Health Trials

CsA+EPAG/HPAG+Romiplostim N01 in Newly-diagnosed SAA/TD-NSAA

ConditionsSevere Aplastic Anemia (SAA)Transfusion-dependent Non-severe Aplastic 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 cyclosporine (CsA)

+eltrombopag (EPAG)/hetrombopag (HPAG)+romiplostim N01 in the treatment of newly-diagnosed transfusion-dependent aplastic anemia (TD-NSAA) and severe aplastic anemia (SAA)

Eligibility criteria

Qualifiers

Age ≥ 18 years old;

Diagnosed with aplastic anemia (AA) through routine blood tests, bone marrow puncture, bone marrow biopsy, and exclusion tests, and determined as transfusion-dependent non-severe aplastic anemia (TD-NSAA) or severe aplastic anemia (SAA) according to the Camitta criteria; Platelet < 30×10^9/L;

Had no HLA-matched donors or was not suitable for first-line allogeneic hematopoietic stem cell transplantation (HSCT);

Not suitable for ATG, due to reasons such as age, complications, and the patient's own wishes;

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;

PNH clone ≥ 50%;

Received HSCT before enrollment;

Trial design

Treatments tested in this trial

  • Cyclosporine (CsA)
  • thrombopoietin receptor agonist (TPO-RA)
  • Romiplostim N01

Treatment groups

43 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Peking Union Medical College Hospital

Lead sponsor

Source ClinicalTrials.gov