Status:
UNKNOWN
Efficacy and Safety of CsA+AVA in the Treatment of NSAA in the Elderly
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Aplastic Anemia
Eligibility:
All Genders
60-90 years
Phase:
PHASE2
Brief Summary
For elderly patients who cannot tolerate anti-thymocyte globulin (ATG) treatment, the addition of avatrombopag (AVA), which has a slight adverse reaction, can theoretically improve the hematological r...
Detailed Description
Aplastic anemia (AA) can be divided into severe AA (SAA) and non-severe AA (NSAA), according to the severity of the disease. Anti-thymocyte globulin (ATG) in combination with CsA is the most typical c...
Eligibility Criteria
Inclusion
- Elderly patients with well-defined NSAA anemia who meet the diagnostic criteria for aplastic anemia (AA) but do not meet the diagnostic criteria for severe aplastic anemia (SAA).
- Age 60 years or older, male or female.
- Able to swallow or administer orally.
- Intolerant or refused anti-thymocyte globulin treatment
- 6\. No previous treatment with cyclosporine, tacrolimus or hormones or treatment for less than 1 month.
- 7\. No prior treatment with thrombopoietin (TPO) receptor agonists (including eltrombopag, herombopag, romiplostim, etc.) 8. Informed consent must be signed before the start of all specific research procedures. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease, the informed consent shall be signed by the patient's immediate family.
Exclusion
- Known congenital AA (such as Fanconi anemia) and other causes of pancytopenia and hematological bone marrow disorders;
- With paroxysmal nocturnal hemoglobinuria (PNH) clone ≥ 50%
- With a history of hematopoietic stem cell transplantation.
- History of thrombosis
- Patients with underlying cancer who also have malignant tumors or are receiving immunosuppressive therapy.
- Baseline creatine levels greater than twice of the upper limit of normal (ULN) and/or alanine aminotransferase (ALT) greater than 2.5 times of the ULN;
- Serious heart, liver and kidney disease.
- With uncontrolled bleeding and/or infection after standard treatment.
- Participants considered unsuitable for inclusion by the researchers.
Key Trial Info
Start Date :
August 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06004752
Start Date
August 17 2023
End Date
August 1 2025
Last Update
December 8 2023
Active Locations (1)
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1
Peking union medical college hospital
Beijing, China