myelodysplastic syndrome
Conditions
Interventions
experimental group:decitabine combined with the best suportive treatment
control group:the best supportive treatment
Sponsors
1st Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adults more than 18 years of age; 2. Patients with a confirmed diagnosis of low and int-1 risk myelodysplastic syndrome; 3. IPSS scale <=1.0; 4. Patients with adequate performance status (ECOGroup scale: 0-2); 5. Adequate hepato-renal function (creatinine level less than 1.5*ULN, bilirubin level less than 50umol/L, ALT and AST less than 2.5*ULN); 6. Patients are required to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patient's liver and kidney function was abnormal beyond the inclusion criteria; 2. Patients have serious heart disease, including myocardial infarction, heart function grade 3-4; 3. Known HIV positive serological reaction; 4. Life expectancy is less than 3 months; 5. Patients had received treatment with Vidaza or decitabine, or had received stem cell transplantation; 6. Pregnant or lactating women; 7. Diagnosed with secondary MDS; 8. Participating in other clinical research in the same period, patients also have other organ malignant tumor; 9. the researchers estimate cannot enter group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hematological improvement rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall improvement rate;PFS;cytogenetic response;transfusion needs;the effect of time; | — |
Countries
China
Contacts
Public ContactHong-yan Tong
Outcome results
None listed