chronic myeloid leukemia chronic phase
Conditions
Interventions
None listed
Sponsors
Department of Hematology and Oncology, Mie University Graduate School of Medicine
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) a) Less than 15% myeloblasts in the bone marrow b) Less than 30% myeloblasts plus promyelocytes in the bone marrow c) Less than 20% basophils in the peripheral blood d) Platelet counts of 100,000 / mm3 or more e) Absence of extramedullary disease except for hepatosplenomegaly f) 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 a) AST and ALT less than 5 times the institutional upper limit, with total bilirubin less than 3 times the institutional upper limit b) Serum creatinine level less than 3 times the institutional upper limit c) PaO2 greater than 60 mmHg by arterial blood gas analysis, or SpO2 not below than 93% by pulse oximeter, while breathing room air 4) Signed written informed consent
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria are excluded from this study 1) Who have received therapy with anticancer agents other than hydroxycarbamide within the most recent one month 2) Presence of any other active neoplasm 3) Pregnant and lactating woman 4) Presence of apparent pleural effusion 5) Patients with complication or history of serious or poor-controlled cardiovascular disorders as below a) Cardiac infarction within 6 months b) Angina pectoris within 3 months c) Congestive heart failure within 3 months 6) QTc interval prolongation (adjusted according to Fridericia's formula) on the electrocardiogram exceed 450 msec at baseline 7) Patients with previous history or complication that the investigator considered inappropriate to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessing medication adherence till 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Assessment of Medication Possession Ratio (MPR) 2) Assessment of pharmacokinetics of dasatinib at day 14 3) Examine the relationship between blood concentration of dasatinib at day 28 and adverse events 4) Assessment of the therapeutic effect at 1, 3, 6, and 12 months 5) Quantitative analysis of chimeric bcr/abl mRNAs at 3 months 6) Adverse events assessment | — |
Countries
Japan
Contacts
Public ContactFumihiko Monma
Mie University Graduate School of Medicine Department of Hematology and Oncology
Outcome results
None listed