Chronic Myelogenou Leukemia-Chronic Phase who have maintained complete molecular remission for at least 2 years.
Conditions
Interventions
Discontinuation of Imatinib in patients with Chronic Myelogenou Leukemia-Chronic Phase who have maintained complete molecular remission for at least 2 years.
Dasatinib treatment to PCR+ patients by PC
Sponsors
Epidemiological and Clinical Research Information Network (ECRIN)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with Chronic Myelogenou Leukemia-Chronic Phase who have maintained complete molecular remission for at least 2 years. 2. ECOG performance status (PS) score 0-2 3. Adequate hepatic, renal and lung function 4. Signed written informed consent
Exclusion criteria
Exclusion criteria: 1. Concurrent malignancy other than CML 2.Women who are pregnant or breastfeeding 3. A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy 4.Subjects with clonal evolution
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Molecular relapse free survival rate after discontinuation of Imatinib at 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Molecular relapse free survival rate after discontinuation of Imatinib at 12,24 months. We assessed previous interferon therapy, sex , sokal risk group and total duration of Imatinib treatment as potential prognostic factors for molecular relapse free survival. CMR rate and time to CMR of PCR+ patients by PCR screening after dasatinib treatment. CMR rate and time to CMR of dasatinib treatment after molecular relapse. | — |
Countries
Japan
Contacts
Public ContactShinya Kimura
DOMEST-Trial Group Division of Hematology, Respiratory Medicine and Oncology, Faculty of Medicine, Saga Univ.
Outcome results
None listed