drugset / Trial / NCT01238328

Hematopoietic Stem Cell Transplantation for Mucopolysaccharidosis

NCT01238328

Phase 2/3 Unknown 10 enrolled Tehran University of Medical Sciences
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy and side effects of donor hematopoietic cells using chemotherapy regimen without total-body irradiation in children undergoing a hematopoietic stem cell transplant for Mucopolysaccharidosis. The blood stem cells will be derived from either related donor or unrelated umbilical cord blood or haploidentical donor.

Timeline

Start
2009-09
Primary completion
2012-09
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Background Antithymocyte globulin (ATG) rabbit Unknown 10 mg/kg
Background Busulfan Small molecule 16 mg/kg Oral
Background Busulfan Small molecule 20 mg/kg Oral
Background Cyclophosphamide Other / unclassified 40 mg/kg
Background Cyclophosphamide Other / unclassified 200 mg/kg Intravenous
Background Cyclosporine Peptide 9 mg/kg Intravenous
Background Fludarabine Small molecule 160 mg/m2
Background MTX Unknown 6 mg/m2 Intravenous

Indications