Romiplostim N01 in the Treatment of Refractory Chemoradiotherapy-induced AA
Megadott ok: The registration of this research plan was incorrect. A new registration has been done.
A legfontosabb adatok
- Fázis
- 2. fázis
A vizsgálat adatai
- Ki végzi
- Peking Union Medical College Hospital
- Azonosító
- NCT07532408
- A regiszteradat frissítve
- 2026. június 4.
- Eredeti leírás
This study aimed to explore the efficacy and safety of romiplostim N01 in the treatment of relapsed/refractory chemoradiotherapy-induced aplastic anemiaA teljes eredeti leírásKevesebb
Romiplostim N01 in the Treatment of Refractory Chemoradiotherapy-induced Aplastic Anemia: a Single-center, Prospective, Open-label Study
This study aimed to explore the efficacy and safety of romiplostim N01 in the treatment of relapsed/refractory chemoradiotherapy-induced aplastic anemia
Bevonási feltételek: Age ≥ 18 years old; Diagnosed with relapsed/refractory chemoradiotherapy-induced aplastic anemia (AA). Relapsed/ refractory was defined as patients who had no response to at least 3 months of cyclosporine or thrombopoietin receptor agonists (TPO-RAs) such as eltrombopag; At least one of the following conditions must be met: hemoglobin < 90 g/L, platelet count < 30×109/L, neutrophil count < 1.0×109/L; With baseline liver and kidney functions <2 ULN; Without active infection that cannot be controlled by standard treatment; Signed the informed consent; ECOG score ≤ 2.
Kizáró feltételek: Received HSCT before enrollment; Received ATG treatment before enrollment; Had other primary or secondary bone marrow failure (BMF) diseases, such as Fanconi anemia, congenital keratinization disorder, etc; With evidence of clonal hematological bone marrow diseases (MDS, AML) in cytogenetics; Severe bleeding or infection that cannot be controlled by standard treatment; Allergic or intolerant to romiplostim N01; Active infections of HIV, HCV, or HBV, liver cirrhosis, or portal hypertension; History of malignant tumors within 5 years; History of arterial or venous thrombosis; PNH clone ≥ 50%; Pregnant or lactating patients; Participated in other clinical trials within 3 months.