Dose-attenuated IST and Hetrombopag in Elderly (≥65 Years) Patients With Severe Aplastic Anemia
Dose-attenuated IST and Hetrombopag in the Treatment of Elderly (≥65 Years) Patients With Very Severe/Severe Aplastic Anemia: A Single-Center, Single-Arm, Phase IIB Clinical Study on Efficacy and Safety
Institute of Hematology & Blood Diseases Hospital, China
65 participants
Feb 1, 2025
INTERVENTIONAL
Conditions
Summary
This is a prospetive,Single-Center, Single-Arm, Phase IIB Clinical Study.This study aims to evaluate the efficacy and safety of dose-attenuated IST combined with Hetrombopag in elderly patients (≥65 years) with VSAA/SAA.
Eligibility
Inclusion Criteria5
- 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 Criteria7
- 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.
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Interventions
Porcine-ATG : 15 mg/kg/day IV ×5 days. Cyclosporine : 3-5 mg/kg/day (adjusted to trough 100-200 μg/L). Hetrombopag: 15 mg daily for 24weeks.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07010237