NCT01572181View on ClinicalTrials.gov

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

PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

October 24, 2017

Study Completion Date

October 24, 2017

Conditions
Hematologic Malignancy
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)."

Trial Locations (15)

Unknown

University Hospital, Besançon

University Hospital, Bordeaux

University Hospital, Clermont-Ferrand

University Hospital, Grenoble

University Hospital, Lille

University Hospital, Lyon

University Hospital, Marseille

University Hospital, Montpellier

University Hospital, Nancy

University Hospital, Nantes

University Hopsital, Paris

University Hospital, Paris

University Hospital, Rennes

University Hopsital, Rouen

University Hospital, Strasbourg

All Listed Sponsors
lead

Nantes University Hospital

OTHER

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 | Biotech Hunter | Biotech Hunter