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

Novartis Pharmaceuticals

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

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
EA 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, Imatinib Mesylate
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