Not yet recruiting NCT07572084

Romiplostim N01 in Chemoradiotherapy-induced Aplastic Anemia

Phase II Interventional Aplastic Anemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Romiplostim N01.
Who it may be relevant to: Registry conditions: Aplastic Anemia. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

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 chemoradiotherapy-induced aplastic anemia (AA)

Drug Romiplostim N01
Romiplostim N01 20 µg/kg subcutaneously once a week for at least 3 months

Secondary outcome measures (4)

CRR [Time frame: 3-month, 6-month]
Adverse event (AE) rate [Time frame: through study completion, an average of 1 year]
Predictive factors for ORR or CRR [Time frame: 3-month]
Clonal evolution rate [Time frame: through study completion, an average of 1 year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Center list to be confirmed — check the primary protocol.

NCT: NCT07572084 · K10498