Clinical Trials List
Protocol NumberAP24534-12-301
NCT Number(ClinicalTrials.gov Identfier)NCT01650805
2013-01-15 - 2018-01-30
Phase III
Terminated2
Study ended1
ICD-10C92.10
Chronic myeloid leukemia, BCR/ABL-positive, not having achieved remission
A Phase 3 Randomized, Open-Label Study of Ponatinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
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Trial Applicant
台灣法瑪特股份有限公司
-
Sponsor
ARIAD Pharmaceuticals, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Ching Yun Hsieh Division of Hematology & Oncology
- Yu-Min Liao Division of Hematology & Oncology
- Li-Yuan Bai Division of Hematology & Oncology
Co-Principal Investigator
- 林建廷 Division of Hematology & Oncology
- MING YAO Division of Hematology & Oncology
- Wen-Chien Chou Division of Hematology & Oncology
- 徐思淳 Division of Hematology & Oncology
- - - Division of Hematology & Oncology
- Shang-Ju Wu Division of Hematology & Oncology
- 李啟誠 Division of Hematology & Oncology
- - - Division of Hematology & Oncology
- HSIN-AN HOU Division of Hematology & Oncology
- 蔡偉 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Chronic Myeloid Leukemia
Objectives
Primary
To compare the efficacy of ponatinib with imatinib as measured by major
molecular response (MMR) rate at 12 months (1 month or cycle = 28 days)
Key Secondary
To compare, according to treatment with ponatinib versus imatinib, MMR
rate at 5 years
To compare the proportion of patients achieving a ratio of <10% BCR-ABL
to ABL transcript levels at 3 months, as measured by the international scale
(<10% BCR-ABL
IS), in patients administered ponatinib versus those
administered imatinib
To compare, according to treatment with ponatinib versus imatinib, the
complete cytogenetic response (CCyR) rate at 12 months
To compare, according to treatment with ponatinib versus imatinib,
progression-free survival and overall survival
Test Drug
AP24534
Active Ingredient
Ponatinib
Dosage Form
tablet
Dosage
15
45
45
Endpoints
Primary Endpoint
MMR rate at 12 months (1 month or cycle = 28 days)
Key Secondary Endpoints
MMR rate at 5 years
<10% BCR-ABL
IS rate at 3 months
CCyR rate at 12 months
Progression-free survival
Overall survival
MMR rate at 12 months (1 month or cycle = 28 days)
Key Secondary Endpoints
MMR rate at 5 years
<10% BCR-ABL
IS rate at 3 months
CCyR rate at 12 months
Progression-free survival
Overall survival
Inclution Criteria
1. Male or female patients ≥18 years old
2. CP-CML within 6 months of diagnosis
a. CP-CML will be defined by
i <15% blasts in bone marrow
ii <30% blasts plus promyelocytes in bone marrow
iii <20% basophils in peripheral blood
iv ≥100 × 109
/L platelets (≥100,000/mm3
)
v No evidence of extramedullary disease except
hepatosplenomegaly
vi No prior diagnosis of accelerated phase (AP) or blast phase
(BP) CML
3. Cytogenetic assessment must demonstrate the BCR-ABL fusion by presence
of the t(9;22) Philadelphia chromosome
a. Variant translocations are only allowed provided they are assessable
for cytogenetic response utilizing conventional cytogenetic
techniques
b. Conventional chromosome banding must be performed
c. A minimum of 20 metaphases must be assessable at entry
4. ECOG Performance Status of 0, 1, or 2
5. Adequate hepatic function as defined by the following criteria:
a. Total serum bilirubin ≤1.5 x upper limit of normal (ULN), unless
due to Gilbert’s syndrome
b. Alanine aminotransferase (ALT) ≤2.5 × ULN
c. Aspartate aminotransferase (AST) ≤2.5 × ULN
6. Adequate renal function as defined by the following criterion:
a. Serum creatinine <1.5 × ULN
7. Adequate pancreatic function as defined by the following criterion:
a. Serum lipase and amylase ≤1.5 × ULN
8. For females of childbearing potential, a negative pregnancy test must be
documented prior to randomization
9. Female and male patients who are of childbearing potential must agree to use an effective form of contraception with their sexual partners from
randomization through 30 days after the end of treatment
10. Provide written informed consent
11. Willingness and ability to comply with scheduled visits and study procedures
2. CP-CML within 6 months of diagnosis
a. CP-CML will be defined by
i <15% blasts in bone marrow
ii <30% blasts plus promyelocytes in bone marrow
iii <20% basophils in peripheral blood
iv ≥100 × 109
/L platelets (≥100,000/mm3
)
v No evidence of extramedullary disease except
hepatosplenomegaly
vi No prior diagnosis of accelerated phase (AP) or blast phase
(BP) CML
3. Cytogenetic assessment must demonstrate the BCR-ABL fusion by presence
of the t(9;22) Philadelphia chromosome
a. Variant translocations are only allowed provided they are assessable
for cytogenetic response utilizing conventional cytogenetic
techniques
b. Conventional chromosome banding must be performed
c. A minimum of 20 metaphases must be assessable at entry
4. ECOG Performance Status of 0, 1, or 2
5. Adequate hepatic function as defined by the following criteria:
a. Total serum bilirubin ≤1.5 x upper limit of normal (ULN), unless
due to Gilbert’s syndrome
b. Alanine aminotransferase (ALT) ≤2.5 × ULN
c. Aspartate aminotransferase (AST) ≤2.5 × ULN
6. Adequate renal function as defined by the following criterion:
a. Serum creatinine <1.5 × ULN
7. Adequate pancreatic function as defined by the following criterion:
a. Serum lipase and amylase ≤1.5 × ULN
8. For females of childbearing potential, a negative pregnancy test must be
documented prior to randomization
9. Female and male patients who are of childbearing potential must agree to use an effective form of contraception with their sexual partners from
randomization through 30 days after the end of treatment
10. Provide written informed consent
11. Willingness and ability to comply with scheduled visits and study procedures
Exclusion Criteria
1. Received prior imatinib therapy
2. Received prior dasatinib therapy
3. Received prior nilotinib therapy
4. Received, for CML, any other systemic anticancer therapy, experimental
therapy, or radiation therapy with the exception of anagrelide or hydroxyurea
5. Major surgery within 28 days prior to initiating therapy
6. History of bleeding disorder unrelated to CML
7. History of acute pancreatitis within 1 year of study or history of chronic
pancreatitis
8. History of alcohol abuse
9. Have uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL)
10. Significant uncontrolled or active cardiovascular disease, specifically
including, but not restricted to:
a. Myocardial infarction, unstable angina and/or congestive heart
failure within 3 months prior to randomization
b. History of clinically significant (as determined by the treating
physician) atrial arrhythmia; or any ventricular arrhythmia
11. Uncontrolled hypertension (diastolic blood pressure >100 mm Hg; systolic
>150 mm Hg)
12. Taking medications that are known to be associated with Torsades de Pointes
(Appendix A)
13. Ongoing or active infection. The requirement for intravenous (IV) antibiotics
is considered active infection
14. Known history of human immunodeficiency virus (HIV). Testing is not
required in the absence of history
15. Pregnant or breastfeeding
16. Malabsorption syndrome or other gastrointestinal illness that could affect oral
absorption of study drugs
17. Diagnosed with or received anticancer therapy for another primary
malignancy within 3 years prior to entry (except for non-melanoma skin
cancer or cervical cancer in situ)
18. Any condition or illness that, in the opinion of the Investigator, would
compromise patient safety or interfere with the evaluation of the drug
2. Received prior dasatinib therapy
3. Received prior nilotinib therapy
4. Received, for CML, any other systemic anticancer therapy, experimental
therapy, or radiation therapy with the exception of anagrelide or hydroxyurea
5. Major surgery within 28 days prior to initiating therapy
6. History of bleeding disorder unrelated to CML
7. History of acute pancreatitis within 1 year of study or history of chronic
pancreatitis
8. History of alcohol abuse
9. Have uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL)
10. Significant uncontrolled or active cardiovascular disease, specifically
including, but not restricted to:
a. Myocardial infarction, unstable angina and/or congestive heart
failure within 3 months prior to randomization
b. History of clinically significant (as determined by the treating
physician) atrial arrhythmia; or any ventricular arrhythmia
11. Uncontrolled hypertension (diastolic blood pressure >100 mm Hg; systolic
>150 mm Hg)
12. Taking medications that are known to be associated with Torsades de Pointes
(Appendix A)
13. Ongoing or active infection. The requirement for intravenous (IV) antibiotics
is considered active infection
14. Known history of human immunodeficiency virus (HIV). Testing is not
required in the absence of history
15. Pregnant or breastfeeding
16. Malabsorption syndrome or other gastrointestinal illness that could affect oral
absorption of study drugs
17. Diagnosed with or received anticancer therapy for another primary
malignancy within 3 years prior to entry (except for non-melanoma skin
cancer or cervical cancer in situ)
18. Any condition or illness that, in the opinion of the Investigator, would
compromise patient safety or interfere with the evaluation of the drug
The Estimated Number of Participants
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Taiwan
15 participants
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Global
528 participants
