Actively Recruiting
Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia
Led by Northside Hospital, Inc. · Updated on 2026-04-20
20
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 performance status of 0 to 2
You will not qualify if you...
- Active central nervous system involvement by Acute Lymphoblastic Leukemia
- History of neurological disorders including seizure, paresis, aphasia, cerebrovascular ischemia or hemorrhage, severe brain injury, dementia, Parkinson's disease, cerebellar disease, psychosis, or coordination/movement disorders
- Contraindication to receive intrathecal methotrexate
- Prior treatment with blinatumomab
- Active malignancy other than Acute Lymphoblastic Leukemia
- Active infection or any other medical condition that could interfere with study participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Northside Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
Research Team
C
Caitlin Guzowski
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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