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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis of VSAA/SAA.

Age ≥65 years.

Completion of all screening assessments.

Must be able to swallow tablets.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Dose-attenuated IST and Hetrombopag

    Drug

    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.

Treatment groups

65 Participants
are divided into 1 treatment group
Group A: A-ISTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Hematologic response rate at 24 weeks post-ATG treatment.

PR+CR Partial Response (PR) : Independence from transfusions without meeting CR. No Response (NR) : Failure to achieve PR.

Time frame
24 weeks

Secondary outcomes

1

Early mortality rate

Early mortality rate within 12weeks

Time frame
12 weeks
2

Complete Response

Complete Response (CR) : HGB ≥100 g/L, PLT ≥100×10⁹/L, ANC ≥1.0×10⁹/L.

Time frame
24 weeks

Other outcomes

Sponsors and contacts

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