Chronic Myelogenous Leukemia
Conditions
Interventions
2 capsules (150 mg) of nilotinib will be taken twice daily (600 mg/day) for 2 years.
Sponsors
Cooperative study among the East Japan CML Study Group, Shimousa Hematology Study Group, Leukemia Study Group in Mie, Niigata CML Study Group and the NPO Tohoku Hematology Expert Meeting
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 in whom MMR was demonstrated by an examination conducted within 1 year prior to registration and who have not reached CMR. 4) Age 16 years or older. 5) Patients with an ECOG performance status of 0-2. 6) Patients who have the following clinical laboratory values: i) Serum bilirubin (T.Bil) <=1.5 X the upper limit of normal for the clinical study site (ULN) ii) AST and ALT <=2.5 X ULN iii) Alkaline phosphatase (ALP) <=2.5 X ULN iv) Serum creatinine (s-Cr) <=3.0 X ULN v) Serum lipase <=1.5 X ULN vi) Potassium (K) >=the lower limit of normal at the clinical study site (LLN) vii) Magnesium (Mg) >=LLN viii) Phosphate (IP) >=LLN ix) Total calcium (Ca) (after adjustment by serum albumin) >=LLN x) QTc <450 msec on ECG 7) Patients who can attend the clinical study site in accordance with the pre-defined schedule. 8) Written informed consent from the subject (from the legal representative if the subject is under 20 years old).
Exclusion criteria
Exclusion criteria: 1) Patients previously treated by tyrosine kinase inhibitors other than imatinib. 2) Patients who are participating in any other clinical trial. 3) Patients with the T315I point mutation of BCR-ABL. 4) Patients with one of the following indicators of cardiovascular dysfunction. i) The QT interval cannot be measured on the ECG ii) Complete left bundle branch block iii) Ventricular pacemaker iv) Congenital QT interval prolongation syndrome or a family history of QT interval prolongation syndrome v) History of or current severe ventricular or atrial tachycardia vi) Clinically significant bradycardia at rest (<50 bpm) vii) History of clinically diagnosed myocardial infarction viii) History of unstable angina within 12 months prior to initiation of the study ix) Other clinically significant cardiovascular complications 5) Patients with another primary malignant tumor. 6) Gastrointestinal dysfunction or diseases that could greatly influence absorption of the study medication. 7) Patients with a history of acute or chronic pancreatitis within 1 year prior to participation to the study. 8) Pregnant women or those with suspected pregnancy. Nursing women and those who plan to become pregnant during the study period. 9) Patients with multiple invasive cancers within 5 years prior to initiation of the study. 10) Patients with other serious or uncontrollable complications. 11) Patients with a psychiatric illness or symptoms that make it difficult to participate in the study. 12) Patients with cognitive dysfunction. 13) Other patients whom the investigator considers to be unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CMR rate at 24 months after the initiation of nilotinib treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The rate of patients who have sustained CMR for more than 1 year at 24 months after the initiation of nilotinib treatment. 2) CMR rate at 12 months after the initiation of nilotinib treatment. 3) Overall survival (OS), progression-free survival (PFS) and event-free survival (EFS) at 12 and 24 months after the initiation of nilotinib treatment. 4) Relationship between the time needed to reach CCyR and MMR, the CMR rate at 24 months after the initiation of nilotinib, and the rate of patients sustaining CMR for more than 1 year. | — |
Countries
Japan
Contacts
Public ContactNaoto TAKAHASHI
Akita University School of Medicine Department of Hematology, Nephrology and Rheumatology
Outcome results
None listed