Study of Dose-Reduced Immunosuppressive Therapy and Hetrombopag for Elderly Patients 65 or Older With Severe or Very Severe Aplastic Anemia

What this Trial Is About

Researchers are conducting a prospective, single-center, single-arm, open-label Phase IIB clinical trial to evaluate the safety and effectiveness of dose-attenuated immunosuppressive therapy IST combined with Hetrombopag in elderly patients aged 65 years or older diagnosed with very severe aplastic anemia VSAA or severe aplastic anemia SAA. This study focuses on this older population to better understand treatment options for these serious blood disorders. The treatment involves receiving Porcine antithymocyte globulin P-ATG intravenously at 15 mgkg per day for 5 days, along with oral cyclosporine at 3 to 5 mgkg per day adjusted to maintain specific blood levels, and Hetrombopag at 15 mg daily for 24 weeks. Participants will be monitored weekly for 24 weeks, including a bone marrow evaluation at the end of this period to assess response. During the study, participants will undergo regular follow-up visits each week for six months to track their blood health and treatment effects. Researchers will measure the hematologic response rate at 24 weeks after treatment and monitor early mortality at 12 weeks. The study also observes complete response rates at 24 weeks. Safety and efficacy will be carefully assessed throughout the study to understand how well this treatment approach works in elderly patients.

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