Phase 2/3 Study of Efficacy Study of CHG Regimen vs Decitabine to Treat Higher-risk MDS
Patients with higher-risk myelodysplastic syndrome (MDS) have a survival rate of 0.4 to 1.2
years as well as a high risk of their disease progressing to acute myeloid leukemia (AML).
The only treatment with a curative potential is allogeneic stem cell transplantation.
However, in the majority of patients, this treatment is not applicable, mainly due to the
age of the recipients and comorbid conditions. Low-dose chemotherapy CHG regimen (low-dose
cytarabine, homoharringtonine with G-CSF priming)has been used to treat higher-risk MDS in
China and achieve high response rate. Hypomethylating agents 5-aza-2'-deoxycytidine
(decitabine) is nucleoside analogs that covalently bind to the DNA methyltransferases,
irreversibly inhibiting their function, leading to the progressive loss of methylation and
reversal of gene silencing. The purpose of this study is to compare the efficacy and safety
of CHG regimen to Decitabine in higher-risk MDS.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
complete remission rate
four weeks after one course of CHG or two courses of Decitabine
Xiao Li, Doctor
Shanghai 6th People's Hospital
China: Food and Drug Administration