OAG and Decitabine for Newly Diagnosed Acute Myeloid Leukemia Patients Greater than or Equal to 65 Years of Age

The primary objective of this onearm Phase II trial is to assess the efficacy of the study treatment as compared to historical control. Differing response rates have been seen in poor prognosis patients (defined as adverse karyotype vs. all others). Therefore, we utilize a stratified design to account for this. True complete response rates (CR) of less than 10% and 30% in the poor and good prognostic groups are considered unacceptable. Complete response rates of more than 30% and 40% in the two groups are considered promising, and evidence of such will deem the treatment worthy of further study.

Study Number: 

I 245213

Principal Investigator: 
ClinicalTrials.Gov ID: 

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