drugset / Trial / NCT01572181

Study of a Reduced-toxicity Myeloablative Conditioning Regimen Using Fludarabine and Full Doses of Intravenous Busulfan in Pediatric Patients Not Eligible for Standard Myeloablative Conditioning Regimens

NCT01572181

Phase 2 Completed 50 enrolled Nantes University Hospital
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to assess transplant-related mortality (TRM) at one year after allogeneic hematopoietic stem cell transplantation (allo-HSCT) prepared by a "reduced toxicity myeloablative" conditioning regimen in young patients (children and adolescents) with hematologic malignancies.

Timeline

Start
2012-04
Primary completion
2017-10-24
Completion
2017-10-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Busulfan Small molecule 3.2 mg/kg Intravenous
Subject Fludarabine Small molecule 30 mg/m2 Intravenous
Subject Thymoglobulin Protein / enzyme biologic 2.5 mg/kg