Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Study Start Date

2008-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Myeloid Leukemia

Interventions

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Nilotinib

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No