PMID- 31560116
OWN - NLM
STAT- MEDLINE
DCOM- 20200415
LR  - 20220801
IS  - 1865-3774 (Electronic)
IS  - 0925-5710 (Linking)
VI  - 110
IP  - 6
DP  - 2019 Dec
TI  - Phase I study of graft-versus-host disease prophylaxis including bortezomib for 
      allogeneic hematopoietic cell transplantation from unrelated donors with one or 
      two HLA loci mismatches in Japanese patients.
PG  - 736-742
LID - 10.1007/s12185-019-02743-6 [doi]
AB  - This phase I study was designed for graft-versus-host disease (GVHD) prophylaxis 
      including bortezomib in allogeneic hematopoietic cell transplantation (allo-HCT) 
      from human leukocyte antigen (HLA)-mismatched unrelated donors in Japanese 
      patients. Patients were administered bortezomib on days 1, 4, and 7, with 
      short-term methotrexate and tacrolimus. Three bortezomib dose levels were 
      prepared (1.0, 1.3, and 1.5 mg/m(2)). A dose of 1.3 mg/m(2) was planned for 
      administration to the initial six patients, and was adjusted if dose-limiting 
      toxicity developed. Five of six patients enrolled for the initial dose had bone 
      marrow donors. Two cases had single-antigen and single-allele mismatches; four 
      had single-antigen mismatch at the A, B, C, and/or DRB1 loci in the GVH 
      direction. All patients achieved neutrophil engraftment and complete donor 
      chimerism. Three patients developed grade II acute GVHD, and none developed grade 
      III-IV GVHD or any dose-limiting toxicity attributable to bortezomib by day 100. 
      Two patients developed late-onset acute GVHD, and two developed chronic GVHD, but 
      all cases were manageable. All patients were alive without relapse after a median 
      follow-up period of 52 months. The optimal dose of bortezomib was determined to 
      be 1.3 mg/m(2). Prophylaxis against GVHD using a regimen including bortezomib 
      thus seems feasible for HLA-mismatched unrelated allo-HCT.
FAU - Nakane, Takahiko
AU  - Nakane T
AUID- ORCID: 0000-0002-5521-4247
AD  - Hematology, Graduate School of Medicine, Osaka City University, 1-4-3 
      Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan. nakane@med.osaka-cu.ac.jp.
FAU - Okamura, Hiroshi
AU  - Okamura H
AD  - Hematology, Graduate School of Medicine, Osaka City University, 1-4-3 
      Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan.
FAU - Tagaito, Yumi
AU  - Tagaito Y
AD  - Hematology, Graduate School of Medicine, Osaka City University, 1-4-3 
      Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan.
FAU - Koh, Shiro
AU  - Koh S
AD  - Hematology, Graduate School of Medicine, Osaka City University, 1-4-3 
      Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan.
FAU - Yoshimura, Takuro
AU  - Yoshimura T
AD  - Hematology, Graduate School of Medicine, Osaka City University, 1-4-3 
      Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan.
FAU - Makuuchi, Yosuke
AU  - Makuuchi Y
AD  - Hematology, Graduate School of Medicine, Osaka City University, 1-4-3 
      Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan.
FAU - Nanno, Satoru
AU  - Nanno S
AD  - Hematology, Graduate School of Medicine, Osaka City University, 1-4-3 
      Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan.
FAU - Nakamae, Mika
AU  - Nakamae M
AD  - Hematology, Graduate School of Medicine, Osaka City University, 1-4-3 
      Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan.
FAU - Hirose, Asao
AU  - Hirose A
AD  - Hematology, Graduate School of Medicine, Osaka City University, 1-4-3 
      Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan.
FAU - Nakashima, Yasuhiro
AU  - Nakashima Y
AD  - Hematology, Graduate School of Medicine, Osaka City University, 1-4-3 
      Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan.
FAU - Koh, Hideo
AU  - Koh H
AD  - Hematology, Graduate School of Medicine, Osaka City University, 1-4-3 
      Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan.
FAU - Hino, Masayuki
AU  - Hino M
AD  - Hematology, Graduate School of Medicine, Osaka City University, 1-4-3 
      Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan.
FAU - Nakamae, Hirohisa
AU  - Nakamae H
AD  - Hematology, Graduate School of Medicine, Osaka City University, 1-4-3 
      Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
DEP - 20190927
PL  - Japan
TA  - Int J Hematol
JT  - International journal of hematology
JID - 9111627
RN  - 0 (HLA Antigens)
RN  - 69G8BD63PP (Bortezomib)
RN  - WM0HAQ4WNM (Tacrolimus)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Bortezomib/*therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Graft vs Host Disease/etiology/*prevention & control
MH  - HLA Antigens
MH  - Hematopoietic Stem Cell Transplantation/*methods
MH  - *Histocompatibility
MH  - Humans
MH  - Japan
MH  - Male
MH  - Methotrexate/therapeutic use
MH  - Middle Aged
MH  - Premedication/methods
MH  - Tacrolimus/therapeutic use
MH  - Transplantation, Homologous
MH  - *Unrelated Donors
OTO - NOTNLM
OT  - Allogeneic hematopoietic cell transplantation
OT  - Bortezomib
OT  - Graft-versus-host disease prophylaxis
OT  - HLA-mismatched unrelated donor
EDAT- 2019/09/29 06:00
MHDA- 2020/04/16 06:00
CRDT- 2019/09/28 06:00
PHST- 2019/07/12 00:00 [received]
PHST- 2019/09/19 00:00 [accepted]
PHST- 2019/09/19 00:00 [revised]
PHST- 2019/09/29 06:00 [pubmed]
PHST- 2020/04/16 06:00 [medline]
PHST- 2019/09/28 06:00 [entrez]
AID - 10.1007/s12185-019-02743-6 [pii]
AID - 10.1007/s12185-019-02743-6 [doi]
PST - ppublish
SO  - Int J Hematol. 2019 Dec;110(6):736-742. doi: 10.1007/s12185-019-02743-6. Epub 
      2019 Sep 27.