Clinical Trials List
Protocol NumberPOLARIS2012-001
Completed
2012-10-01 - 2016-09-12
Phase II
Terminated5
Phase 2 Study of ADI-PEG 20 in Acute Myeloid Leukemia
-
Trial Applicant
-
Sponsor
Polaris Group
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Hui-Jen Tsai Division of Hematology & Oncology
- Ya-Ping Chen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 許瑞峰 Division of Hematology & Oncology
- 張肇松 Division of Hematology & Oncology
- Yi-Chang Liu Division of Hematology & Oncology
- 楊文祺 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
21 Completed
Condition/Disease
急性骨隨性白血病
Objectives
1. The primary objective of this study is:
Response rate, as determined by the International Working group
recommendations
2. The secondary objectives of this study are:
Assessment of safety and tolerability
Time on treatment
Overall survival
Progression free survival (PFS)
Evaluate the response rate and correlate with patient disease burden, and
type of disease.
Determine the pharmacodynamics of ADI-PEG 20
Determine the immunogenicity of ADI-PEG 20
Test Drug
ADI-PEG 20
Active Ingredient
Arginine Deiminase polyethylene glycol
Dosage Form
Injection (IM)
Dosage
11.5±1.0 mg/ml; 3.5ml/vial
Endpoints
1. Primary endpoint(s):
Tumor response rate.
2. Secondary endpoints:
Assessment of safety and tolerability, overall survival, Progression free survival
(PFS) and time on treatment
3. Safety endpoints:
Adverse events, vital signs, laboratory results, and physical examination results.
Tumor response rate.
2. Secondary endpoints:
Assessment of safety and tolerability, overall survival, Progression free survival
(PFS) and time on treatment
3. Safety endpoints:
Adverse events, vital signs, laboratory results, and physical examination results.
Inclution Criteria
1. Main inclusion criteria:
Acute myeloid leukemia (AML) diagnosed by morphologic, histochemical or
cell surface marker criteria.
Patients with AML must have either:
a. Relapsed or refractory leukemia after receiving at least one prior
conventional induction therapy. Those in early first relapse must not have
a matched donor and/or they must not be a candidate for allogeneic stem cell transplantation (usually this would mean the patient is too ill, obese,
has a co-morbid condition or is over the age of 55 years) or
b. Poor-risk AML as defined below:
i. Treatment related AML, except if it is associated with favorable
cytogenetics (e.g., inversion 16, t(16;16), t(8;21), t(15;17), and not a
candidate for stem cell transplantation, or
ii. AML with an antecedent hematologic disease (e.g., MDS,
myelofibrosis, polycythemia vera, etc.), and not a candidate for stem
cell transplantation.
iii. De novo AML ≥ 70 years of age.
iv. AML with unfavorable cytogenetics regardless of age (>18 years), if
patients are not candidates for allogeneic transplantation. Unfavorable
cytogenetics are the following: complex (≥3 abnormalities), -7, -5, 7q-,
5q-, abnormalities of 11q23 excluding t(9;11), t(9;22), inversion 3,
t(3;3), t(6;9).
c. Patients older than 60 years of age who had AML (i.e., > 20% bone marrow
blasts) and no prior therapy for AML
Age ≥ 18 years.
ECOG performance status of 0-2.
Post-menarche Female subjects and male subjects must be asked to use
appropriate contraception for both the male and female for the duration of
the study. Subjects must agree to use two forms of contraception or agree to
refrain from intercourse for the duration of the study. Females must not be
pregnant at the start of the study, and a serum human chorionic gonadotropin
(HCG) pregnancy test must be negative before entry into the study.
Informed consent must be obtained prior to study initiation.
No concurrent investigational drug studies are allowed.
Serum uric acid ≤ 8 mg/dL (with or without medication control).
Creatinine clearance must be ≥ 30 mL/min. This can be calculated using the
Cockcroft-Gault equation: estimated creatinine clearance = [(140 – age) x
weight (in kg)] / serum creatinine (in mg/dl) x 72; for females, multiple resultby 0.85.
Total bilirubin ≤ 2X upper limit of normal.
AST/SGOT and ALT/SGPT ≤ 3X upper limit of normal.
Adequate heart and lung function.
Acute myeloid leukemia (AML) diagnosed by morphologic, histochemical or
cell surface marker criteria.
Patients with AML must have either:
a. Relapsed or refractory leukemia after receiving at least one prior
conventional induction therapy. Those in early first relapse must not have
a matched donor and/or they must not be a candidate for allogeneic stem cell transplantation (usually this would mean the patient is too ill, obese,
has a co-morbid condition or is over the age of 55 years) or
b. Poor-risk AML as defined below:
i. Treatment related AML, except if it is associated with favorable
cytogenetics (e.g., inversion 16, t(16;16), t(8;21), t(15;17), and not a
candidate for stem cell transplantation, or
ii. AML with an antecedent hematologic disease (e.g., MDS,
myelofibrosis, polycythemia vera, etc.), and not a candidate for stem
cell transplantation.
iii. De novo AML ≥ 70 years of age.
iv. AML with unfavorable cytogenetics regardless of age (>18 years), if
patients are not candidates for allogeneic transplantation. Unfavorable
cytogenetics are the following: complex (≥3 abnormalities), -7, -5, 7q-,
5q-, abnormalities of 11q23 excluding t(9;11), t(9;22), inversion 3,
t(3;3), t(6;9).
c. Patients older than 60 years of age who had AML (i.e., > 20% bone marrow
blasts) and no prior therapy for AML
Age ≥ 18 years.
ECOG performance status of 0-2.
Post-menarche Female subjects and male subjects must be asked to use
appropriate contraception for both the male and female for the duration of
the study. Subjects must agree to use two forms of contraception or agree to
refrain from intercourse for the duration of the study. Females must not be
pregnant at the start of the study, and a serum human chorionic gonadotropin
(HCG) pregnancy test must be negative before entry into the study.
Informed consent must be obtained prior to study initiation.
No concurrent investigational drug studies are allowed.
Serum uric acid ≤ 8 mg/dL (with or without medication control).
Creatinine clearance must be ≥ 30 mL/min. This can be calculated using the
Cockcroft-Gault equation: estimated creatinine clearance = [(140 – age) x
weight (in kg)] / serum creatinine (in mg/dl) x 72; for females, multiple resultby 0.85.
Total bilirubin ≤ 2X upper limit of normal.
AST/SGOT and ALT/SGPT ≤ 3X upper limit of normal.
Adequate heart and lung function.
Exclusion Criteria
2. Main exclusion criteria:
Patients with infections requiring intravenous (IV) antibiotic/antiviral therapy
are not eligible for entry onto the study; patients on prophylactic antibiotics
or antivirals are acceptable.
Pregnancy or lactation.
Expected non-compliance.
Uncontrolled intercurrent illness including, but not limited to, ongoing or
active infection, symptomatic congestive heart failure (New York Heart
Association Class III or IV), cardiac arrhythmia, psychiatric illness, social
situations that would limit compliance with study requirements or DIC.
Subjects who have had any anticancer treatment prior to entering the study
and have not recovered to baseline (except alopecia) or ≤ Grade 1 AEs, or
deemed irreversible from the effects of prior cancer therapy. AEs > Grade 1
that are not considered a safety risk by the Sponsor and investigator may be
allowed upon agreement with both.
Subjects with history of another primary cancer, including co-existent second
malignancy, with the exception of: a) curatively resected non-melanoma skin
cancer; b) curatively treated cervical carcinoma in situ; or c) other primary
solid tumor with no known active disease present in the opinion of the
investigator will not affect patient outcome in the setting of current diagnosis.
Subjects who had been treated with ADI-PEG 20 previously.
History of seizure disorder not related to underlying cancer.
Known HIV positivity (testing not required).
CNS leukemia or extramedullary leukemia.
Allergy to pegylated compounds
Patients with infections requiring intravenous (IV) antibiotic/antiviral therapy
are not eligible for entry onto the study; patients on prophylactic antibiotics
or antivirals are acceptable.
Pregnancy or lactation.
Expected non-compliance.
Uncontrolled intercurrent illness including, but not limited to, ongoing or
active infection, symptomatic congestive heart failure (New York Heart
Association Class III or IV), cardiac arrhythmia, psychiatric illness, social
situations that would limit compliance with study requirements or DIC.
Subjects who have had any anticancer treatment prior to entering the study
and have not recovered to baseline (except alopecia) or ≤ Grade 1 AEs, or
deemed irreversible from the effects of prior cancer therapy. AEs > Grade 1
that are not considered a safety risk by the Sponsor and investigator may be
allowed upon agreement with both.
Subjects with history of another primary cancer, including co-existent second
malignancy, with the exception of: a) curatively resected non-melanoma skin
cancer; b) curatively treated cervical carcinoma in situ; or c) other primary
solid tumor with no known active disease present in the opinion of the
investigator will not affect patient outcome in the setting of current diagnosis.
Subjects who had been treated with ADI-PEG 20 previously.
History of seizure disorder not related to underlying cancer.
Known HIV positivity (testing not required).
CNS leukemia or extramedullary leukemia.
Allergy to pegylated compounds
The Estimated Number of Participants
-
Taiwan
33 participants
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Global
43 participants
