Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) with Dasatinib (BMS-354825)
The goal of this clinical research study is to learn if BMS-354825 (dasatinib) can help to control CML in chronic phase. The safety of this drug will also be studied.
Treatment Location: N/A
Primary: · To estimate the proportion of patients with previously-untreated chronic phase CML attaining major molecular response by 12 months of treatment with dasatinib. Secondary: · To estimate the proportion of patients with Ph-positive early chronic phase CML achieving a complete cytogenetic response after dasatinib therapy. · To evaluate the durations of hematologic, cytogenetic and molecular response to dasatinib. · To define the time to progression and overall survival for patients with CML in early chronic phase treated with dasatinib. · To evaluate the toxicity profile of dasatinib in patients with CML in early chronic phase. · To evaluate the probability of developing ABL mutations for patients with CML in early chronic phase treated with dasatinib. · To analyze differences in response rates and in prognosis within different risk groups and patient characteristics. To assess correlation between trough concentration and pleural effusion. To assess the inhibition of platelet function and assess correlation between drug concentration and degree of platelet inhibition. To assess the effect of dasatinib therapy in bone metabolism as determined by changes in serum alkaline phosphatase (bone specific isoenzyme) and trabecular bone volume. To evaluate symptom burden in patients with CML receiving dasatinib Exploratory Objective: To investigate the plasma/serum levels of specific miRNAs in CML patients receiving dasatinib as initial therapy for CML in CP.
IRB Review and Approval Date: JUL 6,2005
Recruitment Status: Closed
Projected Accrual: N/A