Overview

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