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

NCT00881933 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2012-03-26

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • The Korean Society of Pediatric Hematology Oncology

    lead NETWORK

Principal Investigators

  • Hyo Seop Ahn, M.D, Ph.D · The Korean Society of Pediatric Hematology Oncology

Study Design

Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00881933 on ClinicalTrials.gov