Home › Acute Lymphoblastic Leukemia › NCT05519579

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

Who can join

Ages 18 and older · All sexes

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

About the study

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.

What is being tested

• Methotrexate (drug)
• Blinatumomab (drug)

Sponsor: Northside Hospital, Inc. · Participants: 20 · Started: Jun 30, 2023

Contact the study team

• Caitlin Guzowski · Phone: 404-851-8523

Official record on ClinicalTrials.gov — NCT05519579

Locations in the U.S.

Conditions

• Acute Lymphoblastic Leukemia

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.