NCT00769327

Nilotinib and Imatinib Mesylate in Treating Patients With Early Chronic Phase Chronic Myelogenous Leukemia

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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.

Conditions

• Leukemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-02-09
• Primary completion: 2014-10-01
• Completion: 2014-10-10
• First posted: 2008-10-09
• Last updated: 2022-01-04

Locations

37 sites across 1 country: Italy