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Kent Holland, MD","SUB_INVESTIGATOR",{"name":77,"role":75,"phone":20,"phoneExt":20,"email":20},"Asad Bashey, MD",{"name":79,"role":75,"phone":20,"phoneExt":20,"email":20},"Lawrence E Morris, MD",{"name":81,"role":75,"phone":20,"phoneExt":20,"email":20},"Scott Solomon, MD",{"name":46,"role":48,"phone":20,"phoneExt":20,"email":20},{"name":84,"role":75,"phone":20,"phoneExt":20,"email":20},"Lizamarie Bachier-Rodriguez, MD",{"type":86,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100479176",false,"NCT05519579","Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Adults receiving first cycle of blinatumomab for relapse\u002Frefractory or MRD-positive B-cell Acute Lymphoblastic Leukemia\n* Adequate renal and hepatic function\n* Negative for HIV\n* Negative serum pregnancy test, if applicable\n* ECOG 0-2\n\nExclusion Criteria:\n\n* Active CNS involvement by ALL\n* Relative CNS disorders (seizure, paresis, aphasia, Cerebrovascular ischemia\u002Fhemorrhage, severe brain injury, dementia, Parkinson's, cerebellar disease, psychosis, coordination or movement disorder)\n* Contraindication to receive intrathecal methotrexate\n* Prior treatment with blinatumomab\n* Active malignancy other than ALL\n* 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","ALL","18 Years",{"count":95,"type":96},20,"ESTIMATED","INTERVENTIONAL",[99],"PHASE2","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.",[102],"Acute Lymphoblastic Leukemia","2026-04-15",{"date":105,"type":106},"2026-04-20","ACTUAL",{"date":108,"type":106},"2023-06-30",{"date":110,"type":96},"2026-12-01",{"name":5,"class":6},1]