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COMPLETED
NCT01572181
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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