Nilotinib in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
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.
Genetic: cytogenetic analysis
Genetic: mutation analysis
Genetic: polymerase chain reaction
Other: pharmacological study
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- 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 ]
|Study Start Date:||October 2008|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
|Experimental: Nilotinib||Drug: nilotinib Genetic: cytogenetic analysis Genetic: mutation analysis Genetic: polymerase chain reaction Other: pharmacological study|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00809211
|United States, Texas|
|University of Texas Health Science Center at San Antonio|
|San Antonio, Texas, United States, 78229-3900|
|Universitätsklinikum Charité Berlin|
|Belfast City Hospital|
|St. James's Hospital|
|Dublin, Ireland, 8|
|University College Hospital|
|Chaim Sheba Medical Centre|
|Tel Hashomer, Israel|
|Principal Investigator:||Mike O'Dwyer, MD||University College London Hospitals|