Efficacy of Decitabine in Clearance of MRD
Efficacy of Decitabine in Clearance of MRD
In this open-label, prospective clinical trial, the investigators enrolled acute myeloid
 leukemia (AML) patients after consolidation therapy. Patients with minimal residual disease
 (MRD) receive decitabine treatment if patients do not receive stem cell transplantation. The
 MRD clearance rate is the primary outcome to measure the efficacy of decitabine regimen.
In this open-label, prospective clinical trial, acute myeloid leukemia (AML) patients after
 consolidation therapy are enrolled. Patients with minimal residual disease (MRD) after
 consolidation therapy receive decitabine treatment if patients do not receive stem cell
 transplantation. The treatment regimen includes three course of decitabine regimen at a dose
 of 20mg/m² on day1-5. The MRD clearance rate is the primary outcome to measure the efficacy
 of decitabine regimen.
Inclusion Criteria:

 1. Age of 14 to 55 years old;

 2. Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML after
 consolidation regimen.

 3. Patients who had received induction and consolation therapy and reached CR.

 4. ECOG score of ≤ 2;

 5. Patients with eligible laboratory examination including liver,renal and heart
 function.

 6. Adult patients are willing to participate in the study and sign the informed consent
 by themselves or by their immediate family. Patients under 18 years old willing to
 participate should have their legal guardians sign the informed consent.

 Exclusion Criteria:

 1. Secondary leukemia.

 2. Patients had other tumor at active stage or had received radiotherapy or chemotherapy
 in the last 6 months due to other tumor.

 3. Patients with other blood diseases(for example, haemophiliacs) are excluded.However,
 undiagnosed MDS or MPD patients are included.

 4. Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;

 5. With BCR-ABL fusion gene;

 6. Pregnant or lactating women;

 7. With ineligible renal or liver function;

 8. With active cardiovascular disease;

 9. Severe infection disease including uncured tuberculosis pulmonary aspergillosis;

 10. AIDS;

 11. Patients had central nervous system involvement when they were diagnosed as AML.

 12. Patients with epilepsy or dementia or other mental disease who couldn't understand or
 follow the research.

 13. Drugs, medical, mental or social situation may distract patients from following the
 research or being evaluated the results.

 14. Patients with other factors which were considered unsuitable to participate in the
 study by the investigators.