Reduced Dose of Cyclophosphamide Combined With Standard Immunosuppressive Therapy to Treat Severe Aplastic Anemia

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

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

Treatment groups

75 Participants
are divided into 1 treatment group