Lower-dose immunosuppression plus hetrombopag for severe aplastic anemia in people 65 and older

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center, single-arm, open-label Phase IIB trial testing dose-attenuated immunosuppressive therapy (IST) combined with hetrombopag in patients aged 65 or older with very severe or severe aplastic anemia. Treatment consists of P-ATG 15 mg/kg IV daily for 5 days, cyclosporine 3 mg/kg/day adjusted to trough levels of 100–200 μg/L, and hetrombopag 15 mg daily. Participants are followed weekly for 24 weeks with a bone marrow evaluation at week 24 to document hematologic response and monitor safety. Key eligibility excludes clonal cytogenetic abnormalities (except isolated -Y or +8), prior ATG/high-dose cyclophosphamide, prolonged prior calcineurin inhibitor or TPO-RA use, uncontrolled malignancy, or severe organ dysfunction.

Why it matters

Who can join: the full rules

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.

Where it's running

• Red Blood Cell Diseases Center
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Principal investigator: Jun Shi, PhD — Institute of Hematology & Blood Diseases Hospital, CAMS
• Study coordinator: Jianping Li, MD
• Email: lijianping@ihcams.ac.cn
• Phone: +8613820961539

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.