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.
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
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
Single group
Methotrexate
DrugMethotrexate 12mg given intrathecally within 24 hours prior to blinatumomab administration
Blinatumomab
DrugBlinatumomab 28ug/day continuous infusion for 4 weeks
Number of participants that experienced neurotoxicity during the first cycle of blinatumomab therapy
Record occurrence and severity of neurotoxicity based on CTCAE criteria
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
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