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

Inclusion Criteria:

• Adults receiving first cycle of blinatumomab for relapse/refractory or MRD-positiveB-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, Cerebrovascularischemia/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 wasdeemed to interfere with the conduct of the study as judged by the investigator