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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
Sponsor: Nantes University Hospital
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.
Official title: Phase 2 Study of a Reduced-toxicity Myeloablative Conditionning Regimen Using Fludarabine and Full Doses of iv Busulfan in Pediatric Patients Not Eligible for Standard Myeloablative Conditioning Regimens
Key Details
Gender
All
Age Range
12 Months - 25 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2012-04
Completion Date
2017-10-24
Last Updated
2026-09-14
Healthy Volunteers
No
Conditions
Interventions
Fludarabine IV- Busulfan IV (Busilvex®) - Anti-thymocyte globulines (Thymoglobuline®)
* IV fludarabine (30 mg/m²/day for 5 days) * IV Busulfan (Busilvex 3.2 mg/kg/day for 4 days) (the Busulfan dose is to be adapted to the weight of the child according to the drug label) * Anti-thymocyte globulines (Thymogolubuline, 2.5 mg/kg/day for 2 days).
Locations (15)
University Hospital
Besançon, France
University Hospital
Bordeaux, France
University Hospital
Clermont-Ferrand, France
University Hospital
Grenoble, France
University Hospital
Lille, France
University Hospital
Lyon, France
University Hospital
Marseille, France
University Hospital
Montpellier, France
University Hospital
Nancy, France
University Hospital
Nantes, France
University Hopsital
Paris, France
University Hospital
Paris, France
University Hospital
Rennes, France
University Hopsital
Rouen, France
University Hospital
Strasbourg, France