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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,...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
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.
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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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