Efficacy of IST Combined With TPO-RA in the Treatment of AA and Establishment of a Recurrence Pre… (NCT06009965) | Clinical Trial Compass
UnknownPhase 4
Efficacy of IST Combined With TPO-RA in the Treatment of AA and Establishment of a Recurrence Prediction System
China210 participantsStarted 2023-01-20
Plain-language 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+Herombopag, and patients with NSAA receive CsA+ Herombopag. Investigators explored possible indicators of participants' predictive efficacy and built predictive models. After the participants achieved response, they used a tapering regimen, observed relapse and clonal evolution, and developed a predictive model of relapse.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. Congenital AA
✕. Cytogenetic evidence of clonal hematologic bone marrow disease
✕. 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