Oral Nilotinib in Adults With Chronic Myeloid Leukemia (CML) in Blast Crisis Who Are Imatinib Resistant or Intolerant

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

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Study Start Date

2006-12-31

Brief Summary

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This study will evaluate the safety of nilotinib in adult patients with imatinib-resistant or -intolerant CML-blast crisis, CML-accelerated phase or CML-chronic phase when treated with nilotinib. Patients will be provided access to nilotinib until the drug is available on the market.

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Detailed Description

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Conditions

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Chronic Myelogenous Leukemia

Interventions

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nilotinib

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Imatinib resistant or intolerant Philadelphia chromosome positive CML in blast crisis
* Imatinib resistant or intolerant Philadelphia chromosome positive CML in accelerated phase
* Imatinib resistant or intolerant Philadelphia chromosome positive CML in chronic phase
* CML patients who have been treated with an investigational tyrosine kinase inhibitor who otherwise meet the definition of imatinib resistance or intolerance
* World Health Organization (WHO) performance status ≤ 2

Exclusion Criteria

* Cytopathologically confirmed central nervous system (CNS) infiltration
* Impaired cardiac function
* Use of therapeutic coumarin derivatives
* Acute chronic liver or renal disease unrelated to tumor
* Other uncontrolled medical conditions
* Treatment with hematopoeitic colony stimulating factors
* Treatment with medications that have potential to prolong the QT interval
* Another malignancy currently clinically significant or requires active intervention

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No