Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) with Oral Nilotinib
The goal of this clinical research study is to learn if an experimental agent, AMN107 (nilotinib), can help to control CML in chronic phase. The safety of this experimental agent will also be studied.
Treatment Location: N/A
Primary: To determine the percentage of patients who achieve low levels of PCR ratios of Bcr-Abl/Abl (molecular CR) after 12 months of therapy with nilotinib. Secondary: To determine the proportion of patients with Ph-positive early chronic phase CML achieving a complete cytogenetic response after nilotinib therapy, and the time to achieve the response. To evaluate the durations of PCR negativity, cytogenetic response, hematologic control, and survival. To analyze differences in response rates and in prognosis within different risk groups and patient characteristics. To evaluate symptom burden inpatients with CML receiving nilotinib.
IRB Review and Approval Date: APR 20,2005
Recruitment Status: Closed
Projected Accrual: N/A