Newly diagnosed Chronic Myelogenous Leukemia in chronic phase
Conditions
Interventions
Nilotinib will be administered twice daily at a dose of 300 mg (600 mg/day) .
Sponsors
Hokkaido University Hospital, Department of Hematology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient who has the Philadelphia chromosome or Major bcr-abl transcript at the first visit. 2) Patient who has not experienced a blast or accelerated phase of CML before treatment with Nilotinib. 3) Patient who has never received TKI tretment. 4) Patient with the ECOG performance status of 0, 1 or 2. 6) Patient who meets the following criteria for laboratory tests. (1) T.Bill < 1.5 X ULN (2) AST and ALT < 2.5 X ULN (3) ALP < 2.5 X ULN (4) Cre 1.5 < 1.5 X ULN (5) AMY and Lipase < 1.5 X ULN (6) K > LLN (7) Mg > LLN (8) IP > LLN (9) Corrected Ca > LLN (10) LVEF>45% or LLN by echocardiography (11) QTc<450 msec by electrocardiography 6) Patient from whom an informed consent for the clinical study has been obtained.
Exclusion criteria
Exclusion criteria: 1) Patient who exhibits the T315I BCR-ABL mutation. 2) Patient who is pregnant or breastfeeding. 3) Patient does not agree to use contraceptive methods to prevent pregnancy. 4) Patient who has any cardiac disturbances including the following conditions. (1) Unmeasurable QT interval by ECG (2) Complete left bundle branch block (3) Use of a ventricular pacemaker (4) Congenital long QT syndrome or family history of long QT syndrome (5) History or complication of serious ventricular or atrial tachycardia (6) Clinically serious resting bradycardia(<50 bpm) (7) History of clinically diagnosed myocardial infarction (8) History of unstable angina within 12 months before start of study (9) Other clinically important heart diseases 5)Patient who has CNS involvement of leukemic cells 6)Patient who has severe or not-controlled illness other than CML 7)Patient who has a hereditary or acquired bleeding illness unrelated to CML 8)Patient who has a history of non-adherence to medications or patient from whom an informed consent can not be obtained. 9) 10)Patient who has any gastrointestinal disorders or diseases which may affect the absorption of the study drug. 11)Patients who has a history of acute or chronic pancreatitis within one year. 12)Patients who has hepatic disease, pancreatic disease, or severe renal disease unrelated to the primary disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of twice daily administration of Nilotinib at a dose of 300 mg in newly diagnosed Ph chromosome-positive (Ph+) CML patients based on the rate of major molecular response at 12 months after starting treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To assess the rate of complete cytogenetic response (CCyR), major molecular response and (MMR) and complete molecular response (CMR) every 12 months by 24 months. 2) To assess the level of bcr-abl mRNA in peripheral blood by QRT-PCR, Amp-CML and neutrophil FISH every 3 months. To validate the correlation of each methods. 3) To assess the level of bcr-abl mRNA in bone marrow by QRT-PCR every 12 months by 24 months. 4) To assess the progression-free survival (PFS), the event-free survival (EFS), and the overall survival (OS) at 5 years. 5) To assess the actual dose intensity at 12 months in the groups which have achieved a MMR and the groups which have not achieved a MMR. 6) To assess the safety of twice daily administration of Nilotinib 300 mg dosage. 7) To evaluate the utility of drug-sensitivity test by FRET analysis. | — |
Countries
Japan
Contacts
Public ContactTakeshi Kondo
Hokkaido University Hospital Department of Hematology
Outcome results
None listed