Reduced Toxicity Fludarabine (Flu) + Cyclophosphamide (CPM) + Rabbit Antithymocyte Globulin (rATG) Conditioning Regimen for Unrelated Donor Transplantation in Severe Aplastic Anemia (SAA)

  • STATUS
    Recruiting
  • participants needed
    33
  • sponsor
    The Korean Society of Pediatric Hematology Oncology
Updated on 7 November 2020
graft versus host disease
total body irradiation
fludarabine
cyclophosphamide
cell transplantation
antithymocyte globulin
thymoglobulin
neutrophil count
conditioning regimen
aplastic anemia
severe aplastic anemia

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 graft versus host disease (GVHD) and rejection of organ transplants. As the fludarabine based conditioning regimens without total body irradiation have been reported to be promising for transplantation from alternative donors in SAA, thymoglobulin was added to fludarabine and cyclophosphamide conditioning to reduce GVHD and to allow good engraftment in unrelated donor transplantation. Our previous phase II study of fludarabine, cyclophosphamide plus thymoglobulin conditioning resulted in good engraftment (100%) and survival rate (74%). But grade III/IV toxicities occurred in 25% of patients and all events were treatment related mortalities. As cyclophosphamide is more toxic agent than fludarabine, we plan a new phase II study re; 'reduced toxicity fludarabine, cyclophosphamide plus thymoglobulin conditioning regimen for unrelated donor transplantation in severe aplastic anemia' by reducing dosage of cyclophosphamide and increasing dosage of fludarabine.

Details
Condition Aplastic Anemia
Treatment Cyclophosphamide, Fludarabine, Thymoglobulin
Clinical Study IdentifierNCT00882323
SponsorThe Korean Society of Pediatric Hematology Oncology
Last Modified on7 November 2020

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