chronic phase chronic myelogenous leukemia (CP-CML)
Conditions
Interventions
None listed
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed as CP-CML using standard hematopathological and cytogenetic criteria. 2) Patients with CP-CML resistant or intolerant to previous medication such as; 1 CCyR was achieved with prior TKI treatment, but later showed resistance. 2 CCyR was achieved but not reached MMR, and became intolerance within 12 months after the start of prior TKI treatment. 3) Planned to be treated with ponatinib in clinical practice 4) Aged >= 20 years at informed consent 5) Pancreatic functions are within the following range 1 Lipase <= 106 U/L (2xULN) 2 Amylase <= 264 U/L (2xULN) 6) Written consent is obtained 7) Can visit the study site on specified visit schedule
Exclusion criteria
Exclusion criteria: 1) Have received ponatinib 2) Have an uncontrollable or active heart disease, or history of cardiovascular disease within 2 years such as the following but not limited to: a. Myocardial infarction (MI) b. Unstable angina pectoris c. Congestive heart failure (CHF) d. Atrial arrhythmia e. Ventricular arrhythmia f. Cerebrovascular disorder or transient ischemic attack (TIA) g. Peripheral arterial occlusive disease requiring vascular regeneration h. Venous thromboembolism including deep venous thrombosis and pulmonary embolism 3) Have hepatic dysfunction which meet the following 3 criteria simultaneously at the screening point: a. ALT(GPT) >= 126 U/L (male) / 69 U/L (female), or AST(GOT) >= 90 U/L b. T-Bil > 3.0 mg/dl c. ALP < 644 U/L 4) Have a history of pancreatitis within a year prior to screening 5) Have a history of alcoholic abuse 6) Have hypertriglyceridemia (fasting triglyceride level > 450 mg/dl) 7) Have hypertension which is untreated or uncontrollable with antihypertensive agents 8) Have uncontrollable diabetes 9) ABI (ankle-brachial index) <= 0.9 at the screening point 10) Women who are pregnant, might be pregnant or are breastfeeding 11) Men who plan to have a child 12) Determined to be inappropriate for the conduct of this research by attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Blood concentration of ponatinib for 48 wks in MMR achievement group 2)Blood concentration of ponatinib for 48 wks in MMR non-achievement group | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Blood concentration of ponatinib in group achieving MR4.0 by each time point of 12, 24, 36, and 48 wks 2)Blood concentration of ponatinib in group not achieving MR4.0 by each time point of 12, 24, 36, and 48 wks 3)Blood concentration of ponatinib in group achieving MR4.5 by each time point of 12, 24, 36, and 48 wks 4)blood concentration of ponatinib in group not achieving MR4.5 by each time point of 12, 24, 36, and 48 wks 5)Blood concentration of ponatinib for adverse drug reactions occurred at an incidence of 20% or higher | — |
Countries
Japan
Outcome results
None listed