Clinical Research for Azacitidine Combined With Low-dose Dasatinib in Maintenance Therapy of Acute Myeloid Leukemia
Status:
Recruiting
Trial end date:
2023-12-15
Target enrollment:
Participant gender:
Summary
This project is a prospective, single-center study to evaluate the efficacy, safety and
related mechanisms of azacitidine combined with low-dose dasatinib in maintenance therapy in
patients with intermediate and high-risk acute myeloid leukemia(AML). The patients were
randomly divided into azacitidine group and azacitidine combined with low-dose dasatinib
group. The overall survival and disease-free survival were taken as the main end points, and
the mortality and recurrence rate were taken as the secondary end points, meanwhile, the
incidence of adverse events were evaluated. At the same time, the mRNA expressions of DNA
methyltransferase (DNMT1, DNMT3a, DNMT3b), tumor suppressor genes (TP53, P15, P16, P21, CDH1,
DOK6, SHP1, PTPN11) and differentiation genes (pu.1, C/EBP α, C/EBP β) were detected.
Pyrophosphate sequencing was used to detect the methylation level of the promoter region of
these tumor suppressor genes. Western Blot was used to detect apoptosis proteins (caspase3,
caspase8) and phosphorylated proteins (pSTAT3, pSTAT5, pAKT). The proportion of apoptotic
population of bone marrow cells was determined by flow cytometry. Therefore, the data in this
study will reflect the efficacy and safety of azacitidine or azacitidine combined with
low-dose dasatinib in real-world maintenance therapy in patients with medium and high-risk
AML.