Efficacy and Safety Study of Recombinant Human Arginase 1 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Inclusion Criteria:

1. Adult patients ≥18 year-old at the time of informed consent
2. Documented relapsed or refractory AML after at least two standard chemotherapy regimen or in whom the treating physicians considered unfit for further chemotherapy treatment
3. The Eastern Cooperative Oncology Group (ECOG) performance status equal or less than 2
4. Patients from whom valid consent is obtained

Exclusion Criteria:

1. Patients who have received any induction chemotherapy, investigational treatment and arginine depleting agent within 2 weeks prior to the start of the PEG-BCT-100 (not including hydroxyurea or thioguanine)
2. Any toxic effects (except hair loss) of the prior therapy have not been resolved to Grade 1 or less according to National Cancer Institute Common Terminology Criteria for Adverse Events
3. Total bilirubin \> 1.5 x Upper Limit of Normal (ULN) not related to haemolysis or Gilbert's disease, and ratio of concentrations of aspartate transaminase and alanine transaminase (AST/ALT) \> 5 x ULN
4. Creatinine \> 2 x ULN or estimated glomerular filtration rate using Modification of Diet in Renal Disease formula \< 60 ml/min/1.73 m2
5. Second active malignancy within the past year except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast
6. Uncontrolled concomitant illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia
7. History of HIV-1 seropositivity
8. Active infection not adequately responding to appropriate therapy
9. Patient is pregnant or lactating
10. Female with childbearing potential who is not willing to use contraceptive methods which, in the opinion of the investigator, are effective and adequate while on study treatment and for 6 months after the last dose of study treatment
11. Male with a female partner with childbearing potential who is not willing to use contraceptive methods which, in the opinion of the investigator, are effective and adequate while on study treatment and for 6 months after the last dose of study treatment
12. Any condition that is unstable or can jeopardize the safety of the patients and their compliance to the study