Chronic myelogenous leukemia
Conditions
Interventions
Sponsors
Nara Hospital Kinki University School Of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with Chronic Myeloid Leukemia (CML) in chronic phase, diagnosed with Philadelphia chromosome positive (Ph+) 2) Patients diagnosed with failure or intolerant for prior Imatinib therapy. 3) Patients over or equal to 15 years of age 4) ECOG performance status score of 0-2 5) Patients with acceptable internal organs function meet the following requirements. Serum creatinine concentration less than 3 x the upper limit of the normal range of the laboratory where the analysis is performed. Total serum bilirubin level less than 3 x the upper limit of the normal range of the laboratory where the analysis is performed. AST(GOT) and ALT(GPT) level less than 5 x the upper limit of the normal range of the laboratory where the analysis is performed. Lipase level less than 2 x the upper limit of the normal range of the laboratory where the analysis is performed. QTc interval under or equal to 480 msec. 6) NYHA criteria class of 1-2 7) Patients who can receive treatment at fixed intervals on outpatient basis 8) Informed consent signed up.
Exclusion criteria
Exclusion criteria: 1) Patients suspected in accelerated phase(AP) or in blast crisis(BC). 2) Confirmed the expression of T315I mutation at genetic screening. 3) Previously treated with any other agents or therapy for CML, other than Hydroxyurea, Interferon-alfa, and Imatinib. 4) History of a invasive double cancer within 5 years before. 5) Presence of serious or uncontrolled concomitant disease. 6) Pregnancy or possibility of pregnancy positive. 7) Women with lactation status or patients who have willing of pregnancy. 8) Patients suffering mental disorder or psychotic symptom.
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. | — |
Countries
Japan
Contacts
Public ContactKazuo Tsubaki
Nara Hospital Kinki University School Of Medicine Department of Hematology
Outcome results
None listed