chronic myeloid leukemia
Conditions
Interventions
Patients will take 100 mg of dasatinib once daily at the same time each day. The daily dosage may be increased up to 140 mg according to the patient'
Sponsors
Kansai CML-Clinical Study Group
Kansai CML-Clinical Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) De novo chronic myeloid leukemia patients in chronic phase (Who meet all the conditions listed below) Less than 15% myeloblasts in the bone marrow Less than 30% myeloblasts plus promyelocytes in the bone marrow Less than 20% basophils in the peripheral blood Platelet counts of 100,000 / mm3 or more Absence of extramedullary disease except for hepatosplenomegaly Cells carrying Ph chromosome or its variant confirmed by bone marrow cytogenetics test 2) Patients have an ECOG performance status of 0 to 2 3) Patients with adequate hepatic, renal and pulmonary function AST and ALT less than 5 times the institutional upper limit, with total bilirubin less than 3 times the institutional upper limit Serum creatinine level less than 3 times the institutional upper limit PaO2 greater than 60 mmHg by arterial blood gas analysis, or SpO2 not below than 93% by pulse oximeter, while breathing room air 4) Patients have received no previous treatment for CML except for hydroxyurea 5) Signed written informed consent
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from this study 1) Presence of any other active neoplasm 2) Pregnant and lactating woman 3) Whom the investigator considered inappropriate to this study 4) Presence of apparent pleural effusion 5) Patients with complication or history of serious or poor-controlled cardiovascular disorders as below Cardiac infarction within 6 months Angina pectoris within 3 months Congestive heart failure within 3 months Suspicion of a congenital long QT syndrome QTc interval prolongation (adjusted according to Fridericia's formula) on the electrocardiogram exceed 450 msec at baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Examine the relationship between occurrence of pleural effusion caused by dasatinib medication and levels of angiopoietin-2 in plasma. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Examine the relationship between dasatinib medication and occurrence of pleural effusion by vascular endothelial function related parameters and by immunological parameters. 2) Examine the relationship between dasatinib medication and thrombocytopenia by vascular endothelial function related parameters and by immunological parameters. | — |
Countries
Japan
Contacts
Public ContactTomoki Ito
Kansai Medical University First Department of Internal Medicine
Outcome results
None listed