About this trial
This is a prospective, single-center, single-arm, phase 2 study. This study aims to evaluate the efficacy and safety of anti-lymphocyte globulin plus herombopag in combination with the reduced dose of cyclophosphamide (hypo-CASH) for severe aplastic anemia.
Eligibility criteria
Qualifiers
Subject has a diagnosis of naïve severe or very severe aplastic anemia
Male or female age ≥ 12 years
Unwilling or unable to receive allogeneic hematopoietic stem cell transplantation.
ECOG performance status ≤2
Disqualifiers
Previously received immunosuppressive therapy > 4 weeks
Previously treated with TPO-RA > 4 weeks
Have an allergy or intolerance to anti-lymphocyte globulin, cyclosporine, herombopag or cyclophosphamide.
Uncontrolled fungal, bacterial, or viral infection. Hepatitis-associated aplastic anemia is allowed; hepatitis B or C infection is permitted unless it causes severe liver failure.
Trial design
Treatments tested in this trial
- Reduced dose of cyclophosphamide combined with standard immunosuppressive therapy