Chronic Phase Chronic Myeloid Leukemia
Conditions
Interventions
Basic treatment is to take 100 mg of dasatinib, once daily, repeatedly. The maximum daily dose is 140 mg, and the dose can be increased, decreased, or treatment can be stopped at the discretion of inv
= 0.0032% (MR4.5) for 1 year by treatment with dasatinib.
Sponsors
Kanto CML Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with newly diagnosed CML-CP 2) Patients aged 18 years and over 3) Patients with ECOG performance status groups of 0 to 2 4) Patients with adequate functions of major organs (liver, kidney, and lung) (according to reference levels of each institution) 5) Patients who gave a written informed consent to participation in the trial. Minors who gave a written informed consent or one obtained from their legal representatives
Exclusion criteria
Exclusion criteria: 1)Active multiple cancers 2)Pregnant women and lactating mothers 3)Women who do not intend to or cannot use appropriate contraceptives during the registration period 4)Patients with a history or complications of the following severe or uncontrollable symptoms Myocardial infarction within the past 6 months Angina pectoris within the past 3 months Gastrointestinal haemorrhage within the past 3 months Congestive cardiac failure within the past 3 months Having plural effusion Electrocardiogram QTc interval prolonged exceeding 450 msec at the start of treatment (baseline) (Fridericia correction) Present or past history of pulmonary hypertension 5)Patients with a history or complications of diseases judged as inappropriate for study implementation by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients in TFR who show no molecular relapse and do not need resumption of dasatinib treatment 12 months after discontinuation of dasatinib treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients in TFR 24, 36, and 48 months after discontinuation of dasatinib treatment. Molecular relapse free survival 12 months after discontinuation of dasatinib treatment Overall survival (OS) including all causes of death 12, 24, 36, and 48 months after discontinuation of dasatinib treatment Dasatinib doses and time to MR4.5 Event free survival (EFS) during dasatinib treatment period. Frequency and degree of TKI withdrawal syndrome after discontinuation of dasatinib treatment. | — |
Countries
Japan
Contacts
Public ContactCHIKASHI YOSHIDA
National Hospital Organization Mito Medical Center Department of Hematology
Outcome results
None listed