Chronic Myelogenenous Leukemia
Conditions
Interventions
Nilotinib will be administered at a dose of 300 mg (2 X 150 mg capsules) twice daily (600 mg/day) for 2 years. However, if a patient was taking 800 mg/day of nilotinib prior to initiation of the stud
Sponsors
Cooperative study between the West Japan Hematology Study Group and the Clinical Research Support Center Kyushu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with CML-CP under treatment with imatinib or nilotinib. 2) Patients who have never had blast crisis or accelerated CML. 3) Patients with confirmed CMR based on the result of an assay conducted within 3 months prior to registration. 4) Age 16 years or older. 5) Patients with an ECOG performance status of 0-2. 6) Written informed consent from the subject.
Exclusion criteria
Exclusion criteria: 1) Patients previously treated by tyrosine kinase inhibitors other than imatinib or nilotinib. 2) Patients confirmed to have the T315I point mutation of BCR-ABL. 3) Patients with a history of hematopoietic stem cell transplantation. 4) Patients with cardiovascular dysfunction. 5) Pregnant women or those with suspected pregnancy. Nursing women and those who plan to become pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CMR rate at 1 year after discontinuation of nilotinib treatment in patients who have maintained CMR for 2 years after initiation of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| * CMR maintenance rate at 2 and 3 years after the discontinuation of nilotinib treatment and relapse-free survival (RFS), event-free survival (EFS), progression-free survival (PFS), and overall survival (OS) at 1, 2, and 3 years after discontinuation in patients who maintain CMR for 2 years after initiation of the study. * Percentage of patients who have maintained CMR for 2 years at 24 months after initiation of the study. * Correlation between the time to CMR or MMR and the CMR maintenance rate at 1, 2, and 3 years after discontinuation of treatment. * Correlation between the CMR duration prior to the discontinuation of nilotinib treatment and the CMR rate at 1, 2, and 3 years after discontinuation. * Investigation of predictors of the discontinuation of nilotinib treatment. * To investigate patient demographic and pharmacokinetic factors that explain differences between patients with and without relapse after discontinuation of nilotinib. * CMR rate after re-administration of nilotinib in patients with relapse following the discontinuation of nilotinib treatment. * Safety of nilotinib | — |
Countries
Japan
Contacts
Public ContactItaru MATSUMURA
Kinki University School of Medicine Division of Hematology, Department of Internal Medicine
Outcome results
None listed