Myelogenous Leukemia, Chronic, Chronic Phase
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
Sponsors
Kanto CML Study Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Newly diagnosed Chronic Myeloid Leukemia in the Chronic Phase * 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. * female patient who there is not intention with an appropriate sterilization, or cannot use it during a study entry period * Patients with complications or a history of severe or uncontrolled cardiovascular failure following have a Myocardial infarction within 6 months have an Angina within 3 months have a Congestive heart failure within 3 months have a QTc interval of more than 450msec at baseline * A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR | by 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Major Molecular Response(MMR) rate measured by RQ-PCR | by 1 months, then every 6 months for 2 years |
| Complete Cytogenetic Response (CCyR) rate | by 6,12 months |
| Progression free survival (PFS) | Participants were followed for at least 2 years |
| 'Dasatinib affects immunological responses, as measured by flow cytometry | at 3,6,12,24 months |
| The overall probability of maintenance of complete molecular remission after stopping dasatinib as measured by RQ-PCR | by 3,6 months |
| Molecular remission rate measured by PQ-PCR after dasatinib re-challenge in cases of molecular relapse | by 12 months after molecular relapse |
| Complete Molecular Response(CMR) rate measured by RQ-PCR | by 1 months, then every 6 months for 2 years |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Participants were followed for at least 2 years |
Countries
Japan
Outcome results
None listed