Official Title
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
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.

Approved for marketing
Chronic Myeloid Leukemia

Drug: Nilotinib

Eligibility Criteria

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/exclusion criteria may apply

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years~Maximum: 60 Years
Countries
Mexico

Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals

Novartis Pharmaceuticals
NCT Number
Keywords
chronic myeloid leukemia
blast crisis
accelerated phase
nilotinib
imatinib
resistant
intolerant
chronic phase
MeSH Terms
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Blast Crisis