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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: HLA-haploidentical Allogeneic Hematopoietic Cell Transplantation Using CD3±CD19 Depletion for Patients With Aplastic Anemia After Conditioning of Fludarabine, Cycloph

Brief 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.


Detailed Summary:
Sponsor: Asan Medical Center

Current Primary Outcome: To assess the engraftment rate and survival of CD3±CD19 depleted haploidentical peripheral blood stem cell transplantation after conditioning with fludarabine, cyclophosphamide and anti-thymocyte globulin. [ Time Frame: 2 years post-transplant ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • To assess engraftment and graft failure [ Time Frame: 28 days post-transplant ]
    Number of patients who failed to engraft by 28 days.
  • To estimate the risk of acute GVHD [ Time Frame: 100 days post-transplant ]
    Number of patients with acute GVHD.
  • To assess treatment related mortality [ Time Frame: 100 days post-transplant ]
    Number of death after transplantation
  • To estimate overall survival [ Time Frame: 1 year after transplantation ]


Original Secondary Outcome: Same as current

Information By: Asan Medical Center

Dates:
Date Received: April 8, 2010
Date Started: July 2009
Date Completion:
Last Updated: December 30, 2012
Last Verified: December 2012