Chronic Myeloid Leukemia
Conditions
Keywords
chronic myeloid leukemia,, blast crisis,, accelerated phase,, nilotinib,, imatinib,, resistant,, intolerant,, chronic phase
Brief summary
Multi-center, open-label, non-randomized trial to evaluate long-term safety and efficacy of nilotinib. Approximately 20 patients will be enrolled in this trial at 3 centers in Mexico, which means all ongoing patients participating on \[CAMN107A2109\] excluding discontinued patients. During this study, patients will receive nilotinib orally, at a dose of 400 mg b.i.d. Patients will normally receive nilotinib on an outpatient basis. This trial will have a maximum of 24 months of follow-up time.
Interventions
DRUGNilotinib
Sponsors
Novartis Pharmaceuticals
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Having participated in Novartis study CAMN107A2109, and * Written signed and dated informed consent prior to any study procedures being performed.
Exclusion criteria
* Impaired cardiac function, * Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon) up to the day before study drug administration; Other concurrent severe and/or uncontrolled medical conditions, * Patients who are currently receiving treatment with any of the medications that have the potential to prolong the QT interval, * patients who have undergone a major surgery and have not recovered from side effects of such therapy within 15 days, * Patients who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control, OR * Patients unwilling or unable to comply with the protocol. Other protocol -defined inclusion/
Countries
Mexico
Outcome results
None listed