Phase II study of intrabone single unit cord blood transplantation for hematological malignancies

Makoto Murata, Yoshinobu Maeda, Masayoshi Masuko, Yasushi Onishi, Tomoyuki Endo, Seitaro Terakura, Yuichi Ishikawa, Chisako Iriyama, Yoko Ushijima, Tatsunori Goto, Nobuharu Fujii, Mitsune Tanimoto, Hironori Kobayashi, Yasuhiko Shibasaki, Noriko Fukuhara, Yoshihiro Inamoto, Ritsuro Suzuki, Yoshihisa Kodera, Tadashi Matsushita, Hitoshi Kiyoi & 2 others Tomoki Naoe, Tetsuya Nishida

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

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 × 107/kg (range, 2.0-4.9 × 107/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 × 109/L, reticulocytes ≥1%, and platelets ≥20 × 109/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.

Original languageEnglish
JournalCancer Science
DOIs
Publication statusAccepted/In press - 2017

Fingerprint

Hematologic Neoplasms
Fetal Blood
Transplantation
Graft vs Host Disease
Neutrophils
HLA-A Antigens
HLA-B Antigens
Survival
Reticulocytes
Incidence
Tacrolimus
HLA-DR Antigens
Granulocyte Colony-Stimulating Factor
Methotrexate
Blood Cells
Blood Platelets
Transplants
Safety
Injections

Keywords

  • Cord blood transplantation
  • Engraftment
  • Hematological malignancy
  • Intrabone
  • Non-myeloablative conditioning

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

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.

In: Cancer Science, 2017.

Research output: Contribution to journalArticle

Murata, M, Maeda, Y, Masuko, M, Onishi, Y, Endo, T, Terakura, S, Ishikawa, Y, Iriyama, C, Ushijima, Y, Goto, T, Fujii, N, Tanimoto, M, Kobayashi, H, Shibasaki, Y, Fukuhara, N, Inamoto, Y, Suzuki, R, Kodera, Y, Matsushita, T, Kiyoi, H, Naoe, T & Nishida, T 2017, 'Phase II study of intrabone single unit cord blood transplantation for hematological malignancies', Cancer Science. https://doi.org/10.1111/cas.13291
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. In: Cancer Science. 2017.
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abstract = "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 × 107/kg (range, 2.0-4.9 × 107/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 × 109/L, reticulocytes ≥1{\%}, and platelets ≥20 × 109/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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AU - Murata, Makoto

AU - Maeda, Yoshinobu

AU - Masuko, Masayoshi

AU - Onishi, Yasushi

AU - Endo, Tomoyuki

AU - Terakura, Seitaro

AU - Ishikawa, Yuichi

AU - Iriyama, Chisako

AU - Ushijima, Yoko

AU - Goto, Tatsunori

AU - Fujii, Nobuharu

AU - Tanimoto, Mitsune

AU - Kobayashi, Hironori

AU - Shibasaki, Yasuhiko

AU - Fukuhara, Noriko

AU - Inamoto, Yoshihiro

AU - Suzuki, Ritsuro

AU - Kodera, Yoshihisa

AU - Matsushita, Tadashi

AU - Kiyoi, Hitoshi

AU - Naoe, Tomoki

AU - Nishida, Tetsuya

PY - 2017

Y1 - 2017

N2 - 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 × 107/kg (range, 2.0-4.9 × 107/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 × 109/L, reticulocytes ≥1%, and platelets ≥20 × 109/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.

AB - 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 × 107/kg (range, 2.0-4.9 × 107/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 × 109/L, reticulocytes ≥1%, and platelets ≥20 × 109/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.

KW - Cord blood transplantation

KW - Engraftment

KW - Hematological malignancy

KW - Intrabone

KW - Non-myeloablative conditioning

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