Nilotinib in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
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|ClinicalTrials.gov Identifier: NCT00809211|
Recruitment Status : Active, not recruiting
First Posted : December 17, 2008
Last Update Posted : May 31, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: nilotinib Genetic: cytogenetic analysis Genetic: mutation analysis Genetic: polymerase chain reaction Other: pharmacological study||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||February 15, 2016|
Genetic: cytogenetic analysis
Genetic: mutation analysis
Genetic: polymerase chain reaction
Other: pharmacological study
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|