Research on the blood concentration of ponatinib and treatment outcome in patients with chronic phase chronic myelogenous leukemia (CP-CML)
- Conditions
- chronic phase chronic myelogenous leukemia (CP-CML)
- Registration Number
- JPRN-UMIN000035692
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 26
1)Diagnosed as CP-CML using standard hematopathological and cytogenetic criteria.
2)Patients with CP-CML resistant or intolerant to previous medication such as;
1CCyR was achieved with prior TKI treatment, but later showed resistance.
2CCyR 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
1Lipase <= 106 U/L (2xULN)
2Amylase <= 264 U/L (2xULN)
6)Written consent is obtained
7)Can visit the study site on specified visit schedule
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method