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

Status
Active
Cancer Type
Leukemia
Trial Phase
Phase II
Eligibility
18 Years and older (Adult, Older Adult ), Male and Female
Study Type
Treatment
NCT ID
NCT05519579
Protocol IDs
NSH 1354 (primary)
Study Sponsor
Northside Hospital

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.

Objectives

What is the study measuring?

Primary Outcome Measure: Number of participants that experienced neurotoxicity during the first cycle of blinatumomab therapy. Record occurrence and severity of neurotoxicity based on CTCAE criteria

Secondary Outcome Measure: Number of participants that experienced cytokine release syndrome during the first cycle of blinatumomab therapy. Record occurrence and severity of cytokine release syndrome based on CTCAE criteria.

Number of participants with a response of complete remission and MRD negativity at the end of cycle 1.Conduct disease restaging assessments, such as bone marrow biopsies and lumbar punctures, to determine response to treatment.

Eligibility

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 Sites in Georgia

Northside Hospital Cancer Institute - Bone Marrow Transplant (BMT)


1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-851-8523


**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.