Leukemia Clinical Trial
Official title:
A Phase II Multi-center, Open-label, Study of Nilotinib at a Dose of 300mg Twice Daily in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
RATIONALE: Nilotinib may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth.
PURPOSE: This phase II trial is studying how well nilotinib works in treating patients with
newly diagnosed chronic phase chronic myelogenous leukemia.
OBJECTIVES:
Primary
- To establish the complete cytogenetic response rate at 6 months in patients with newly
diagnosed Philadelphia chromosome-positive chronic phase chronic myelogenous leukemia
treated with nilotinib.
Secondary
- To establish the complete cytogenetic response rate at 3, 9, 12, 18, and 24 months in
these patients.
- To establish the molecular response rate at 3, 6, 9, 12, 18, and 24 months in these
patients.
- To establish the safety of this drug in these patients.
- To correlate pharmacokinetic data with response rate and toxicity.
- To correlate Bcr-Abl results using GeneXpert with Bcr-Abl results using international
standardized quantitative PCR.
- To estimate the prevalence of Bcr-Abl mutations prior to and during treatment.
OUTLINE: This is a multicenter study.
Patients receive oral nilotinib twice daily on days 1-28. Treatment repeats every 28 days for
up to 24 courses in the absence of disease progression or unacceptable toxicity.
Peripheral blood and bone marrow samples are collected periodically for mutation analysis,
Bcr-Abl analysis by quantitative PCR, metaphase cytogenetics, and pharmacokinetic analysis.
After completion of study therapy, patients are followed every 3 months for 2 years.
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