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Human Leukocyte Antigen (HLA)-Haploidentical Hematopoietic Stem Cell Transplantation for Patients With Aplastic Anemia

NCT01105273 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2013-01-03

No results posted yet for this study

Summary

Rationale: Chemotherapy with fludarabine, cyclophosphamide and anti-thymocyte globulin may induce the engraftment cross the immunologic barrier in the setting of HLA-haploidentical allogeneic hematopoietic cell transplantation. In addition, depletion CD3±CD19 cells may contribute to prevent developing severe acute graft versus host disease (GVHD) in haploidentical transplantation.

Purpose: This phase I/II trial is to evaluate the safety and efficacy of fludarabine, cyclophosphamide and antithymocyte globulin with CD3±CD19 depleted graft from haploidentical donors in treating patients with aplastic anemia.

Conditions

  • Aplastic Anemia

Interventions

BIOLOGICAL

anti-thymocyte globulin

On days -3 to -1

BIOLOGICAL

filgrastim

Beginning on day 4 and continuing until blood counts recover

DRUG

Fludarabine

30mg/M2 once daily IV on days -6 to -2

DRUG

Cyclophosphamide

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

PROCEDURE

CD3±CD19 depleted hematopoietic stem 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
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2012-07-31
Completion
2012-07-31

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 NCT01105273 on ClinicalTrials.gov