Chronic Myelogenous Leukemia
Conditions
Interventions
nilotinib will be orally administered with 300 mg twice daily approximately 12 hours apart, at least one hour before meals or at least 2 hours after meals. Nilotinib are taken for 2 years.
Sponsors
Japanese Red Cross Nagoya First Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women aged 18 and over. 2. Patients with an ECOG performance status of 0-2. 3. Patients who have received imatinib treatment at least 18 months and who have achieved MMR, but not achieved CMR. 4. Patient who meets the following criteria for laboratory tests. a.T.Bill < 1.5 X ULN b.AST and ALT < 2.5 X ULN c. Cre 1.5 < 1.5 X ULN d. AMY and Lipase <= 1.5 X ULN e. ALP <= 2.5 X ULN f. Serum K and Mg, P, Ca >= LLN/ >=LLN in the adjuvant treatment before the first dose of nilotinib 5. Patient who gave written informed consent before starting the screening test.
Exclusion criteria
Exclusion criteria: 1. Patients with history of accelerated phase(AP) or blastic crisis(BC)-CML . 2. Patient with history ofT315I point mutation of BCR-ABL. 3. Patient with history of treatment with TKI other than imatinib. 4. Patient who has any cardiac disturbances including the following conditions. a. Complete left bundle branch block b. Congenital long QT syndrome or family history of long QT syndrome c. History or complication of serious ventricular or atrial tachycardia d.Clinically serious resting bradycardia e.QTc>450 msec by electrocardiography f. Use of a ventricular pacemaker g.History of Myocardial infarction within 12 months before start of study h.Other heart disease with clinically significant. 5. Patients have been administered the drug can prolong the QT interval. 6. Patient who has any gastrointestinal disorders or diseases which may affect the absorption of the study drug. 7. Patients who has a history of acute or chronic pancreatitis within one year. 8. Patient who has CNS involvement of leukemic cells 9. Cancer patients with a duplication of activity. 10. Patients with complications such as severe or uncontrolled. 11. Patients with a history of congenital or acquired serious bleeding disorders not associated with leukemia. 12. History of major surgery within 4 weeks before start of study 13. Patients treated with other investigational drugs within 28 days before the start of administration of nilotinib. 14. Patients with a history of non-compliance with medication. 15. Patient who is pregnant or nursing women. 16. Patients who are participating in any other clinical trial include observation trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The cumulative CMR rate by 18 months after the initiation of nilotinib treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| * The cumulative CMR rate by 24 months after the initiation of nilotinib treatment. * Percentage of patients maintaining CMR at 24 month after the initiation of nilotinib treatment. * Overall survival (OS) at 24 months after the initiation of nilotinib treatment. * Relapse-free survival (RFS) at 24 months after the initiation of nilotinib treatment. * Safety of nilotinib. | — |
Countries
Japan
Contacts
Public ContactYukiyasu OZAWA
Japanese Red Cross Nagoya First Hospital Division of Hematology
Outcome results
None listed