methotrexate

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