Luspatercept Plus CsA vs CsA for the Treatment of Newly Diagnosed Non-Transfusion-Dependent NSAA
Megadott ok: This is a duplicate registration. The research plan and content have already been updated in another entry.
A legfontosabb adatok
- Fázis
- 4. fázis
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A vizsgálat adatai
- Ki végzi
- Peking Union Medical College Hospital
- Azonosító
- NCT06424639
- A regiszteradat frissítve
- 2026. június 4.
- Eredeti leírás
In a randomized, controlled clinical trial, the efficacy and safety of rodsipil combined with cyclosporine versus cyclosporine alone in the treatment of newly diagnosed non-transfusion-dependent NSAA were compared.A teljes eredeti leírásKevesebb
A Randomized, Controlled Trial Comparing the Safety and Efficacy of Luspatercept Plus Cyclosporine Versus Cyclosporine Alone for the Treatment of Newly Diagnosed Non-transfusion-dependent Non-severe Aplastic Anemia (NSAA)
In a randomized, controlled clinical trial, the efficacy and safety of rodsipil combined with cyclosporine versus cyclosporine alone in the treatment of newly diagnosed non-transfusion-dependent NSAA were compared.
Bevonási feltételek: Age ≥ 18 years; Hemoglobin level of 6-10 g/dL; Definition of NSAA: Patients with AA diagnosis but not SAA or VSAA diagnosis (at least two of the following conditions can be diagnosed as AA: (i) Hemoglobin < 100 g/L; (ii) Platelet count < 50×10\^9/L; (iii) Neutrophil count < 1.5×10\^9/L. SAA diagnosis criteria include less than 25% (or 25-50%, but residual hematopoietic cells < 30%) of bone marrow cells, plus at least two of the following conditions: (i) Neutrophil count < 0.5×10\^9/L; (ii) Platelet count < 20×10\^9/L; (iii) Retroperitoneal lymph node count < 20×10\^9/L. VSAA meets the criteria for SAA, but with neutrophil count < 0.2×10\^9/L. (British guidelines, 2015)); No active infection; No other concurrent neoplasms (except in situ carcinoma); Baseline liver and renal function within 1.5 times of normal value; No pregnancy or breastfeeding; Agree to sign informed consent form; Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Kizáró feltételek: Previous use of alemtuzumab, any ATG, or any dose of cyclosporine for immunosuppressive treatment; Previous hematopoietic stem cell transplant (HSCT); Any malignant tumor within 5 years, except local basal cell carcinoma; previous thromboembolic event, history of myocardial infarction or stroke (including antiphospholipid syndrome); currently using anticoagulants; Cytogenetic evidence of clonal hematological myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML); Uncontrolled infection or bleeding under standard treatment; Allergy to rituximab, cyclosporine, or excipients; History of allergy to polyethylene glycol (PEG) 80; Active infection or cirrhosis of the liver or portal hypertension due to HIV, HCV, or HBV; Screening QTcF (Fridericia QT corrected formula) less than 450 milliseconds or less than 480 milliseconds of bundle branch block determined by three ECG averages, and assessed on-site; unstable angina; uncontrolled hypertension (>180/100 mmHg); pulmonary hypertension; Congenital aplastic anemia; Presence of chromosomal aberrations; PNH clone ≥50%; Pregnant or lactating women; Participated in another clinical trial within 3 months.