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NCT Number: NCT05519579

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

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.

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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

methotrexate

Drug

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

Blinatumomab

Drug

Blinatumomab 28ug/day continuous infusion for 4 weeks

Primary outcomes

  1. Number of participants that experienced neurotoxicity during the first cycle of blinatumomab therapy

    Time frame: 28 days after first infusion

    Record occurrence and severity of neurotoxicity based on CTCAE criteria

Secondary outcomes

  1. Number of participants that experienced cytokine release syndrome during the first cycle of blinatumomab therapy

    Time frame: 28 days after first infusion

    Record occurrence and severity of cytokine release syndrome based on CTCAE criteria

  2. Number of participants with a response of complete remission and MRD negativity at the end of cycle 1

    Time frame: 28 days after first infusion

    Conduct disease restaging assessments, such as bone marrow biopsies and lumbar punctures, to determine response to treatment

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Northside Hospital, Inc.

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2022
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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