chronic myeloid leukemia
Conditions
Interventions
Oral bosutinib is introduced at 200mg QD for the initial dose. If all AEs are more than grade 2, the dose is gradually titrated by 100mg/day every two weeks. If any AEs are less than grade 3, the admi
Sponsors
Division of Hematology, Respiratory diseases and Oncology, Faculty of Medicine, Saga University
Faculty of Medicine, Akita University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients of major BCR-ABL-positive CML-CP 2)Patients aged 18 or above at the time of pre-enrollment 3)Patients who exhibited resistance or intolerance to 1 or 2 other TKI 4)Patients with ECOG performance status 0-2 5)Patients whose function of the principal organs (liver, kidneys lungs) are maintained according to criteria by each institution 6)Patients whose written consent was obtained (the consent of parents or guardians required in the case of minors)
Exclusion criteria
Exclusion criteria: 1)Patients who have history of taking anti-cancer drugs other than hydroxyurea for CML 2)Patients who are newly diagnosed CML 3)Patients who have progress to AP or BP 4)Patients with severe or uncontrollable complications 5)Patients with complications of inflammatory bowel disease 6)Pregnant and breastfeeding women, patients who wish to get pregnant within 12 months 7)Patients who are participating in another clinical trial 8)Patients with known T315I or V299L mutation 9)Concomitant medications known to be strong inducers or inhibitors of P450 isoenzyme CYP3A4 10)Known HIV and/or active viral hepatitis (hepatitis B or C) 11)Impaired cardiac function, including any of the following: a. History of or presence of complete left bundle branch block, right bundle branch block plus left anterior hemiblock, bifascicular block in screening ECG b. ST depression of >1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads in screening ECG c. Congenital long QT syndrome d. QTc > 450 msec in the screening ECG e. QT-prolonging concomitant medication f. History of or presence of significant ventricular or atrial tachyarrhythmias in screening ECG g. Myocardial infarction within 6 months prior to inclusion h. Unstable angina diagnosed or treated during the past 12 months i. uncontrolled hypertension, history of labile hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bosutinib treatment drop-out rate due to AEs by 12 months after initiation of bosutinib | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Rate of treatment interruptions 2.Mean bosutinib doses at 12 months after initiation of bosutinib 3.Administration period of bosutinib and its median dose intensity/relative dose intensity up to 12 months after initiation of bosutinib 4.Cumulative complete cytogenetic response (CCyR) maintenance rate at 6 and 12 months after initiation of bosutinib 5.Cumulative major molecular response (MMR) rate and cumulative deep molecular response (DMR rate) at 3, 6, 9 and 12 months after initiation of bosutinib 6.Incidence of all grades or grade 3 or 4 adverse events (AE) | — |
Countries
Japan
Contacts
Public ContactShinya Kimura
Faculty of Medicine, Saga University Hematology, Respiratory Medicine and Oncology
Outcome results
None listed