Combining IST and TPO-RA for treating Aplastic Anemia
Establishment of an Efficacy and Relapse Prediction System for Immunosuppressants Combined With Thrombopoietin Receptor Agonists in the Treatment of Aplastic Anemia
This study is testing a new combination treatment for patients with Aplastic Anemia who can’t have a transplant to see if it helps them feel better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06009965 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of a combination treatment involving anti-thymocyte globulin (ATG), cyclosporine A (CsA), and Herombopag for treatment-naive patients with Aplastic Anemia (AA) who are not candidates for transplantation. Patients with severe AA (SAA) will receive ATG+CsA+Herombopag, while those with non-severe AA (NSAA) will receive CsA+Herombopag. The study aims to monitor treatment responses, taper medications, and develop a predictive model for relapse based on patient indicators. The trial is conducted at Peking Union Medical College Hospital in Beijing, China.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with a confirmed diagnosis of Aplastic Anemia who are not eligible for hematopoietic stem cell transplantation.
Not a fit: Patients with congenital Aplastic Anemia or those who have received prior hematopoietic stem cell transplantation will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with Aplastic Anemia by providing an effective non-transplant therapy.
How similar studies have performed: Previous studies have shown promising results with similar treatment combinations in Aplastic Anemia, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age: 18-75 years old, gender is not limited 2. Definite diagnosis of AA 3. No HSCT indication or unconditional HSCT 4. 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 5. Baseline serum transaminase, total bilirubin and serum creatinine were less than 1.5 times the normal value 6. Baseline liver and kidney function was less than 1.5 times the normal value 7. Eastern Cancer Cooperation Group (ECOG) score status 0-2 8. Agree to sign the consent form Exclusion Criteria: 1. Congenital AA 2. Cytogenetic evidence of clonal hematologic bone marrow disease 3. PNH clone ≥50% 4. Allergic to ATG, cyclosporine and hexapopal in the past 5. Uncontrolled infection or bleeding at enrollment 6. Received hematopoietic stem cell transplantation (HSCT) before enrollment 7. Any concomitant malignancy within 5 years, except for local skin basal cell carcinoma 8. A history of thromboembolic events, myocardial infarction, or stroke (including antiphospholipid antibody syndrome); Currently using anticoagulants 9. Pregnant or lactating women 10. Situations considered unsuitable for clinical research by other researchers
Where this trial is running
Beijing
- Peking union medical college hospital — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Bing Bing, PhD — Peking Union Medical College Hospital
- Study coordinator: Yali Du, Master
- Email: yali_crazy@126.com
- Phone: +8615845992396
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.