Tacrolimus as prophylaxis for acute graft-versus-host disease in reduced intensity cord blood transplantation for adult patients with advanced hematologic diseases

Transplantation. 2007 Aug 15;84(3):316-22. doi: 10.1097/01.tp.0000269796.23593.16.


Background: Myeloablative cord blood transplantation (CBT) for adult patients offers a 90% chance of engraftment with a 50% rate of transplant-related mortality, mostly attributable to infection. We have demonstrated the feasibility of reduced-intensity CBT (RI-CBT) for adult patients, in which cyclosporine was used for acute graft-versus-host disease (GVHD) prophylaxis. Transplantation-related mortality (TRM) was 27% within 100 days. Therefore our objective was to evaluate the feasibility of RI-CBT with tacrolimus as GVHD prophylaxis for adult patients with hematologic malignancies.

Methods: Thirty-four patients with a median age of 56.5 years (range; 22-68) with hematologic diseases underwent RI-CBT at Toranomon Hospital between November 2003 and September 2004. Preparative regimen comprised fludarabine 25 mg/m2 on days -7 to -3, melphalan 80 mg/m2 on day -2, and 4 Gy total body irradiation on day -1. GVHD prophylaxis was continuous intravenous infusion of tacrolimus 0.03 mg/kg, starting on day -1.

Results: Thirty-one patients achieved neutrophil engraftment at a median of day 20. Median infused total cell dose was 2.4 x 10E7/kg (range; 1.6-4.8). Thirty-two patients achieved complete donor chimerism at day 60. Grade II-IV acute GVHD occurred in 45% of patients, with a median onset of day 26. Primary disease recurred in five patients, and TRM within 100 days was 12%. Estimated 1-year overall survival was 70%.

Conclusion: This study demonstrated the possible improvement in transplant-related mortality by tacrolimus as GVHD prophylaxis in adult RI-CBT recipients.

Publication types

  • Clinical Trial

MeSH terms

  • Acute Disease
  • Adult
  • Aged
  • Cord Blood Stem Cell Transplantation / adverse effects*
  • Cord Blood Stem Cell Transplantation / methods
  • Cyclosporine / therapeutic use
  • Female
  • Graft Survival / drug effects
  • Graft vs Host Disease / etiology
  • Graft vs Host Disease / prevention & control*
  • Hematologic Diseases / therapy*
  • Humans
  • Immunosuppressive Agents / adverse effects
  • Immunosuppressive Agents / therapeutic use*
  • Male
  • Middle Aged
  • Prognosis
  • Tacrolimus / adverse effects
  • Tacrolimus / therapeutic use*


  • Immunosuppressive Agents
  • Cyclosporine
  • Tacrolimus