very poor, poor or intermediate risk IPSS-R myelodysplastic syndrome
Conditions
Interventions
Test group:Accepting luspatercept combined with androgen
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subject is = 18 years of age the time of signing the informed consent form 2. The diagnosis of myelodysplastic syndrome (MDS) according to The 2016 WHO classification and diagnostic criteria for myeloproliferative neoplasms was consistent with the International Prognostic Score System-Revised (IPSS-R) classification of very poor, poor or intermediate risk diseases, bone marrow primordial cells < 5%. 3. Endogenous serum erythropoietin (sEPO) level < 500U/L. 4. Red blood cell transfusion is required, as stated in the standard: the average transfusion of 6-8 IU / 8-week packed red blood cell (pRBC) was demanded before random grouping at least 2 weeks. 5.WHO Eastern Cooperative Oncology Group score is 0, 1 or 2. 6. Informed consent has been signed. The informed consent form shall be signed by the patient or the immediate family member. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease, the informed consent form shall be signed by the legal guardian or the immediate family members.
Exclusion criteria
Exclusion criteria: 1. Anemia caused by deficiency of iron, vitamin B12 or folic acid , and autoimmune hemolytic, hereditary hemolytic, hypothyroidism or any type of known clinically bleeding, drug-induced anemia. 2. Known diagnostic history of acute myeloid leukemia (AML). 3. Uncontrolled hypertension, which defined as repeated in systolic blood pressure (SBP) = 150mmHg and / or diastolic blood pressure (DBP) = 100mmHg despite adequate treatment. 4. Patients with malignant tumors of other organs. 5. Accept any other drug research within 30 days after taking the research drug for the first time. 6. Uncontrolled concomitant diseases, including, but not limited to, persistent or active infections, NYHA class III or IV congestive heart failure, unstable angina, arrhythmia or mental illness. 7. Radiotherapy was accpted within 14 days before the study was enrolled. 8. Exclude pregnant women or breast-fed women. 9. According to the protocol or the judgment of the researchers, patients with severe physical or mental illness may interfere their participation in this clinical study. 10. Drug abuse,conditions of medical, psychological or social that may interfere with subjects' participation or research results. 11. Patients who are receiving other experimental drugs. 12. Researchers consider that participants are not suitable for enrollment. 13. The researchers consider that the criteria for exclusion due to scientific reasons, compliance reasons, or subjects' safety reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Red blood cell transfusion independence (RBC-TI); | — |
Secondary
| Measure | Time frame |
|---|---|
| mean corpuscular hemoglobin concentration;Red blood cell transfusion independence (RBC-TI)=12 weeks;RBC-TI time;The unit of red blood cell (RBC) reduction;Serum ferritin;The average reduction time of iron chelation therapy (ICT) use;Serum erythropoietin concentration;Reticulocyte count (%);The incidence of adverse event types (AE);The incidence of AE severity;The incidence of adverse events in relation to treatment;Overall survival;Number of participants who progress to acute myeloid leukemia (AML);Percentage of participants who progress to AML;Time to progress to AML; | — |
Countries
China
Contacts
Public ContactGe Jian
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed