None listed
Conditions
Interventions
Drug : The starting dose of ponatinib will be 45 mg taken orally once daily. Patients will take the prescribed number of tablets with water, with or without food, at approximately the same time each
complete instructions will be provided with the Study Reference Manual. Patients who forget to take their dose more than 6 hours after it is due should not make up the missed dose. Any missing doses
Sponsors
ARIAD Pharmaceuticals
Pharmanet Korea
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| MMR rate at 5 years;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-ABLIS);Complete cytogenetic response (CCyR) rate ;progression-free survival and overall survival | — |
Countries
Korea, Republic of
Contacts
Public ContactSa Hee Park
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed