Chronic Myeloid Leukemia
Conditions
Brief summary
The purpose of this study is to assess whether dasatinib can be discontinued without occurrence of molecular relapse in patients with chronic myeloid leukemia in chronic phase in complete molecular remission (CMR) while on dasatinib.
Interventions
DRUGDasatinib
100mg QD
Sponsors
Epidemiological and Clinical Research Information Network
Shimousa Hematology Study Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic Myeloid Leukemia in the Chronic Phase. * Patients with BCR-ABL-negative checks. * 15 years old over. * ECOG performance status (PS) score 0-2. * Adequate organ function (hepatic, renal and lung). * Signed written informed consent.
Exclusion criteria
* A case with the double cancer of the activity. * Women who are pregnant or breastfeeding. * Patients with complications or a history of severe. * Patients with mutation of T315I、F317L、V299L. * Patients with additional chromosome abnormalities. * The case of Pleural effusion with poor control. * Patients with a history of hematopoietic stem cell transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The overall probability of maintenance of complete molecular remission at 12 months after stopping dasatinib. | at 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Rate of complete molecular remission that will be sustained after dasatinib rechallenge. | at 12 months |
Countries
Japan
Contacts
Primary ContactKoiti Inokuchi, MD,PhD
Outcome results
None listed