low and intermediate risk myelodysplastic syndromes
Conditions
Interventions
Experimental group:Romiplostim N01 (250 µg, subcutaneous injection, once weekly) and Azacitidine (75 mg/m2, subcutaneous injection, Days 1-7).
Sponsors
Fujian Provincial Hospital Affiliated to Fuzhou University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Diagnosed with myelodysplastic syndromes (MDS) via bone marrow biopsy according to the World Health Organization (WHO) classification, with a platelet count = 18 years. 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2. 5. Voluntarily accept bone marrow aspiration and biopsy, peripheral blood tests, cytogenetic analysis or fluorescence in situ hybridization (FISH) detection. 6. No contraindications to treatment with Azacitidine and Romiplostim N01. 7. Adequate hepatic and renal function: alanine transaminase (ALT) and aspartate transaminase (AST) 50 mL/min (calculated using the Cockcroft-Gault formula). 8. Plan to receive subcutaneous injection of Azacitidine at 75 mg/m² daily for 7 consecutive days per cycle, for a minimum of 4 cycles. 9. The subjects must be fully informed of this study prior to enrollment, voluntarily sign the written informed consent form, and be willing and able to comply with study visits, treatment regimens, laboratory tests and other study procedures.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with myelofibrosis via bone marrow biopsy. 2. Patients with a history of symptomatic venous thromboembolic events (e.g., deep vein thrombosis or pulmonary embolism) or symptomatic arterial thrombotic events (e.g., myocardial infarction, ischemic stroke or transient ischemic attack), or those intolerant to anticoagulant therapy. 3. Patients who received more than 6 cycles of hypomethylating agents for MDS without response, as defined by the International Working Group (IWG) criteria for MDS. Prior use of non-peptide thrombopoietin receptor agonists (TPO-RA) such as lusutrombopag and eltrombopag, or recombinant human thrombopoietin (rhTPO) for MDS is permitted. 4. Prior diagnosis of high-risk MDS assessed per the International Prognostic Scoring System (IPSS). 5. History of leukemia, aplastic anemia or other hematopoietic stem cell diseases unrelated to MDS. 6. Prior allogeneic bone marrow transplantation. 7. Presence of other active malignancies within the past 3 years, except for curatively treated early-stage malignancies (carcinoma in situ or Stage I tumors), such as adequately treated cervical carcinoma in situ, thyroid cancer, basal cell carcinoma or squamous cell carcinoma of the skin. 8. Active or uncontrolled infections. 9. Unstable angina, congestive heart failure (New York Heart Association functional class > Class II), uncontrolled hypertension (diastolic blood pressure > 100 mmHg), uncontrolled arrhythmia, or myocardial infarction occurring within 1 year prior to enrollment. 10. Administration of interleukin-11 (IL-11), granulocyte colony-stimulating factor (G-CSF), pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 4 weeks before enrollment or planned use after the first study drug administration. 11. Known allergy to any component of the study drugs or any Escherichia coli-derived products; patients with multiple drug allergies or severe allergic diseases. 12. Treatment with any other investigational drugs or participation in another investigational drug trial within 28 days prior to enrollment. 13. Known history of psychiatric disorders, drug abuse, alcoholism or illicit drug use. 14. Pregnant or breastfeeding females. 15. Women of childbearing potential who fail to use adequate contraception during the study and within 15 days after the last dose of study drug. 16. Other patients deemed ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete or major platelet response rate within 4 cycles;Incidence rate of adverse drug reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of weeks where the platelet response is =50% in patients treated with Romiplostim;Health-related Quality of Life Score (SF-36); | — |
Countries
China
Contacts
Public ContactWang Zhihong
Fujian Provincial Hospital Affiliated to Fuzhou University
Outcome results
None listed