Chronic myelogenous leukemia
Conditions
Interventions
Sponsors
East Japan CML Study Group (EJCML)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patient who has the Philadelphia chromosome confirmed by chromosome analysis at the first visit. 2) Patient who has not experienced a blast phase of CML before treatment with Nilotinib. 3) Chronic or accelerate phase CML patients who has been treated with Imatinib for 18 months or longer and diagnosed with Imatinib resistance or intolerance. 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 a history of non-adherence to medications or patient from whom an informed consent can not be obtained. 6) Patient who has any gastrointestinal disorders or diseases which may affect the absorption of the study drug. 7) Patients who has acute or chronic 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 400 mg in Ph chromosome-positive (Ph+) CML patients with Imatinib resistance or intolerance 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) at 12 months. 2) To assess the times to achieve a CCyR and a major molecular response (MMR) every 3 months. 3) To assess durations of MMR every 3 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 CCyR or a MMR and the groups which have not achieved a CCyR or a MMR. 6) To assess patient profiles such as BCR-ABL point mutations and the blood levels of Imatinib before Nilotinib treatment. 7) To assess profiles of BCR-ABL point mutations at 12 months in the groups which have achieved a CCyR and a MMR and in the groups which have not achieved a CCyR and a MMR. 8) To assess the safety of twice daily administration of Nilotinib 400 mg dosage. | — |
Countries
Japan
Contacts
Public ContactNaoto Takahashi
Akita University School of Medicine Department of Hematology, Nephrology, and Rheumatology
Outcome results
None listed