Chidamide Prevents Recurrence of High-risk AML After Allo-HSCT

Prior treatment

• Participating in other clinical studies, or planning to start treatment in this study and less than 4 weeks before the end of treatment in the previous clinical study;

Other illness

• Serious basic diseases of important organs: such as myocardial infarction, chronic cardiac insufficiency, decompensated hepatic insufficiency, renal function, gastrointestinal insufficiency, etc.;
• Uncontrolled active infection (including bacterial, fungal, or viral infection), and drug treatment is ineffective;
• Combined with other malignant tumors and require treatment;
• Have a history of allergy to Chidamide;
• Patients with known history of human immunodeficiency virus (HIV) virus infection and/or acquired immunodeficiency syndrome;
• Patients with active chronic hepatitis B or active hepatitis C;

Lab values

• History of prolonged QT syndrome;

Other

• Poor graft function (PGF) occurred after allo-HSCT;
• Active GVHD;
• Pregnant or lactating females;
• Patients considered by other researchers to be unsuitable for this study.

• Age ≥ 18 years old and ≤ 65 years old when signing the Informed Consent Form (ICF);
• KPS score \> 60 or ECOG score 0-2;
• The expected survival period \> 3 months;
• Received allo-HSCT and achieved complete remission (CR);
• Reach the standard of hematopoietic reconstitution (neutrophil count ≥ 0.5×10\^9/L for 3 consecutive days without G-CSF application, platelet count ≥ 20×10\^9/L for 7 consecutive days without platelet transfusion, Hb ≥ 80 g /L without red blood cell transfusion); and neutrophil count ≥ 1.5×10\^9/L, platelet count ≥ 50×10\^9/L within 45 days after transplantation;
• No central nervous system involvement or clinical symptoms after transplantation;
• Those who have no serious functional damage to important organs of the body;
• Fully understand and be informed of this study and sign the ICF; willing to follow and have the ability to complete all test procedures;
• Females of childbearing age must afford a serum pregnancy test within 7 days before the first dose, and the result should be negative; female participants and their partners should agree to use effective contraception from signing the ICF until 6 months after the last dose.