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Intrathecal Methotrexate to Prevent Blinatumomab Neurotoxicity in ALL

This study is looking at whether giving methotrexate directly into the spinal fluid (intrathecal chemoprophylaxis) before and during blinatumomab treatment can reduce nerve-related side effects (neurotoxicity) in adults with Acute Lymphoblastic Leukemia (ALL). You might be able to join if you are an adult receiving your first cycle of blinatumomab for ALL that has come back or is hard to treat, or if you have minimal residual disease (MRD-positive). The study aims to see how many participants experience neurotoxicity during the first 28 days of blinatumomab therapy. The study plans to enroll 20 participants, but its current status is unclear.

Study design
This study is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 20 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for neurotoxicity during the first cycle of blinatumomab therapy, measured at 28 days after the first infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05519579

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

Recruiting
PHASE2Ages 18+InterventionalPrevention
Northside Hospital, Inc.
~20 participants
Updated 2026-04-20 on ClinicalTrials.gov
What's tested:MethotrexateBlinatumomab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants that experienced neurotoxicity during the first cycle of blinatumomab therapy
Measured over 28 days after first infusion

Conditions

Acute Lymphoblastic Leukemia

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NCT05519579

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Northside Hospital

    Atlanta, Georgiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

Caitlin Guzowski
[email protected]
404-851-8523
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of participants that experienced neurotoxicity during the first cycle of blinatumomab therapy28 days after first infusion

    Record occurrence and severity of neurotoxicity based on CTCAE criteria