Phase I-II Study of Low-Dose Azacitidine (Vidaza) in Patients With Chronic Myeloid Leukemia who Have Minimal Residual Disease While Receiving Therapy with Tyrosine Kinase Inhibitors (VZ-CML-PI-0236)
This is a 2 part study. The goal of the first part of this clinical research study is to find the highest tolerable dose of azacitidine that can be given with a TKI that you are already taking (such as Gleevec, Sprycel, or Tasigna). The safety of this drug will also be studied. The goal of the second part is to see if this combination may improve your response to the TKI you are already taking. Azacitidine is designed to change genes that are thought to cause leukemia. By changing these genes, the drug may help to stop them from causing the disease to grow.
Treatment Location: N/A
Primary Objective: Phase I: To determine the DLT and MTD of the combination of azacitidine (AZA) and a tyrosine kinase inhibitor (TKI) in patients with chronic myeloid leukemia (CML). Phase II: To determine the clinical activity of the combination of AZA and a TKI in patients with CML in complete cytogenetic remission (CCyR) with minimal residual disease. Secondary Objectives: Phase I To determine the clinical activity of the combination of AZA and a TKI in patients with CML Phase II To determine the safety of the combination of AZA and a TKI in patients with CML in CCyR with minimal residual disease. Both phases Determine the effect of therapy over DNA methylation. Investigate the correlation of DNA methylation and response to therapy.
IRB Review and Approval Date: 08/08/2012
Recruitment Status: Closed
Projected Accrual: N/A