1336GCC: Study of Erwinaze for Treatment of Acute Myeloid Leukemia (AML)

• Status: Completed
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ashkan Emadi
• Treatments: Asparaginase

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed AML

• 18 years and older

• AML has relapsed after, or is refractory to, first-line therapy, with or without subsequent additional therapy

• Have received or are ineligible for immediate established curative regimens

• ASCT patients are eligible provided that they are >= 4 weeks from stem cell infusion

• alloSCT patients are eligible if they are >= 60 days post stem cell infusion, have no evidence of graft versus host disease (GVHD) > Grade 1, and are >= 2 weeks off all immunosuppressive therapy

• Previous cytotoxic chemotherapy completed at least 3 weeks and radiotherapy at least 2 weeks prior to day 1 of study treatment

• Biologic agents stopped at least 1 week prior to day 1 of study treatment

• DNA methyltransferase inhibitors stopped at least 3 weeks prior to day 1 of study treatment

• ECOG performance status ≤2

• Patients must have normal organ function

• Female patients of childbearing potential must have a negative pregnancy test.

• Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

• Patients receiving any other investigational agents, or concurrent chemotherapy, radiation therapy, or immunotherapy

• Patients with acute promyelocytic leukemia

• Patients with active central nervous system leukemia

• Prior treatment with Erwinaze

• Hyperleukocytosis with > 50,000 blasts/μL

• History of a major thrombotic event

• History of pancreatitis

• Active, uncontrolled infection

• Uncontrolled intercurrent illness

• Pregnant women

• Uncontrolled active seizure disorder or a history of seizure