Myelodysplastic syndrome
Conditions
Interventions
Experimental Group:The dose of Luspatercept was 1.0 mg/kg once every 3 weeks.The dose of azacitidine is 75 mg/m2/d × 7 d, subcutaneous injection, and one course of treatment is every 4 weeks.
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria 1) Patients who meet the WHO (5th edition) MDS diagnostic criteria and are classified as medium-to-high risk (IPSS-R>3 points) by the International Prognostic Scoring System (IPSS) and the revised IPSS (IPSS-R). 2) ECOG score <3 points and age 18-75 years (including 18 and 75 years old) 3) Bone marrow morphology indicates active bone marrow proliferation 4) Normal liver and kidney function, blood bilirubin <=35µmol/L, AST/ALT below 2 times the upper limit of normal value, blood creatinine <=150µmol/L 5) Normal heart function 6) Obtain informed consent signed by the patient or family members
Exclusion criteria
Exclusion criteria: 2. Exclusion criteria 1) Patients who have transformed into acute myeloid leukemia 2) Patients with obvious liver and kidney function abnormalities exceeding the inclusion criteria 3) Severe heart disease, including myocardial infarction and heart failure 4) ECG results: QT interval greater than 450 milliseconds 5) Patients with other organ malignancies at the same time 6) Active tuberculosis patients and HIV-positive patients 7) Pregnant or lactating women 8) Allergic to or obvious contraindications to any drug involved in the protocol 9) Patients with ECOG>=3, CCI>1 (comorbidity index), ADL<100 (daily life scale) 10) Unable to understand or comply with the study protocol 11) Previous history of intolerance or allergy to similar drugs 12) MDS patients under 18 years old or over 75 years old (excluding 18 and 75 years old) 13) Participating in other clinical researchers at the same time 14) Any other situation that hinders the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate in bone marrow;Red blood cell transfusion independence >= 8 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Partial response rate;Complete remission in bone marrow;Cytogenetic complete remission rate;Disease-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactWU YU
West China Hospital, Sichuan University
Outcome results
None listed