MDS
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) MDS defined by WHO2016 (see appendix 2); 2) aged >18 years old; 3) ipss-r rating medium, high risk and very high risk MDS (see appendix 3); 4) any HI that did not meet IWG2006 standards or developed disease progression for 4 cycles with the 20mg/m2/ dx5-day regimen of desitabine and/or was subsequently treated with only the best supportive therapy, allowing dose adjustments according to the instructions; 5) ECOG score 2 or less; 6) transplant or not; 7) women of childbearing age volunteered to use contraception and at least one effective contraceptive method during the study period; 8) male patients voluntarily avoided getting their partners pregnant and used at least one effective contraceptive method during the study period; 9) full liver and kidney functions: serum bilirubin <=1.5 times the upper normal value (ULN), AST<=2.0 ULN, ALT<=2.0 ULN, and serum creatinine <=1.5 ULN.
Exclusion criteria
Exclusion criteria: 1) patients who are known to be allergic to azarcytidine or mannitol; 2) previous use of azarcytidine for treatment; 3) malignancies diagnosed within the first 12 months of the study (except basal cell carcinoma, cervical or breast carcinoma in situ, and other tumors considered highly curable); 4) pregnant or lactating women; 5) patients with advanced malignant liver tumors; 6) other conditions deemed inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ny HI defined by IWG2006; | — |
Countries
China
Contacts
Sun Yat-sen University Cancer Center