Adverse effects of ATG/ALG treatment in aplastic anemia
A Study on the Dynamics and Grading Criteria Construction of Adverse Reactions to ATG/ALG Therapy in Aplastic Anemia
This project will see what side effects people with aplastic anemia experience when they receive ATG or ALG therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT07461116 on ClinicalTrials.gov |
What this trial studies
This prospective, single-center cohort will enroll 200 patients with aplastic anemia who are receiving ATG or ALG as their first immunosuppressive therapy. Investigators will systematically record and describe clinical adverse reactions during and after treatment, including timing, severity, and management. Patients who have had a prior hematopoietic stem cell transplant or who receive ATG/ALG only as transplant conditioning are excluded. The collected data are intended to provide a foundation for developing targeted strategies to prevent and treat treatment-related complications.
Who should consider this trial
Good fit: Patients with aplastic anemia who meet the Camitta diagnostic criteria and are receiving ATG or ALG for the first time are ideal candidates.
Not a fit: Patients who have previously undergone hematopoietic stem cell transplantation, who receive ATG/ALG only as part of transplant conditioning, or who are not receiving ATG/ALG will not be included and are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the findings could help clinicians recognize and manage ATG/ALG side effects more effectively, improving patient safety and outcomes.
How similar studies have performed: Adverse reactions to ATG and ALG have been described in prior reports, so this study builds on existing knowledge by collecting prospective, systematic data at a single center.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Meet the diagnostic criteria for aplastic anemia (Camitta criteria); * Receiving ATG/ALG immunosuppressive therapy for the first time; Exclusion Criteria: * Previously received hematopoietic stem cell transplantation; * Aplastic anemia patients receiving ATG/ALG as part of transplant conditioning regimen;
Where this trial is running
Tianjin
- Regenerative Medicine Center and Red Blood Cell Disorders Center — Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Weiwang Li, PhD
- Email: liweiwang@ihcams.ac.cn
- Phone: 15332132036
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.