Myelodysplastic syndromes
Conditions
Interventions
Azacitidine Combined with Luspatercept Group:N/A
Sponsors
Beijing No.6 Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Diagnosis & Risk Stratification: Age >=18 years, confirmed MDS via bone marrow aspiration, classified as very low/low/intermediate risk (IPSS-R score<=3.5) per IPSS-R. 2.Organ Function: Normal hepatic/renal function (lab values<=2×ULN); tolerable to treatment and compliant with follow-up. 3.Informed Consent: Capacity to understand and provide written informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Active infection requiring systemic anti-infective therapy that is difficult to control in the short term. 2. Concomitant other active malignancies or requiring anti-tumor therapy. 3. Significant abnormalities in hepatic or renal function, or insufficiency of vital organ function, judged by the investigator as unsuitable for enrollment. 4. Pregnant or lactating females, or those planning pregnancy during the study period. 5. Known hypersensitivity to azacitidine or luspatercept or their excipients. 6. Refusal or inability to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of RBC transfusion independence (RBC-TI) for >=12 weeks within Weeks 1-24 after treatment initiation, and mean hemoglobin increase >=15 g/L during the same period; | — |
Countries
China
Contacts
Public ContactZhang Juan
Beijing No.6 Hospital
Outcome results
None listed