Nilotinib will be evaluated in patients having showed a suboptimal cytogenetic response to imatinib
Conditions
Interventions
Product Name: nilotinib
Product Code: AMN107
Pharmaceutical Form: Capsule, hard
Current Sponsor code: AMN107
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
T
Sponsors
Novartis Pharma Services
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients = 18 years of age. ECOG performance status of 0,1, or 2. Diagnosis of Ph+ CML-CP defined as: / 100,000 /mm3) platelets No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly Patients with suboptimal cytogenetic response to a dose of at least 400 mg imatinib defined as = 6 to =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Prior accelerated phase or blast phase CML. Previously documented T315I mutation. Achieved prior PCyR or CCyR and lost that response prior to entering the study. Presence of chromosomal abnormalities (trisomy 8) and/or clonal evolution other than Ph+. Patients who have received more than 18 months of imatinib therapy. Intolerance to imatinib 400 mg/day defined as the inability to maintain dosing of at least 400 mg daily for the previous 3 months. Previous treatment with any other tyrosine kinase inhibitor except imatinib. Impaired cardiac function including any of the following: LVEF by echocardiography 1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads; congenital long QT syndrome or family history of; history or presence of significant ventricular or atrial tachyarrhythmias; clinically significant resting brachycardia ( 450 msec at baseline; right bundle branch block plus left anterior hemiblock, bifascicular block; myocardial infarction = 3 months; uncontrolled angina; other clinically significant heart disease (e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with antihypertensives). Treatment with strong inhibitors of CYP3A4 or medications that have been well documented to prolong the QT interval is contraindicated (see Concomitant Therapy section in protocol).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the complete cytogenetic response (CCyR ) rate at 12 months of nilotinib compared to imatinib in adult patients with Ph+ CML in CP who have a suboptimal cytogenetic response to imatinib.;Secondary Objective: To evaluate the rate of major molecular response (MMR) of nilotinib compared to imatinib in adult patients with Ph+ CML in CP at 12 months. To evaluate the rate of complete molecular response (CMR) of nilotinib compared to imatinib in adult patients with Ph+ CML in CP at 12 months. To evaluate the time to and duration of CCyR of nilotinib compared to imatinib in adult patients with Ph+ CML in CP. To evaluate the time to and duration of MMR of nilotinib compared to imatinib in adult patients with Ph+ CML in CP. To evaluate the time to and duration of CMR of nilotinib compared to imatinib in adult patients with Ph+ CML in CP. To describe overall survival and progression-free survival up to 5 years in adult patients with Ph+ CML in CP. To evaluate the safety profile of nilotinib compared to imatinib in adult patients with Ph+ CML in CP. ;Primary end point(s): Primary efficacy Complete cytogenetic Response (CCyR) rate at 12 months (CCyR is defined as 0% Ph+ metaphases) | — |
Countries
Belgium, Czech Republic, France, Germany, Greece, Hungary, Italy, Netherlands, Spain
Outcome results
None listed