chronic-phase chronic myeloid leukemia
Conditions
Interventions
Once-daily oral administration of dasatinib will be started at the dose of 20 mg. The treatment effect will be evaluated according to the European LeukemiaNet recommendations (ELN2013) at 3, 6, 9 and
Sponsors
NPO Epidemiological and Clinical Research Information Network (ECRIN)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Newly diagnosed chronic-phase chronic myeloid leukemia (CP-CML). The European LeukemiaNet (ELN) will be followed when evaluating the disease stage (Table 1). 2) Patients aged 70 years or older at the time fo enrollment 3) Patients with ECOG performance status of 0 to 2 4) Patients whose primary organ (liver, kidneys and lungs) functions are maintained (each institutional standard values) 5) Patients who have given written informed consent (approval of the guardian will be required in the case the subject is a minor)
Exclusion criteria
Exclusion criteria: 1)Patients with a history of treatment with drugs (imatinib, nilotinib, dasatinib, and interferon) for CML. Patients who have received prior treatment with Hydrea within 4 weeks can be enrolled. 2)Patients with a history of the following significant or uncontrollable cardiovascular disorders or their complications 2.1)Patients with obvious pleural effusion 2.2) Patients with a history of myocardial infarction within 6 months 2.3) Patients with a history of angina pectoris within 3 months 2.4) Patients with a history of congestive cardiac failure within 3 months 2.5) Patients with suspected congenital QT prolongation syndrome 2.6) Patients with QTc interval prolongation by 500 msec or more on 12-lead ECG 3)Patients receiving treatment for malignant disorders other than CML 4)Patients with uncontrollable severe disease history or complications 5)Patients with a history of hypersensitivity to dasatinib 6)Other patients who are deemed to be ineligible for the study by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major molecular response (MMR) achievement rate at 12 months after initiation of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| [1]Deep molecular response (DMR: MR4, MR4.5) achievement rate at 12 months after initiation of treatment [2]Incidences of AEs of all grades or grade 3 or 4 [3]Treatment discontinuation rate due to AEs after 12 months of treatment with the drug [4]Treatment discontinuation rate due to progression of the disease condition or treatment failure (Failure) after 12 months of treatment [5]Association of Sokal score, Hasford score, and EUTOS score with treatment effects [6]Association of BCR-ABL1 halving time with treatment effects at 3 months after initiation of treatment [7]Association of blood concentration of dasatinib with treatment effects and AEs [8]Association of peripheral blood T and NK cell profiles with treatment effects and AEs | — |
Countries
Japan
Contacts
Public ContactKensuke Kojima
Saga University Hematology, Respiratory Medicine and Oncology
Outcome results
None listed