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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
20
Methotrexate 12mg given intrathecally within 24 hours prior to blinatumomab administration
Blinatumomab 28ug/day continuous infusion for 4 weeks
Northside Hospital
Atlanta, Georgia, United States
RECRUITINGNumber of participants that experienced neurotoxicity during the first cycle of blinatumomab therapy
Record occurrence and severity of neurotoxicity based on CTCAE criteria
Time frame: 28 days after first infusion
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
Time frame: 28 days after first infusion
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
Time frame: 28 days after first infusion
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