Dose-attenuated IST and Hetrombopag in Elderly (≥65 Years) Patients With Severe Aplastic Anemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dose-attenuated IST and Hetrombopag.
- Who it may be relevant to
- Registry conditions: Sever Aplastic Anaemia, Elderly (People Aged 65 or More), Immunosuppressive Treatment. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
Design : Prospective, single-center, single-arm, open-label Phase IIB trial.
Intervention :
P-ATG : 15 mg/kg/day IV ×5 days. Cyclosporine : 3 mg/kg/day (adjusted to trough 100-200 μg/L). Hetrombopag : 15 mg daily. Follow-Up : Weekly for 24 weeks, with bone marrow evaluation at 24 weeks.
Inclusion Criteria :
Confirmed diagnosis of VSAA/SAA. Age ≥65 years. Completion of all screening assessments. Ability to swallow oral medication. 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.
Interventions
- Drug Dose-attenuated IST and Hetrombopag
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.
Primary outcome measures
- Hematologic response rate at 24 weeks post-ATG treatment. [Time frame: 24 weeks]
Secondary outcome measures (2)
- Early mortality rate [Time frame: 12 weeks]
- Complete Response [Time frame: 24 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Red Blood Cell Diseases Center — Tianjin
Identifiers
NCT: NCT07010237 · IIT2025013