Acute non-lymphocytic leukemia and ?myelodysplastic syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Morphological, genetic, and flow cytometry confirmed acute myeloid leukemia with the standard of Diagnosis and treatment of blood diseases; 2. ECOG score: 0-2; 3. The expected survival time more than 3 months; 4. Main organ function: serum bilirubin is less than or equal to 1.5 ULN, ALT and AST is less than or equal to 2.5 ULN, serum Cr is less than or equal to 1.5 ULN; 5. subjects volunteered to try and signed the informed consent, signed informed consent process to meet the requirements of GCP.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed as acute premyelocyte leukemia; 2. Can not be drawn from the bone marrow; 3. Any time treated with azacitidine or decitabine; 4. Diagnosed with other malignant tumors in the previous 12 months; 5. Systematic fungal, bacterial or viral infection (defined as the symptom and signs are associated with infection, despite the use of antibiotics or other treatment, which are still not improved); 6. Known or suspected to be allergic to DEC; 7. Human immunodeficiency virus (HIV) or hepatitis B virus infection; 8. Previous history of definite neurological or psychiatric disorders, including epilepsy or dementia; 9. According to the researcher's judgment, there is a serious harm to the patient safety, or the impact of patients with the completion of the study of concomitant diseases; 10. Participated in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 year progression-free suvival;Complete remission rate;Partial remission rate;1 year overall survival; | — |
Countries
China