NCT00809211

Nilotinib in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Cancer Trials Ireland · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	nilotinib
GENETIC	cytogenetic analysis
GENETIC	mutation analysis
GENETIC	polymerase chain reaction
OTHER	pharmacological study

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-05-01
• Completion: 2016-02-01
• First posted: 2008-12-17
• Last updated: 2018-07-24

Locations

6 sites across 4 countries: United States, Germany, Ireland, Israel