Acute Myeloid Leukemia
Conditions
Interventions
Study group:decitabine/azacitidine+IA
Sponsors
Department of Hematology, Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: 1. AML patients diagnosed due to bone marrow morphology and immunophenotyping (met the WHO 2016 diagnosis criterion); 2. without a history of anti-leukemia treatment (including hypomethylating agents and hydroxyurea), except for leukopheresis; 3. morphology and molecular biology excluded acute promyelocytic leukemia (APL); 4. Aged 18 to 60 years old; 5. PLT count >10 x 10^9/L; 6. ALT, AST and ALP =50% by echocardiogram; 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 9. must sign (or their legally-acceptable representative must sign) an informed consent form indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion criteria
Exclusion criteria: 1. acute promyelocytic leukemia, myeloid sarcoma, or accelerated or blastic phase of chronic myelogenous leukemia; 2. relapsed AML patients; 3. allergic to any of the mentioned agent in the study protocol; 4. pregnant or lactating women, or patients during reproductive stage but not willing to take contraception methods; 5. platelet count =Class 3 cardiac disease as defined by the New York Heart Association Functional Classification, NYHA), such as uncontrolled or symptomatic arrhythmia, congestive heart failure or cardiac infarction within 6 months; 8. at the same time suffering from other malignant tumors, with the exception of the following: (1) malignancy treated with curative intent and with no evidence of active disease present for more than 5 years prior to screening; (2)adequately treated lentigo maligna melanoma without current evidence of disease or adequately-controlled non-melanomatous skin cancer (even if less than 3 years prior to screening); (3) adequately treated cervical carcinoma in situ without current evidence of disease (even if less than 3 years prior to screening); 9. known history of human immunodeficiency virus (HIV) or syphilis, or active infection with Hepatitis B (HBV-DNA positive) or Hepatitis C; 10. any concurrent medical condition or disease (eg, active systemic infection) that may interfere with the research procedure or outcome, or that the subject may have a risk to participate in the study; 11. cannot understand or follow the study protocol; 12. older than 60 years old or younger than 18 years old; 13. received major surgery within 4 weeks prior to randomization; 14. participated in other clinical researches at the same time one month before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year overall survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| complete remission rate;overall remission rate;2-year disease free survival rate; | — |
Countries
China
Contacts
Public ContactSi-Xuan Qian
Jiangsu Province Hospital
Outcome results
None listed