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

Recruiting now · Phase 2

Conditions studied: Acute Lymphoblastic Leukemia

In brief

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.

Key facts

Study ID

NCT05519579

Run by

Northside Hospital, Inc.

People needed

20

Starts

2023-06-30

Expected to finish

2026-12-01

Last updated by the study team

2026-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Northside Hospital — Atlanta, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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