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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 12 Months – 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hematologic Malignancy

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2012-04-01
• Primary completion: 2017-10-24
• Completion: 2017-10-24
• First posted: 2012-04-06
• Last updated: 2018-04-05

Locations

15 sites across 1 country: France