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A multicenter, single-arm clinical study of the early efficacy and safety of IST combined with Avatripopa in the treatment of elderly patients with severe aplastic anemia

A multicenter, single-arm clinical study of the early efficacy and safety of IST combined with Avatripopa in the treatment of elderly patients with severe aplastic anemia

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061174
Enrollment
Unknown
Registered
2022-06-15
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe aplastic anemia

Interventions

2:Avatrippa

Sponsors

National Clinical Research Center for Blood Diseases, Institute of Hematology & Blood Diseases Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Elderly patients with clearly diagnosed severe or severe aplastic anemia; 2. Age >= 60, male or female 3. Subjects must complete all screening evaluations listed in the study protocol; 4. Able to swallow or administer orally; 5. No prior ATG treatment; 6. No previous treatment with cyclosporine, tacrolimus or hormones or treatment for less than 2 weeks; 7. No TPO receptor agonists (including thrombocytophysin, altrepopa, hetrepopa, etc.) or the total dose of Tpo was less than 5; TPO receptor agonists such as Altrepopa, Viropopa, avtrepopa were less than 7 days; 8. Informed consent must be signed before the start of all specific study procedures. Considering the patient's condition, if the patient's signature is not conducive to treatment, the informed consent shall be signed by the patient's immediate relatives.

Exclusion criteria

Exclusion criteria: Exclusion criteria: Subjects who meet any of the following criteria will not be included in this study: 1. Pancytopenia caused by known diagnosed congenital hematopoietic disorders (e.g. Fanconi anemia) and other causes, as well as bone marrow hypoproliferative diseases (e.g. Hemolytic PNH, hypoproliferative MDS/AML, autoantibody mediated pancytopenia, etc.); 2. Patients with bleeding and/or infection that cannot be controlled after standard treatment; 3. Patients with previous history of hematopoietic stem cell transplantation; 4. Previous history of thrombosis; 5. Patients with potential cancer or receiving immunosuppressive therapy at potential cancer risk; 6. Life Functioning status (ECOG) score reached or exceeded 3; Charlson comorbidity score system over 4 points; 7. The researcher considered those who were not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
CR rate at 12 weeks of treatment;

Secondary

MeasureTime frame
Side effects and clonal transformation;Response to treatment;

Countries

China

Contacts

Public ContactLi Zhang

National Clinical Research Center for Blood Diseases, Institute of Hematology & Blood Diseases Hospital

zhangli@ihcams.ac.cn+86 18630803077

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026