Severe aplastic anemia
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| CR rate at 12 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects and clonal transformation;Response to treatment; | — |
Countries
China
Contacts
National Clinical Research Center for Blood Diseases, Institute of Hematology & Blood Diseases Hospital