A phase II study of post-transplant cyclophosphamide combined with tacrolimus for GVHD prophylaxis after HLA-matched related/unrelated allogeneic hematopoietic stem cell ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2021-09-29

AUTHORS

Hirohisa Nakamae, Takahiko Nakane, Hiroshi Okamura, Hideo Koh, Yasuhiro Nakashima, Asao Hirose, Mika Nakamae, Mitsutaka Nishimoto, Masatomo Kuno, Yosuke Makuuchi, Naonori Harada, Teruhito Takakuwa, Masayuki Hino

ABSTRACT

A combination of three post-transplant drugs, cyclophosphamide (PTCy), a calcineurin inhibitor, and mycophenolate mofetil, has long been used for prophylaxis of graft-versus-host-disease (GVHD) after HLA-haploidentical allogeneic hematopoietic cell transplantation (allo-HCT). Recently, this combination has been used following HLA-matched allo-HCT as well, but the optimal combination of drugs for GVHD prophylaxis in an HLA-matched setting remains unclear. This prospective phase II study evaluated the safety and efficacy of PTCy plus tacrolimus (TAC) for GVHD prophylaxis after allo-HCT from HLA-matched related donors (MRD) or HLA-matched unrelated donors (MUD). The cumulative incidences of grades II–IV and III–IV acute GVHD at 100 days post-transplantation were 18% and 5.9%, respectively, in the MRD group, and 18% and 9.1%, respectively, in the MUD group. The cumulative incidences of moderate to severe chronic GVHD at 1 year were 12% and 9.1% in the MRD and MUD groups, respectively. The 1-year overall survival rates in the MRD and MUD groups were 88% and 64%, respectively, and the 1-year GVHD-free, relapse free survival rates were 59% and 50%, respectively. These results suggest that GVHD prophylaxis with a less intensive double drug combination (PT/Cy and TAC) might be feasible after HLA-matched allo-HCT.Clinical Trial Notation This trial was a prospective single-center trial registered at the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR; identification number: UMIN000023890) and the Japan Registry of Clinical Trials (jRCTs051180143). More... »

PAGES

77-86

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s12185-021-03228-1

DOI

http://dx.doi.org/10.1007/s12185-021-03228-1

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1141488876

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/34586587


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30 schema:description A combination of three post-transplant drugs, cyclophosphamide (PTCy), a calcineurin inhibitor, and mycophenolate mofetil, has long been used for prophylaxis of graft-versus-host-disease (GVHD) after HLA-haploidentical allogeneic hematopoietic cell transplantation (allo-HCT). Recently, this combination has been used following HLA-matched allo-HCT as well, but the optimal combination of drugs for GVHD prophylaxis in an HLA-matched setting remains unclear. This prospective phase II study evaluated the safety and efficacy of PTCy plus tacrolimus (TAC) for GVHD prophylaxis after allo-HCT from HLA-matched related donors (MRD) or HLA-matched unrelated donors (MUD). The cumulative incidences of grades II–IV and III–IV acute GVHD at 100 days post-transplantation were 18% and 5.9%, respectively, in the MRD group, and 18% and 9.1%, respectively, in the MUD group. The cumulative incidences of moderate to severe chronic GVHD at 1 year were 12% and 9.1% in the MRD and MUD groups, respectively. The 1-year overall survival rates in the MRD and MUD groups were 88% and 64%, respectively, and the 1-year GVHD-free, relapse free survival rates were 59% and 50%, respectively. These results suggest that GVHD prophylaxis with a less intensive double drug combination (PT/Cy and TAC) might be feasible after HLA-matched allo-HCT.Clinical Trial Notation This trial was a prospective single-center trial registered at the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR; identification number: UMIN000023890) and the Japan Registry of Clinical Trials (jRCTs051180143).
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37 GVHD
38 GVHD prophylaxis
39 HLA
40 II study
41 Japan Registry
42 MRD
43 MRD group
44 MUD group
45 PTCy
46 Trials Registry
47 University Hospital Medical Information Network Clinical Trials Registry
48 acute GVHD
49 allo-HCT
50 allogeneic hematopoietic cell transplantation
51 allogeneic hematopoietic stem cell transplantation
52 calcineurin inhibitors
53 cell transplantation
54 chronic GVHD
55 clinical trials
56 combination
57 cumulative incidence
58 cyclophosphamide
59 days
60 donors
61 double drug combinations
62 drug combinations
63 drugs
64 efficacy
65 free survival rate
66 grade II
67 graft
68 group
69 hematopoietic cell transplantation
70 hematopoietic stem cell transplantation
71 incidence
72 inhibitors
73 mofetil
74 mycophenolate mofetil
75 notation
76 optimal combination
77 overall survival rate
78 phase II study
79 post-transplant cyclophosphamide
80 prophylaxis
81 prophylaxis of graft
82 prospective phase II study
83 prospective single-center trial
84 rate
85 registry
86 related donors
87 results
88 safety
89 setting
90 severe chronic GVHD
91 single-center trial
92 stem cell transplantation
93 study
94 survival rate
95 tacrolimus
96 transplantation
97 trials
98 unrelated allogeneic hematopoietic stem cell transplantation
99 unrelated donors
100 years
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