Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase (ENACT)
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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.
An Open-label, Multicenter Study Providing Continuation of Nilotinib in Adult Patients With Imatinib-(Glivec®/Gleevec®) - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
Study Start Date :
Estimated Primary Completion Date :
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Ages Eligible for Study:
18 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Having participated in Novartis study CAMN107A2109, and
Written signed and dated informed consent prior to any study procedures being performed.
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/exclusion criteria may apply