Study on Using Intrathecal Chemotherapy to Prevent Nerve Side Effects in Blinatumomab Treatment for Acute Lymphoblastic Leukemia

Sponsor: Northside Hospital, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05519579

Provider View

This clinical trial is testing a new schedule for giving chemotherapy directly into the spinal fluid to help prevent nerve-related side effects in patients receiving blinatumomab for Acute Lymphoblastic Leukemia (ALL).

Patient Parameters

Program Overview

The aim of this study is to see if changing the timing of chemotherapy given directly into the spinal fluid can help maintain the cancer-fighting effects of blinatumomab while reducing nerve-related side effects. This approach is being tested in patients with Acute Lymphoblastic Leukemia (ALL) to see if it can help manage the side effects associated with the treatment.

Eligibility Criteria

Inclusion Criteria

  • Adults starting their first cycle of blinatumomab for relapsed or difficult-to-treat B-cell Acute Lymphoblastic Leukemia (ALL) or those with minimal residual disease (MRD)-positive ALL.
  • Must have good kidney and liver function.
  • Must test negative for HIV.
  • Women of childbearing potential must have a negative pregnancy test.
  • Must be in good overall health with an ECOG performance status of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.

Exclusion Criteria

  • Active involvement of the central nervous system (CNS) by ALL.
  • Existing CNS disorders such as seizures, paralysis, speech difficulties, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, psychosis, or movement disorders.
  • Cannot receive chemotherapy directly into the spinal fluid (intrathecal methotrexate).
  • Previous treatment with blinatumomab.
  • Active cancer other than ALL.
  • Active infection or any other medical condition that could interfere with the study, as determined by the study doctor.

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