Standard Immunosuppressive Therapy Combined With Romiplostim N01 as First-line Treatment for Severe Aplastic Anemia
Trial Parameters
Brief Summary
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 Criteria
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