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Haploidentical Stem Cell Transplantation for Children With Acquired Severe Aplastic Anemia

NCT01759732 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2013-01-03

No results posted yet for this study

Summary

Rationale: Fludarabine, cyclophosphamide, anti-thymocyte globulin and low-dose total body irradiation (LD-TBI) may induce the engraftment cross the immunologic barrier in the setting of HLA-haploidentical allogeneic hematopoietic cell transplantation. In addition, depletion of CD3 cells may contribute to prevent developing severe acute graft versus host disease (GVHD) in haploidentical transplantation.

Purpose: Phase II trials to evaluate the efficacy of haploidentical stem cell transplantation with fixed dose of T cells after in vitro T cell depletion using CD3 monoclonal antibody for children with acquired severe aplastic anemia

Conditions

  • Acquired Aplastic Anemia

Interventions

DRUG

Fludarabine

40mg/M2 once daily IV on days -7 to -4

DRUG

Cyclophosphamide

60 mg/kg IV on day-3 and -2

BIOLOGICAL

anti-thymocyte globulin

BIOLOGICAL

filgrastim

RADIATION

Total body irradiation

200 cGy per day on D-5 \& -4

PROCEDURE

CD3-depleted hematopoietic cell transplantation

Immunogenetic depletion on CliniMACS

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Ho Joon Im, MD, PhD · Asan Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-12-31
Completion
2015-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

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 NCT01759732 on ClinicalTrials.gov