To evaluate the efficacy of PEG-BCT-100 in patients with relapsed or refractory acute myeloid
leukemia (AML) in terms of remission rate.
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Full eligibility criteria for NCT02899286
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Adult patients ≥18 year-old at the time of informed consent
Documented relapsed or refractory AML after at least two standard chemotherapy regimen or in whom the treating physicians considered unfit for further chemotherapy treatment
The Eastern Cooperative Oncology Group (ECOG) performance status equal or less than 2
Patients from whom valid consent is obtained
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)
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
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
Creatinine > 2 x ULN or estimated glomerular filtration rate using Modification of Diet in Renal Disease formula < 60 ml/min/1.73 m2
Second active malignancy within the past year except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast
Uncontrolled concomitant illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia
History of HIV-1 seropositivity
Active infection not adequately responding to appropriate therapy
Patient is pregnant or lactating
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
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
Any condition that is unstable or can jeopardize the safety of the patients and their compliance to the study
All locations for NCT02899286
Hong Kong (1)
The University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong
View full eligibility
Tris trial is registered with FDA with number: NCT02899286. The sponsor of the trial is Bio-Cancer Treatment International Limited and it is looking for 25 volunteers for the current phase.
Official trial title: A Phase II Open-label Study of the Efficacy and Safety of Recombinant Human Arginase 1 (PEG-BCT-100) in Patients With Relapsed or Refractory Acute Myeloid Leukemia
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