NCT00881933

Study of Fludarabine + Cyclophosphamide + TBI Conditioning Regimen for Double Units Cord Blood Transplantation(CBT)in Severe Aplastic Anemia(SAA)

Phase I/II Study of Fludarabine, Cyclophosphamide Plus TBI Conditioning Regimen for Double Units Cord Blood Transplantation in Severe Aplastic Anemia

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: The Korean Society of Pediatric Hematology Oncology · Network
• Sex: All
• Age: 1 Year – 21 Years
• Healthy volunteers: Not accepted

Summary

Severe aplastic anemia is a fatal disease and patients without HLA matched siblings need alternative treatment option. Cord blood transplantation (CBT) has become an alternative treatment means in various diseases, but it has not been proved to be good for severe aplastic anemia. Double units CBT is proposed to have better engraftment potential and and we reported successful double units UCBT after engraftment failure with single unit with promising result. To increase the engraftment potential, fludarabine, cyclophosphamide plus TBI conditioning regimen for double units cord blood transplantation was proposed for the patient with severe aplastic anemia without HLA-matched donor.

Conditions

• Aplastic Anemia

Interventions

Type	Name	Description
OTHER	Cyclophosphosphamide, TBI	fludarabine (30 mg/m2 once daily i.v. on days -7, -6, -5, -4, -3, \& -2) (if body weight \< 10 kg or if age \< 1 year: 1.33 mg/kg) cyclophosphamide (60 mg/kg once daily i.v. on days -9, \& -8) total body irradiation (3G on days -1)

Timeline

• Start date: 2008-11-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2009-04-15
• Last updated: 2012-03-26

Locations

1 site across 1 country: South Korea