Efficacy and Safety of CSA and Avatrombopag for the Treatment of SAA in the Elderly (NCT05433922) | Clinical Trial Compass
UnknownNot Applicable
Efficacy and Safety of CSA and Avatrombopag for the Treatment of SAA in the Elderly
China80 participantsStarted 2022-06-01
Plain-language 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 treated for the first time. The design was: cyclosporine 3 mg/kg orally in two divided doses, with cyclosporine trough concentrations maintained at 200-250 ng/ml for 3 months to achieve maximum efficacy, and Avatrombopag, which was administered in two dose groups, 40 mg orally once daily and 60 mg orally once daily, for a total of 24 weeks. Forty patients are expected to be enrolled in each dose group, and a total of 80 patients are expected to be enrolled if both dose groups are conducted. Evaluation endpoint: OR rate at 24 weeks of treatment.
Who can participate
Age range60 Years
SexALL
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Inclusion criteria
✓. 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 criteria
What they're measuring
1
OR rate at 24 weeks of treatment
Timeframe: 24 weeks of treatment
2
Incidence of Treatment-Emergent Adverse Events as assessed by information on Common Toxicity Criteria (CTC) AE grading at 24 weeks of treatment
Timeframe: 24 weeks of treatment
3
Percentage of patients with transformation at 24 weeks
Timeframe: 24 weeks of treatment
Trial details
NCT IDNCT05433922
SponsorInstitute of Hematology & Blood Diseases Hospital, China
. 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.