Myelodysplastic syndrome
Conditions
Interventions
Group 1:Decitabine
Group 2:Azacitidine
Sponsors
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Meet the diagnostic criteria of MDS (2008), the IPSS (international prognostic score) was classified as intermediate-2 risk, high-risk and refractory MDS patients; 2) Age between 18 and 80 years; 3) No differentiation inducing drugs were used within the first three months of inclusion, such as all-transretinoic acid, valproic acid and arsenic trioxide in the past three months; 4) ECOG score 0-2; 5) Creatinine <=1.5 ULN, BUN<=1.5 ULN, ALT<=2 ULN, AST<=2 ULN, Tbil<=1.5 ULN; 6) Patients were treated by cell stimulating factor therapy in the past, Stop using cell stimulating factor therapy at least a month before joining the study; 7) Accurate past history and treatment history (including blood transfusion, and hemoglobin measure) in the past 8 weeks before joining the study; 8) The patient or family members understand and voluntarily signed informed consent.
Exclusion criteria
Exclusion criteria: 1) In recent 30 days, patients received other study drug therapy; 2) 5q-syndromes; 3) Patients with a history of tumor and have received any treatment for this tumor in the past 3 years, except for superficial bladder cancer, basal cell or squamous cell carcinoma of the skin, cervical intraepithelial carcinoma (CIN) or prostate intraepithelial carcinoma (PIN); 4) Patients have active viral or bacterial infections, and failure to use appropriate anti-infection treatment; 5) Patients with mental disorders or other condition and cannot cooperate research treatment and monitoring requirements; 6) Pregnancy (Women of childbearing age need to undergo pregnancy tests) and lactation; 7) HIV positive and active hepatitis patients are excluded in this study; 8) Researchers think unfavorable patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| FOXO1 gene expression;Immune gene expression; | — |
Countries
China
Contacts
Public ContactZhang Zheng
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Outcome results
None listed