aplastic anemia
Conditions
Interventions
Treatment Group:Treatment with a dose of ropromostim 10 µg/kg combined with cyclosporine 5 mg/kg/d was received
Sponsors
The First Affiliated Hospital of Zhejiang Chinese Medical University(Zhejiang Provincial Hospital of Chinese Medicine)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Inclusion criteria
Inclusion criteria: To be eligible for inclusion in this study, patients must meet the following criteria: (1)Age>=16 years; (2)Diagnosed with non-severe aplastic anemia (NSAA) according to the Chinese Guidelines for Diagnosis and Treatment of Aplastic Anemia (2022 edition) based on blood cell count, bone marrow examination, and cytogenetic analysis prior to enrollment; (3)ECG showing a QT interval < 460 ms; (4)ECOG performance status of 0-2; (5)Normal liver and kidney function (creatinine <=1.5 mg/dL, BUN <=1.5 mg/dL, SGPT <=2×ULN); (6)The subject must sign an informed consent form; (7)Patients who have previously received treatment with eltrombopag, avatrombopag, or other TPO-RAs may be enrolled after a one-month washout period.
Exclusion criteria
Exclusion criteria: If the patient meets any of the following criteria, they are excluded from participating in this study: (1)Patients with a recent plan to undergo hematopoietic stem cell transplantation; (2)Participation in another clinical trial within the past 30 days; (3)A history of malignancy with treatment for this malignancy within the past 3 years, excluding superficial bladder cancer, basal cell or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia (CIN), or prostatic intraepithelial neoplasia (PIN); (4)Active viral or bacterial infection that has not been controlled with appropriate anti-infective therapy; (5)Known seropositivity for HIV or active hepatitis C virus; (6)Mental disorders or other conditions that would preclude compliance with the study treatment and monitoring requirements; (7)Patients with uncontrolled heart disease; (8)Pregnant patients or patients unable to use adequate contraception during the treatment period; (9)Bone marrow aplasia; (10)Known allergy to any component of romiplostim; (11)A history of thrombosis; (12)Use of eltrombopag, avatrombopag, or other TPO-RAs within the past month, or hematopoietic stem cell transplantation within the past year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Blood Count ;overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Peripheral Blood Stem Cell Count ;Reticulocyte Count;Bone Marrow Smear Morphology;Bone Marrow Karyotype;Detection of aplastic anemia-Associated Mutant Genes;Bone Marrow Pathology;Biochemical Tests;Bone Marrow Microenvironment Detection;Telomerase Detection;paroxysmal nocturnal hemoglobinuria(PNH) Clone Detection;Detection of Lymphocyte Subpopulations;Cytokines; | — |
Countries
China
Contacts
Public ContactBaodong Ye
The First Affiliated Hospital of Zhejiang Chinese Medical University(Zhejiang Provincial Hospital of Chinese Medicine)
Outcome results
None listed