Clinical Trial: Flu+CPM+rATG Conditioning Regimes for Unrelated Bone Marrow Transplantation (UBMT)(or Mobilized Peripheral Blood)in Severe Aplastic Anemia (SAA)

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

Official Title: Fludarabine, Cyclophosphamide Plus Thymoglobulin Conditioning Regimen for Unrelated Bone Marrow (or Mobilized Peripheral Blood) Transplantation in Severe Aplastic Anemia

Brief Summary: Anti-thymocyte globulin (ATG) has been used in severe aplastic anemia as a part of the conditioning regimen. Among the many kinds of ATG preparations, thymoglobulin had been found to be more effective in preventing GVHD and rejection of organ transplants. As the fludarabine based conditioning regimens without total body irradiation have been reported to be promising for BMT/PBSCT from alternative donors in SAA, thymoglobulin was added to fludarabine and cyclophosphamide conditioning to reduce GVHD and to allow good engraftment in UBMT/UPBSCT.

Detailed Summary: GVHD prophylaxis recommendation tacrolimus (0.03 mg/kg/day i.v. by continuous infusion from day -2 and taper with an oral form until 1 year after BMT/PBSCT) methotrexate (15 mg/m2 i.v. on days 1 and 10 mg/m2 i.v. on days 3, 6, 11)
Sponsor: The Korean Society of Pediatric Hematology Oncology

Current Primary Outcome:

  • To evaluate the engraftment potential, incidence and severity of acute graft versus host disease,toxicity of conditioning regimen for UBMT in SAA. [ Time Frame: From Jan. 1. 2006 to Dec. 31. 2008. For 3 years. ]
  • To evaluate overall and EFS follow-up of 1 year after UBMT/PBSCT. [ Time Frame: From Jan. 1. 2006 to Dec. 31. 2008. For 3 years ]


Original Primary Outcome: Same as current

Current Secondary Outcome: To evaluate chronic GVHD and immunologic recovery after UBMT/PBSCT. and the efficacy of UBMT/PBSCT before immuno-suppressive therapy with anti-thymocyte globulin in severe aplastic anemia and long term toxicity of non-TBI based conditioning [ Time Frame: From Jan. 1. 2006 to Dec. 31. 2008. For 3 years. ]

Original Secondary Outcome: Same as current

Information By: The Korean Society of Pediatric Hematology Oncology

Dates:
Date Received: August 18, 2008
Date Started: January 2006
Date Completion: December 2012
Last Updated: March 23, 2012
Last Verified: March 2012