Romiplostim N01 in the Treatment of Refractory Chemoradiotherapy-induced Aplastic Anemia: a Single-center, Prospective, Open-label Study

Peking Union Medical College Hospital0 个研究点目标入组 43 人开始时间: 2026年4月1日最近更新: 2026年5月7日

适应症

试验速览

This study aimed to explore the efficacy and safety of romiplostim N01 in the treatment of chemoradiotherapy-induced aplastic anemia (AA)

•Age ≥ 18 years old;
•Diagnosed with relapsed/refractory chemoradiotherapy-induced 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 upper limit of normal (ULN);
•Without active infection that cannot be controlled by standard treatment;
•Signed the informed consent;
•ECOG score ≤ 2;

•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;
•Paroxysmal nocturnal hemoglobinuria (PNH) clone ≥ 50%;
•Received hematopoietic stem cell transplantation before enrollment;
•Received ATG treatment before enrollment;
•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;
•Pregnant or lactating patients;
•Participated in other clinical trials within 3 months.

发起方

申办方类型

Other

责任方

Principal Investigator

主要研究者

Bing Han

Professor

Peking Union Medical College Hospital