Status:
UNKNOWN
Efficacy of IST Combined With TPO-RA in the Treatment of AA and Establishment of a Recurrence Prediction System
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Aplastic Anemia
CSA
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
In this study, investigators intend to prospectively study treatment-naive AA patients (including SAA and NSAA) who are non-transplant candidates in northern China. Patients with SAA receive ATG+CsA+H...
Detailed Description
1\) Patients in the SAA group: CsA: 3-5mg/kg/day, monitor the trough concentration every month, and maintain the trough concentration at 100-200ng/ml. ATG: rabbit anti-thymocyte immunoglobulin (r-ATG)...
Eligibility Criteria
Inclusion
- Age: 18-75 years old, gender is not limited
- Definite diagnosis of AA
- No HSCT indication or unconditional HSCT
- SAA/VSAA patients were willing to accept ATG+CsA+TPO-RA treatment, NSAA was willing to accept CsA+TPO-RA treatment, and were willing to follow up regularly
- Baseline serum transaminase, total bilirubin and serum creatinine were less than 1.5 times the normal value
- Baseline liver and kidney function was less than 1.5 times the normal value
- Eastern Cancer Cooperation Group (ECOG) score status 0-2
- Agree to sign the consent form
Exclusion
- Congenital AA
- Cytogenetic evidence of clonal hematologic bone marrow disease
- PNH clone ≥50%
- Allergic to ATG, cyclosporine and hexapopal in the past
- Uncontrolled infection or bleeding at enrollment
- Received hematopoietic stem cell transplantation (HSCT) before enrollment
- Any concomitant malignancy within 5 years, except for local skin basal cell carcinoma
- A history of thromboembolic events, myocardial infarction, or stroke (including antiphospholipid antibody syndrome); Currently using anticoagulants
- Pregnant or lactating women
- Situations considered unsuitable for clinical research by other researchers
Key Trial Info
Start Date :
January 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2025
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT06009965
Start Date
January 20 2023
End Date
January 31 2025
Last Update
August 24 2023
Active Locations (1)
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1
Peking union medical college hospital
Beijing, China