RecruitingPhase 2NCT05519579

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


Sponsor

Northside Hospital, Inc.

Enrollment

20 participants

Start Date

Jun 30, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether injecting a small dose of methotrexate (a chemotherapy drug) directly into the spinal fluid (intrathecal) can prevent a serious brain side effect called neurotoxicity in patients receiving blinatumomab — a treatment for a type of blood cancer called B-cell acute lymphoblastic leukemia (ALL). **You may be eligible if...** - You are an adult receiving your first cycle of blinatumomab for relapsed, treatment-resistant, or MRD-positive B-cell ALL - Your kidney and liver function are adequate - You are HIV-negative - Your overall health status is reasonably good (ECOG 0–2) **You may NOT be eligible if...** - The cancer has already spread to your central nervous system (brain or spinal cord) - You have certain neurological conditions (seizures, stroke, paralysis, dementia, Parkinson's, or movement disorders) - You cannot receive intrathecal methotrexate (for medical reasons) - You have already been treated with blinatumomab before - You have another active cancer - You have an active serious infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMethotrexate

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

DRUGBlinatumomab

Blinatumomab 28ug/day continuous infusion for 4 weeks


Locations(1)

Northside Hospital

Atlanta, Georgia, United States

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NCT05519579


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