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Phase II study of intrabone single unit cord blood transplantation for hematological malignancies
The outcomes of cord blood transplantation with non‐irradiated reduced‐intensity conditioning for hematological malignancies need to be improved because of graft failure and delayed engraftment. Intrabone infusion of cord blood cells has the potential to resolve the problems. In this phase II study,...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5543458/ https://www.ncbi.nlm.nih.gov/pubmed/28582607 http://dx.doi.org/10.1111/cas.13291 |
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author | Murata, Makoto Maeda, Yoshinobu Masuko, Masayoshi Onishi, Yasushi Endo, Tomoyuki Terakura, Seitaro Ishikawa, Yuichi Iriyama, Chisako Ushijima, Yoko Goto, Tatsunori Fujii, Nobuharu Tanimoto, Mitsune Kobayashi, Hironori Shibasaki, Yasuhiko Fukuhara, Noriko Inamoto, Yoshihiro Suzuki, Ritsuro Kodera, Yoshihisa Matsushita, Tadashi Kiyoi, Hitoshi Naoe, Tomoki Nishida, Tetsuya |
author_facet | Murata, Makoto Maeda, Yoshinobu Masuko, Masayoshi Onishi, Yasushi Endo, Tomoyuki Terakura, Seitaro Ishikawa, Yuichi Iriyama, Chisako Ushijima, Yoko Goto, Tatsunori Fujii, Nobuharu Tanimoto, Mitsune Kobayashi, Hironori Shibasaki, Yasuhiko Fukuhara, Noriko Inamoto, Yoshihiro Suzuki, Ritsuro Kodera, Yoshihisa Matsushita, Tadashi Kiyoi, Hitoshi Naoe, Tomoki Nishida, Tetsuya |
author_sort | Murata, Makoto |
collection | PubMed |
description | The outcomes of cord blood transplantation with non‐irradiated reduced‐intensity conditioning for hematological malignancies need to be improved because of graft failure and delayed engraftment. Intrabone infusion of cord blood cells has the potential to resolve the problems. In this phase II study, 21 adult patients with hematological malignancy received intrabone transplantation of serological HLA‐A, B, and DR ≥4/6 matched single cord blood with a median number of cryopreserved total nucleated cells of 2.7 × 10(7)/kg (range, 2.0–4.9 × 10(7)/kg) following non‐irradiated fludarabine‐based reduced‐intensity conditioning. Short‐term methotrexate and tacrolimus were given as graft‐versus‐host disease prophylaxis, and granulocyte colony‐stimulating factor was given after transplantation. No severe adverse events related to intrabone injection were observed. The cumulative incidences of neutrophils ≥0.5 × 10(9)/L, reticulocytes ≥1%, and platelets ≥20 × 10(9)/L recoveries were 76.2%, 71.4%, and 76.2%, respectively, with median time to recoveries of 17, 28, and 32 days after transplantation, respectively. The probability of survival with neutrophil engraftment on day 60 was 71.4%, and overall survival at 1 year after transplantation was 52.4%. The incidences of grade II–IV and III–IV acute graft‐versus‐host disease were 44% and 19%, respectively, with no cases of chronic graft‐versus‐host disease. The present study showed the safety of direct intrabone infusion of cord blood. Further analysis is required to confirm the efficacy of intrabone single cord blood transplantation with non‐irradiated reduced‐intensity conditioning for adult patients with hematological malignancy. This study was registered with UMIN‐CTR, number 000000865. |
format | Online Article Text |
id | pubmed-5543458 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-55434582017-08-09 Phase II study of intrabone single unit cord blood transplantation for hematological malignancies Murata, Makoto Maeda, Yoshinobu Masuko, Masayoshi Onishi, Yasushi Endo, Tomoyuki Terakura, Seitaro Ishikawa, Yuichi Iriyama, Chisako Ushijima, Yoko Goto, Tatsunori Fujii, Nobuharu Tanimoto, Mitsune Kobayashi, Hironori Shibasaki, Yasuhiko Fukuhara, Noriko Inamoto, Yoshihiro Suzuki, Ritsuro Kodera, Yoshihisa Matsushita, Tadashi Kiyoi, Hitoshi Naoe, Tomoki Nishida, Tetsuya Cancer Sci Original Articles The outcomes of cord blood transplantation with non‐irradiated reduced‐intensity conditioning for hematological malignancies need to be improved because of graft failure and delayed engraftment. Intrabone infusion of cord blood cells has the potential to resolve the problems. In this phase II study, 21 adult patients with hematological malignancy received intrabone transplantation of serological HLA‐A, B, and DR ≥4/6 matched single cord blood with a median number of cryopreserved total nucleated cells of 2.7 × 10(7)/kg (range, 2.0–4.9 × 10(7)/kg) following non‐irradiated fludarabine‐based reduced‐intensity conditioning. Short‐term methotrexate and tacrolimus were given as graft‐versus‐host disease prophylaxis, and granulocyte colony‐stimulating factor was given after transplantation. No severe adverse events related to intrabone injection were observed. The cumulative incidences of neutrophils ≥0.5 × 10(9)/L, reticulocytes ≥1%, and platelets ≥20 × 10(9)/L recoveries were 76.2%, 71.4%, and 76.2%, respectively, with median time to recoveries of 17, 28, and 32 days after transplantation, respectively. The probability of survival with neutrophil engraftment on day 60 was 71.4%, and overall survival at 1 year after transplantation was 52.4%. The incidences of grade II–IV and III–IV acute graft‐versus‐host disease were 44% and 19%, respectively, with no cases of chronic graft‐versus‐host disease. The present study showed the safety of direct intrabone infusion of cord blood. Further analysis is required to confirm the efficacy of intrabone single cord blood transplantation with non‐irradiated reduced‐intensity conditioning for adult patients with hematological malignancy. This study was registered with UMIN‐CTR, number 000000865. John Wiley and Sons Inc. 2017-06-29 2017-08 /pmc/articles/PMC5543458/ /pubmed/28582607 http://dx.doi.org/10.1111/cas.13291 Text en © 2017 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs (http://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Original Articles Murata, Makoto Maeda, Yoshinobu Masuko, Masayoshi Onishi, Yasushi Endo, Tomoyuki Terakura, Seitaro Ishikawa, Yuichi Iriyama, Chisako Ushijima, Yoko Goto, Tatsunori Fujii, Nobuharu Tanimoto, Mitsune Kobayashi, Hironori Shibasaki, Yasuhiko Fukuhara, Noriko Inamoto, Yoshihiro Suzuki, Ritsuro Kodera, Yoshihisa Matsushita, Tadashi Kiyoi, Hitoshi Naoe, Tomoki Nishida, Tetsuya Phase II study of intrabone single unit cord blood transplantation for hematological malignancies |
title | Phase II study of intrabone single unit cord blood transplantation for hematological malignancies |
title_full | Phase II study of intrabone single unit cord blood transplantation for hematological malignancies |
title_fullStr | Phase II study of intrabone single unit cord blood transplantation for hematological malignancies |
title_full_unstemmed | Phase II study of intrabone single unit cord blood transplantation for hematological malignancies |
title_short | Phase II study of intrabone single unit cord blood transplantation for hematological malignancies |
title_sort | phase ii study of intrabone single unit cord blood transplantation for hematological malignancies |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5543458/ https://www.ncbi.nlm.nih.gov/pubmed/28582607 http://dx.doi.org/10.1111/cas.13291 |
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