Romiplostim N01 in Chemoradiotherapy-induced Aplastic Anemia

Inclusion criteria

• 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;

Exclusion criteria

• 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.