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

Tetsuya Nishida, Tohru Murayama, Hisamaru Hirai, Shinichiro Okamoto, Hiroshi Sao, Masamichi Hara, Heiwa Kanamori, Yoshiko Atsuta, Keitaro Matsuo, Yasuo Morishima, Yoshihisa Kodera

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5 Citations (Scopus)


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.

Original languageEnglish
Pages (from-to)98-105
Number of pages8
JournalInternational Journal of Hematology
Issue number1
Publication statusPublished - 2009 Jan



  • GVHD prophylaxis
  • HLA mismatched UR-BMT
  • Tacrolimus

ASJC Scopus subject areas

  • Hematology

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