MedTrace Logo

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

NCT05519579 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Methotrexate

Methotrexate 12mg given intrathecally within 24 hours prior to blinatumomab administration

DRUG

Blinatumomab

Blinatumomab 28ug/day continuous infusion for 4 weeks

Sponsors & Collaborators

  • Northside Hospital, Inc.

    lead OTHER

Principal Investigators

  • Melhem Solh, MD · Blood and Marrow Transplant Group of Georgia

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2026-11-01
Completion
2026-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05519579 on ClinicalTrials.gov