Romiplostim N01 in Chemoradiotherapy-induced Aplastic Anemia
ConditionAplastic Anemia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital
About this trial
This study aimed to explore the efficacy and safety of romiplostim N01 in the treatment of chemoradiotherapy-induced aplastic anemia (AA)
Eligibility criteria
Qualifiers
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);
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Romiplostim N01
Treatment groups
43 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov