Chronic Myelogenous Leukemia
Conditions
Interventions
In accordance with the approved dosage and administration of nilotinib for patients with CML-CP resistant to imatinib, 2 X 200 mg capsules of nilotinib (400 mg) are taken twice daily (800 mg/day) for
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. 2) Patients who have never had blast crisis or accelerated CML. 3) Patients who have received imatinib for 18 months or longer. 4) Patients taking a regular dose of imatinib between 300 and 400 mg/day during the previous 6 months. 5) Patients in whom MMR was demonstrated by an examination conducted within 3 months prior to registration and who have not reached CMR. 6) Age 16 years or older. 7) Patients with an ECOG performance status of 0-2. 8) Written informed consent from the subject.
Exclusion criteria
Exclusion criteria: 1) Patients previously treated by tyrosine kinase inhibitors other than imatinib. 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
Secondary
| Measure | Time frame |
|---|---|
| * Percentage of patients maintaining CMR for more than 1 year by 24 month after the initiation of nilotinib treatment. * Cumulative CMR rate by 12 months after the initiation of nilotinib treatment. * Overall survival (OS), progression-free survival (PFS) and event-free survival (EFS) at 12 and 24 months after the initiation of nilotinib treatment. * Correlation between the time to achieve CCyR or MMR and the cumulative CMR rate by 24 months after the initiation of nilotinib treatment or the percentage of patients maintaining CMR for more than 1 year. * Correlation between the trough blood concentration of imatinib/nilotinib and the CMR rate or the percentage of patients maintaining CMR for more than 1 year. * Factors that predict achieving CMR. * Demographic factors that distinguish patients who achieved CMR from those who did not. * Safety of nilotinib. | — |
Primary
| Measure | Time frame |
|---|---|
| The cumulative CMR rate by 24 months after the initiation of nilotinib treatment | — |
Countries
Japan
Contacts
Public ContactItaru MATSUMURA
Kinki University School of Medicine Division of Hematology, Department of Internal Medicine
Outcome results
None listed