The goal of this phase I/II clinical trial is to test in high-risk acute myeloid leukemia (AML) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is: • The efficacy and safety of chidamide maintenance therapy in reducing the recurrence rate and GVHD incidence in high-risk AML patients after allo-HSCT. Participants will take oral chidamide (Epidaza) until 180 days after allo-HSCT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
77
initial time:platelet count ≥50×10\^9/L after allo-HSCT initial dose: 5 mg oral twice weekly initial adjustment: according to the platelet count tested weekly platelet count ≥50×10\^9/L-increased by 5 mg 20×10\^9/L≤ platelet count \<50×10\^9/L-remains unchanged platelet count \<50×10\^9/L- reduced by 5 mg maximum dose: 20 mg oral twice weekly terminal time: 180 days after allo-HSCT
West China Hospital of Sichuan University
Chengdu, Sichuan, China
RECRUITINGProgression free survival (PFS)
Progression free survival of this group of patients at the end of 2 year
Time frame: 2 years
100 day adverse events (AE)
non-hematologic adverse events
Time frame: Day +100
Non-relapse mortality (NRM)
Non-relapse mortality of this group of patients at the end of 6 month
Time frame: 6 months
Overall survival (OS)
Overall survival of this group of patients at the end of 2 year
Time frame: 2 years
Relapse rate
Relapse rate of this group of patients at the end of 2 year
Time frame: 2 years
Cumulative incidence of acute graft versus host disease (aGVHD)
Cumulative incidence of acute graft versus host disease (aGVHD) of this group of patients at day+100
Time frame: Day +100
Cumulative incidence of chronic graft versus host disease (cGVHD)
Cumulative incidence of chronic graft versus host disease (cGVHD) of this group of patients at the end of 2 year
Time frame: 2 years
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