Phase II study of tacrolimus and methotrexate for prophylaxis of acute graft-versus-host disease after HLA-A, B, and DRB1 genotypically mismatched unrelated bone marrow transplantation among Japanese patients

Int J Hematol. 2009 Jan;89(1):98-105. doi: 10.1007/s12185-008-0219-8. Epub 2008 Dec 4.

Abstract

Bone marrow transplantation from unrelated donors (UR-BMT) has been considered to be effective for patients with hematological malignancies who have no suitable related donor. However, disparities of HLA between a recipient and a donor increase the risk of severe acute graft-versus-host disease (GVHD). We evaluated GVHD prophylaxis using tacrolimus and methotrexate for HLA-A, B, or DRB1 genotypically mismatched UR-BMT. Fifty-five patients were enrolled in this study. The incidence of grade III to IV acute GVHD was 23.6% for all patients. No significant difference in the incidence of grade III to IV acute GVHD was observed between HLA-A or B 1 locus mismatch transplantation (18.8%) and HLA-DRB1 1 locus mismatch transplantation (16.7%) (P = 0.96). The incidence of chronic GVHD was 71.7%. Disease-free survival at 5 years was 53.2% for patients with standard risk disease and 24.5% for patients with high-risk disease. Patients with chronic GVHD exhibited better disease-free survival than those without chronic GVHD (53.2 vs. 30.9%, P = 0.011). Twenty patients (36.4%) had a relapse of leukemia and 14 of them died of recurrent leukemia. This study indicates tacrolimus and methotrexate can lower the risk of severe acute GVHD after HLA-A, B, or DRB1 genotypically 1 locus mismatched UR-BMT.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Disease
  • Adolescent
  • Adult
  • Asian People
  • Bone Marrow Transplantation / immunology
  • Bone Marrow Transplantation / methods*
  • Bone Marrow Transplantation / mortality
  • Cause of Death
  • Female
  • Graft vs Host Disease / prevention & control*
  • HLA Antigens / genetics*
  • HLA-A Antigens
  • HLA-B Antigens
  • HLA-DR Antigens
  • HLA-DRB1 Chains
  • Histocompatibility Testing
  • Humans
  • Male
  • Methotrexate / administration & dosage*
  • Middle Aged
  • Tacrolimus / administration & dosage*
  • Treatment Outcome
  • Young Adult

Substances

  • HLA Antigens
  • HLA-A Antigens
  • HLA-B Antigens
  • HLA-DR Antigens
  • HLA-DRB1 Chains
  • Tacrolimus
  • Methotrexate