Acute Myeloid Leukemia
Conditions
Interventions
Experimental group:DCAG+ umbilical cord blood stem cell microtransplantation+IL-2
Control Group:pure chemotherapy with DCAG
Sponsors
Department of Hematology, Jiangsu Provincial Hospital
Eligibility
Sex/Gender
All
Age
60 Years to 80 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), except for hydroxyurea or leukopheresis; 3. morphology and immunophenotyping excluded acute promyelocytic leukemia (APL); 4. Aged 60-80 years old; 5. ALT, AST and serum bilirubin =50% by echocardiogram; 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 8. 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. with obvious dysfunction of liver or kidney, not fulfilling the inclusion criteria; 6. with organic heart disease, which causes clinical symptoms or cardiac dysfunction ( >=Class 2 cardiac disease as defined by the New York Heart Association Functional Classification, NYHA); 7. 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); 8. known history of human immunodeficiency virus (HIV) or syphilis, or active infection with Hepatitis B (HBV-DNA positive) or Hepatitis C; 9. currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, or history of myocardial infarction within 6 months prior to first dose with study drug, or any Class 3 or 4 cardiac disease as defined by NYHA; 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. received major surgery within 4 weeks prior to randomization; 13. 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 response rate;partial response rate;2-year disease-free survival;early mortality;minimal residual disease;immunal function after treatment;hematopoetic recovery time; | — |
Countries
China
Contacts
Public ContactMing Hong
Jiangsu Provincial Hospital
Outcome results
None listed