Not Yet RecruitingPhase 2

Romiplostim N01 in Chemoradiotherapy-induced Aplastic Anemia

43 participantsStarted 2026-04

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

ORR (Overall Response Rate)

Timeframe: 3-month, 6-month

NCT IDNCT07572084

SponsorPeking Union Medical College Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12

Bing Han

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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