1336GCC: Study of Erwinaze for Treatment of Acute Myeloid Leukemia (AML)
Status:
Completed
Trial end date:
2017-09-01
Target enrollment:
Participant gender:
Summary
Erwinaze will be administered intravenously at a dose of 25,000 IU/m2 (dose cohort 0) for 6
doses MWF over a period of 2 weeks to 9 patients (as described below and in the following
schema). Blood counts, chemistries including bilirubin, amylase and lipase, and coagulation
studies including fibrinogen will be measured and reviewed before each asparaginase dose.
Fibrinogen (<100 mg/dL) can be replaced with cryoprecipitate before each dose at the
discretion of treating physician. Treatment will be stopped for elevation of amylase, lipase
or direct bilirubin above normal range.