Romiplostim N01 in Chemoradiotherapy-induced Aplastic Anemia
Starting soon · Phase 2
Conditions studied: Aplastic Anemia
In brief
This study aimed to explore the efficacy and safety of romiplostim N01 in the treatment of chemoradiotherapy-induced aplastic anemia (AA)
Key facts
- Study ID
- NCT07572084
- Run by
- Peking Union Medical College Hospital
- People needed
- 43
- Starts
- 2026-04-01
- Expected to finish
- 2029-12-01
- Last updated by the study team
- 2026-05-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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.
Full record on ClinicalTrials.gov
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