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

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: The Korean Society of Pediatric Hematology Oncology

Current Primary Outcome: To evaluate the engraftment potential of fludarabine, busulfan plus thymoglobulin conditioning regimen for cord blood transplantation (CBT) in severe aplastic anemia. [ Time Frame: From Oct 2008. to Sep 2011 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • To evaluate the incidence and severity of toxicity and treatment related mortality [ Time Frame: From Oct 2008. to Sep 2011 ]
  • To evaluate overall and event free survival rate [ Time Frame: From Oct 2008. to Sep 2011 ]
  • To evaluate acute and chronic GVHD [ Time Frame: From Oct 2008. to Sep 2011 ]
  • To evaluate immunologic recovery after CBT [ Time Frame: From Oct 2008. to Sep 2011 ]


Original Secondary Outcome: Same as current

Information By: The Korean Society of Pediatric Hematology Oncology

Dates:
Date Received: April 14, 2009
Date Started: November 2008
Date Completion: September 2012
Last Updated: March 23, 2012
Last Verified: March 2012