Romiplostim N01 in the Treatment of Refractory Chemoradiotherapy-induced AA
Reason given: The registration of this research plan was incorrect. A new registration has been done.
Key facts
- Phase
- Phase 2
Trial details
- Who runs it
- Peking Union Medical College Hospital
- Trial code
- NCT07532408
- Record updated
- 4 June 2026
- Original description
This study aimed to explore the efficacy and safety of romiplostim N01 in the treatment of relapsed/refractory chemoradiotherapy-induced aplastic anemiaRead full original descriptionShow less
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
Inclusion: 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.
Exclusion: 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.