Nilotinib and Imatinib Mesylate in Treating Patients With Early Chronic Phase Chronic Myelogenous Leukemia (CML0408)
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|ClinicalTrials.gov Identifier: NCT00769327|
Recruitment Status : Completed
First Posted : October 9, 2008
Last Update Posted : January 28, 2015
RATIONALE: Nilotinib and imatinib mesylate 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 giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: imatinib mesylate Drug: nilotinib Genetic: cytogenetic analysis Genetic: fluorescence in situ hybridization Genetic: microarray analysis Genetic: mutation analysis Genetic: polymerase chain reaction Genetic: polymorphism analysis Other: laboratory biomarker analysis||Phase 2|
- To assess the complete cytogenetic response rate at 12 months in patients with Philadelphia chromosome- and BCR-ABL-positive early chronic phase chronic myelogenous leukemia treated with nilotinib and imatinib mesylate.
- To assess the complete cytogenetic response rate at 6 and 24 months in these patients.
- To assess the major and complete molecular response rate at 6, 12, and 24 months in these patients.
- To assess the frequency and the types of BCR-ABL kinase domain mutations at 24 months during and for 3 years after study treatment.
- To assess the rate of failures and the time to failure at 12, 24, and 60 months in these patients.
- To assess compliance, toxicity, and adverse events in these patients.
- To understand the relationship between response, gene expression profile, biomarkers, and drug plasma concentrations in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral nilotinib twice daily in months 1-3, 7-9, 13-15, and 19-21 and oral imatinib mesylate once daily in months 4-6, 10-12, 16-18, and 22-24. Treatment continues for 24 months in the absence of disease progression or unacceptable toxicity. Patients may be eligible to continue oral nilotinib and oral imatinib mesylate for up to another 36 months if it is in the interest of the patient.
Blood samples and bone marrow biopsies are collected periodically for cytogenetic response by chromosome banding analysis and FISH analysis; real-time quantitative PCR mutational analysis and single nucleotide polymorphism analysis of BCR-ABL transcripts; and gene expression profiling and correlative biomarker studies.
After completion of study therapy, patients are followed every 6 months for 3 years and then every 12 months for 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||129 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Front-line Treatment of Philadelphia Positive (Ph Pos), BCRABL Positive, Chronic Myeloid Leukemia (CML) With Two Tyrosine Kinase Inhibitors (TKI) (Nilotinib and Imotinib) A Phase II Exploratory Multicentric Centre.|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
- Complete cytogenetic response rate [ Time Frame: At 12 months from study entry ]
- Complete cytogenetic response [ Time Frame: At at 6 and 24 months from study entry ]
- Major and complete molecular response rate [ Time Frame: At at 6, 12 and 24 months from study entry ]
- Development of BCR-ABL kinase domain mutations (number, timing, and type) [ Time Frame: At at 24 months during and for 3 years after study treatment ]
- Rate of failures and the time to failure [ Time Frame: At 12, 24, and 60 months from study entry ]
- Safety and tolerability [ Time Frame: At 24 months from study entry ]
- Frequency and type of adverse events (AE) and severe AE [ Time Frame: At 24 months from study entry ]
- Relationship between response, the gene expression profile, the biomarkers of leukemic cells, and plasma concentrations of nilotinib and imatinib mesylate [ Time Frame: At 24 months from study entry ]
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): NCT00769327
|Principal Investigator:||Michele Baccarani, MD||Gruppo Italiano Malattie EMatologiche dell'Adulto|