Phase I study of graft-versus-host disease prophylaxis including bortezomib for allogeneic hematopoietic cell transplantation from unrelated donors with one or ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2019-09-27

AUTHORS

Takahiko Nakane, Hiroshi Okamura, Yumi Tagaito, Shiro Koh, Takuro Yoshimura, Yosuke Makuuchi, Satoru Nanno, Mika Nakamae, Asao Hirose, Yasuhiro Nakashima, Hideo Koh, Masayuki Hino, Hirohisa Nakamae

ABSTRACT

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/m2). A dose of 1.3 mg/m2 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/m2. Prophylaxis against GVHD using a regimen including bortezomib thus seems feasible for HLA-mismatched unrelated allo-HCT. More... »

PAGES

736-742

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s12185-019-02743-6

DOI

http://dx.doi.org/10.1007/s12185-019-02743-6

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1121307601

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/31560116


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28 schema:description 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/m2). A dose of 1.3 mg/m2 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/m2. Prophylaxis against GVHD using a regimen including bortezomib thus seems feasible for HLA-mismatched unrelated allo-HCT.
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35 GVH direction
36 GVHD
37 HLA
38 HLA loci mismatches
39 Japanese patients
40 acute GVHD
41 administration
42 allo-HCT
43 allogeneic hematopoietic cell transplantation
44 antigen
45 bone marrow donors
46 bortezomib
47 cases
48 cell transplantation
49 chimerism
50 chronic GVHD
51 complete donor chimerism
52 day 1
53 day 100
54 developed chronic GVHD
55 direction
56 disease prophylaxis
57 donor chimerism
58 donors
59 dose
60 dose levels
61 dose-limiting toxicity
62 engraftment
63 follow
64 grade II acute GVHD
65 grade III
66 graft
67 hematopoietic cell transplantation
68 host disease (GVHD) prophylaxis
69 human leukocyte antigen
70 initial dose
71 late-onset acute GvHD
72 leukocyte antigen
73 levels
74 loci
75 locus mismatch
76 m2
77 marrow donors
78 median follow
79 methotrexate
80 mismatch
81 months
82 neutrophil engraftment
83 optimal dose
84 patients
85 period
86 phase I
87 prophylaxis
88 regimen
89 relapse
90 short-term methotrexate
91 single-antigen mismatch
92 toxicity
93 transplantation
94 unrelated donors
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