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

Active:	Yes
Cancer Type:	Leukemia	NCT ID:	NCT05519579
Trial Phases:	Phase II	Protocol IDs:	NSH 1354 (primary)
Eligibility:	18 Years and older (Adult, Older Adult ), Male and Female	Study Type:	Treatment
Study Sponsor:	Northside Hospital
NCI Full Details:	https://clinicaltrials.gov/study/NCT05519579

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.

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.