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

• Conditions: Chronic Myeloid Leukemia

• Registration Number: NCT00905593
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-05-18
• Study First Submitted QC: 2009-05-19
• Study First Posted: 2009-05-20
• Primary Completion: 2011-04
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-17
• Last Update Posted: 2012-07-18

Recruitment & Eligibility

• Status: APPROVED_FOR_MARKETING
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (1)

Novartis Investigative Site; 🇲🇽 Mexico City, Mexico