Chronic myeloid leukemia -chronic phase (CML-CP)
Conditions
Interventions
In accordance with the approved dosage, 2 x 50 mg tablets of dasatinib are taken once daily (100 mg/day) for 2 years.
Sponsors
CML stem cell study group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: CML-CP patients that corresponds to all the following criteria 1) CML-CP patients on treatment of imatinib, nilotinib or dasatinib. 2) Patients without blast phase or accelerated phase CML. 3) No extramedullary leukemia except hepatomegalia and splenoma. 4) Patients with Ph+ or wild type in myeloid cytogenetics. 5) Patients for CMR within 3 months before registration (Amp-CML: <5 copies/assay, PCR: <=0.0032%) 6) Age >=16 years 7) ECOG performance status of 0-2 8) Laboratory test as follows 1. Albumin: >= LLN 2. Total bilirubin: <= 3xULN 3. AST & ALT: <= 3xULN 4. Creatinine: <= 3xULN 5. Potassium: >= LLN 6. Magnesium: >= LLN 9) No pleural effusion in chest X-ray. 10) SpO2: >=94% 11) Patient in compliance with the prescribed visit schedule. 12) Written informed consent from the patient.
Exclusion criteria
Exclusion criteria: 1) Patients who attend other clinical trial. 2) BCR-ABL point mutation (T315I, F317L, V299L) 3) QTc interval prolongation (>450msec) 4) Patient who has clear pleural effusion 5) Patients who have the following cardiovascular dysfunction 1. Impossible to measure QT interval in ECG 2. Complete left bundle branch block 3. Internal pacemaker 4. Congenital long QT syndrome or family history 5. Tachycardia 6. Bradycardia (<50bpm) 7. Myocardial infarction within 6 months 8. Angina pectoris within 3 months 9. Congestive heart failure within 3 months 10. Patient who have the complications of cardiovascular disorder 6) Active double cancer 7) Pregnant or breastfeeding woman 8) Patient who have complications with serious or poor control 9) Mental disorder 10) Cognitive dysfunction 11) Patient who judges the investigator to have difficulty in participation in study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The CMR maintenance rate at 1 year after a stop of dasatinib administration in patient who have maintained CMR for 2 years in treatment of TKIs. | — |
Secondary
| Measure | Time frame |
|---|---|
| * The CMR maintenance rate at 2 and 3 years ,and relapse free survival (RFS), event free survival (EFS) , progression free survival (PFS) and overall survival (OS) at 1, 2 and 3 years after a stop of dasatinib administration in patient who have maintained CMR for 2 years after a start of clinical study. *The 2 year CMR maintenance rate of patients at 24 months after the start of study. * The relationship between the time to CMR or MMR achievement and CMR maintenance rate at 1, 2 and 3 year after the stop of administration. * The search for predictive factor of a stop of dasatinib administration. * The relationship between the CMR maintenance rate and the following factors. - age, sex, Sokal score - treatment duration of TKIs - Total duration of BCR-ABL negative conversion to pre-registration. - LGL incidence - total treatment period and total dose of dasatinib * CMR achievement rate after re-administration in recurrent case after stop of dasatinib administration. * Safety | — |
Countries
Japan
Contacts
Public ContactToshihiro Miyamoto
Graduate School of Medical Sciences, Kyushu University Department of Medicine and Biosystemic Science
Outcome results
None listed