Overview

Eltrombopag+hATG+CsA vs. hATG+CsA in Children With Severe AA

Status:
Recruiting

Trial end date:
2022-10-20

Target enrollment:
0

Participant gender:
All

Summary

The analysis of our own clinical data suggests that majority of the hematologic responses observed after the course of h-ATG/CsA is partial, and about 10% tend to have cyclosporine dependence. The aim of the current study is to improve the rate and the quality of hematologic response as well as to prevent delayed complications such as relapse and clonal progression by means of adding eltrombopag to standard immunosuppressive therapy

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Criteria

Inclusion Criteria:

1. Clinical diagnosis of severe and very severe Aplastic anemia

2. 2 - 18 years old

3. Written informed consent signed by a parent or legal guardian prior to initiation of
any study specific procedure.

4. Absence of HLA-identical family member

Exclusion Criteria:

1. myelodysplastic syndrome 4. Prior immunosuppressive therapy 5. Patients with hepatic,
renal or cardiac failure, or any other life- threatening concurrent disease 6.
hypersensitivity to any of the component medications 7. Creatinine >2.5 mg/dL× the upper
limit of normal, 8. Total bilirubin >1.5 × the upper limit of normal mg/dL , 9. Aspartate
aminotransferase (AST) or alanine aminotransferase (ALT) >3-5 × the upper limit of normal