Chronic myelogenous leukemia
Conditions
Interventions
Nilotinib will be administered twice daily at a dose of 400 mg (800 mg/day) for 2 year.
Sponsors
Shimousa Hematology Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with cytogenetically confirmed newly diagnosed Ph+CML-CP. 2) CML-CP patients who have been treated with Imatinib for 3 months or longer and diagnosed with Imatinib resistance or intolerance. 3) ECOG performance status of 0-2. 4) Patients who have not experienced a blast phase or accelerated phase of CML before treatment with Nilotinib. 5) Adequate organ function. 6) Patients who are able to attend the study institution in accordance with the designated follow-up visit schedule. 7) Written informed consent prior to any study procedures being performed.
Exclusion criteria
Exclusion criteria: 1) Patients who have been treated with tyrosine kinase inhibitors (except for imatinib) prior to study entry. 2) Patients whose clone exhibit the T315I BCR-ABL mutation. 3) Patients who have any cardiac disturbances. 4) Patients who are: (a) pregnant, (b) breast feeding, (c) male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial. 5) Severe medical conditions. 6) Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the rate of major molecular response at 12 months of nilotinib therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To evaluate the response rates at 12 and 24 months of nilotinib therapy. 2) To evaluate the safety of nilotinib 3) To assess the progression-free survival (PFS), the event-free survival (EFS), and the overall survival (OS) at 3 years. | — |
Countries
Japan
Contacts
Public ContactKuniaki Itoh
National Cancer Center Hospital East Division of Oncology/Hematology
Outcome results
None listed