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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Universitätsklinikum Charité Berlin
Berlin, Germany
Belfast City Hospital
Belfast, Ireland
St. James's Hospital
Dublin, Ireland
Complete cytogenetic response rate at 6 months as assessed by metaphase analysis
Time frame: 6 months
Molecular response rate at 3, 6, 9, 12, 18, and 24 months as assessed by quantitative PCR
Time frame: 6 months
Time to disease progression
Time frame: 6 months
Duration of event-free survival
Time frame: 6 months
Overall toxicity rate
Time frame: 6 months
Correlation of pharmacokinetic data with response rate and toxicity
Time frame: 6 months
Correlation of Bcr-Abl results using GeneXpert with Bcr-Abl results using international standardized quantitative PCR
Time frame: 6 months
Prevalence of Bcr-Abl mutations prior to and during treatment
Time frame: 6 months
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University College Hospital
Galway, Ireland
Chaim Sheba Medical Centre
Tel Litwinsky, Israel