Overview
This prospective, single center, single-arm study aims to evaluate the efficacy and safety of anti-human T lymphocyte porcine immunoglobulin (p-ALG) in combination with cyclosporine and Romiplostim in treating severe aplastic anemia (SAA). It will include 48 patients with newly diagnosed SAA.
Eligibility
Inclusion Criteria:
- Age ≥ 12 years
- Diagnosis of severe or very severe aplastic anemia
- Patients are unconditionally or unacceptable undergoing allogeneic hematopoietic stem cell transplantation
- ECOG performance status ≤2
- Willing and able to comply with the requirements for this study and written informed consent.
Exclusion Criteria:
- Received > 4 weeks of TPO-RA drug before treatment
- Received > 4 weeks of immunosuppressive therapy before treatment
- History of thromboembolic disease
- Intolerance to Romiplostim N01 or cyclosporine
- Allergy to ALG
- Presence of uncontrolled active infection
- Presence of uncontrolled hypertension (≥140/90mmHg), diabetes mellitus (fasting blood glucose≥ 7.0 mmol/L or random blood glucose ≥ 11.1 mmol/L)
- Abnormal liver and kidney function: Aspartate Transaminase (AST) or Alanine Transaminase (ALT) > 3 ULN, creatinine ≥ 2.5 ULN
- History of chemoradiotherapy for malignant solid tumors
- History of other systemic serious illnesses
- Females who are pregnant/lactating or need pregnancy
- Patients considered to be ineligible for the study by the investigator for reasons other than the above