Chidamide Plus DCAG for Relapsed/Refractory AML
Chidamide Plus DCAG for Relapsed/Refractory AML
Despite advances in understanding the complexities of acute myeloid leukaemia (AML), the
 treatment of refractory or relapsed AML (rrAML) remains a daunting clinical challenge.The
 investigators designed a new regimen, including chidamide, decitabine, aclarubincin,
 cytarabine and G-CSF, to treat rrAML.
Inclusion Criteria:

 -  Men and women whose age more than 18 and less than 59；

 -  Patients diagnosed as AML according to the 2008 WHO (WHO) myeloid malignant disease
 diagnosis standard;

 -  Patients who relapsed after remission or who can not achieve remission after at least
 two cycle of systemic therapy (including chemotherapy, hematopoietic stem cell
 transplantation, etc.);

 -  ECOG performance status 0-3;

 -  Expected survival time ˃ 3 months;

 -  Patients without serious hearts, lung, liver, kidney disease;

 -  Patients have not received radiotherapy, chemotherapy, targeted therapy or
 hematopoietic stem cell transplantation and other treatment within 4 weeks prior to
 the enrollment;

 -  Patients are able to understand and willing to sign informed consent.

 Exclusion Criteria:

 -  Patients who allergy to the study drug or the drug with similar chemical structure;;

 -  Pregnancy, lactation women and women of childbearing age who do not want to practice
 effective methods of contraception;

 -  Active infection;

 -  Drug abuse, long-term alcohol abuse so as to affect the results of the evaluation of
 patients;

 -  Patients with mental disorders or other conditions can not obtain informed consent,
 can not meet the requirements of the study treatment and procedures;

 -  Patients have clinical significant QTc interval prolongation history (male > 450ms.
 Female >470ms), ventricular heart had tachycardia (VT) and atrial fibrillation (AF),
 II degree heart block, myocardial infarction attack (MI) within 1 year prior to the
 enrollment, congestive heart failure (CHF), patients of coronary heart disease who
 have clinical symptoms and need drug treatment.

 -  Cardiac ultrasound showed that the diastolic pericardial fluid dark area width ˃ 10mm;

 -  Patients have received organ transplantation;

 -  Active bleeding

 -  Patients have new thrombosis, embolism, cerebral hemorrhage and other diseases or
 medical history of patients within 1 year prior to enrollment;

 -  The main organs of the surgery is less than 6 weeks;

 -  Bone marrow hyperplasia and WBC <2.0 * 10^9/L;

 -  Liver function abnormalities (total bilirubin > 1.5 times of upper limit of normal
 range , ALT / AST > 2.5 times of the upper limit of normal range or patients with
 liver involvement whose ALT / AST > 1.5 times of upper limit of normal range), renal
 anomalies (serum creatinine > 1.5 times of upper limit of normal value );

 -  Not suitable for the study according to investigator's assessment.