Status:
UNKNOWN
Efficacy and Safety of CSA and Avatrombopag for the Treatment of SAA in the Elderly
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Severe Aplastic Anemia
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
This is a multicenter, single-arm clinical study. The objective was to evaluate the efficacy and safety of CSA in combination with Avatrombopag in elderly patients with very/sever aplastic anemia trea...
Detailed Description
This is a multicenter, single-arm clinical study to evaluate the efficacy and safety of CSA combined with Avatrombopag. The patients are older than 60 years with diagnosis of very sever/sever aplastic...
Eligibility Criteria
Inclusion
- elderly patients with V/SAA with a definite diagnosis.
- age greater than 60 years, male or female.
- Subjects must complete all screening assessments as outlined in the trial protocol.
- Able to swallow or administer the drug orally.
- Cannot tolerate or refuse ATG therapy.
- No prior treatment with cyclosporine, tacrolimus or hormones or treatment for no more than 2 weeks.
- No prior application of TPO receptor agonists (including Thrombopoietin, Eltrombopag, Hetrombopag, etc.) or application of TPO receptor agonists for treatment with ≤ 5 total doses and ≤ 7 days of TPO receptor agonist drugs such as Eltrombopag, Hetrombopag, etc.
- Informed consent must be signed prior to the start of all specific study procedures, in consideration of the patient's condition, or by a member of the patient's immediate family if the patient's signature is not conducive to the treatment of the condition.
Exclusion
- No subject shall be enrolled in this study if he/she meets any of the following criteria.
- known diagnosis of congenital hematopoietic failure disorders (e.g. Fanconi anemia) and other causes of allogeneic cytopenias and bone marrow hypoproliferative disorders (e.g. hemolytic PNH, hypoproliferative MDS/AML, autoantibody-mediated allogeneic cytopenias, etc.);
- Patients with uncontrolled bleeding and/or infection despite standard treatment.
- patients with previous history of hematopoietic stem cell transplantation;
- previous history of thrombosis.
- Patients with concurrent malignancy or potential cancer on immunosuppressive therapy.
- Those who are considered unsuitable for enrollment by the investigator.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05433922
Start Date
June 1 2022
End Date
December 31 2024
Last Update
June 27 2022
Active Locations (1)
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1
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020