Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05519579

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Northside Hospital

Atlanta, Georgia, United States, 30342

Actively Recruiting

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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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