Dose-attenuated IST and Hetrombopag in Elderly (≥65 Years) Patients With Severe Aplastic Anemia

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Jun 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for elderly patients aged 65 and older who have severe aplastic anemia, a condition where the bone marrow doesn't produce enough blood cells. The researchers want to see if a combination of a lower dose of immunosuppressive therapy (IST) and a medication called Hetrombopag can help these patients feel better and be safe to use. The trial is currently looking for participants at a single center.

To be eligible for this study, patients must have a confirmed diagnosis of severe aplastic anemia and be at least 65 years old. They should be able to swallow tablets and must provide consent for participation. However, people with certain health issues, previous treatments that could interfere with the study, or specific genetic abnormalities will not be able to join. If someone decides to participate, they will be monitored closely throughout the study to ensure their safety and to see how well the treatment works.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Clinical diagnosis of VSAA/SAA.
• • Age ≥65 years.
• • Completion of all screening assessments.
• • Must be able to swallow tablets.
• • Signed informed consent (by patient or legal guardian if patient is incapacitated).
• Exclusion Criteria:
• • Clonal cytogenetic abnormalities (excluding isolated -Y or +8).
• • Prior treatment with ATG/high-dose cyclophosphamide.
• • Prior cyclosporine/tacrolimus use \>12 months.
• • Prior TPO-RA therapy \>3 months.
• • Uncontrolled malignancies or conditions contraindicating ATG.
• • Severe organ dysfunction (e.g., creatinine ≥177 μmol/L).
• • Investigator judgment of unsuitability.