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Plerixafor for mobilization and collection of haematopoietic stem cells for autologous transplantation in Japanese patients with non-Hodgkin lymphoma: a randomized phase 2 study

International Journal of Hematology volume 108, pages 524–534 (2018)Cite this article

A Correction to this article was published on 30 August 2018

This article has been updated

Abstract

The present study (ClinicalTrials.gov Identifier: NCT02221492) was conducted to assess the efficacy and safety of plerixafor for the mobilization and collection of haematopoietic stem cells (HSCs) for autologous transplantation in Japanese non-Hodgkin lymphoma (NHL) patients. In this randomized phase 2 study, patients received granulocyte-colony stimulating factor (G-CSF, filgrastim) 400 µg/m²/day for up to 8 days. Starting on the evening of day 4, patients received, for up to 4 days, either plerixafor (240 µg/kg/day) in the G-CSF+ plerixafor arm (GP arm) or G-CSF alone arm (G arm). On day 5, daily apheresis started and was continued for up to 4 days, or until ≥ 5 × 106 CD34+ cells/kg was collected. A total of 32 patients were randomized to either the GP or G arm. In the GP arm, 9/16 patients (56.3%) achieved collection of ≥ 5 × 106 CD34+ cells/kg in ≤ 4 days of apheresis, while 1/16 patient (6.3%) achieved this target in the G arm. The most common treatment-emergent adverse events in the GP arm were back pain (56.3%), platelet count decreased (25.0%), headache, diarrhoea, and nausea (18.8% each). We found that plerixafor was well tolerated and effective for the mobilization and collection of peripheral HSCs for autologous transplantation in Japanese NHL patients.

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Change history

  • 30 August 2018

    The affiliation of the last author, Kenshi Suzuki has been incorrectly published in the original publication of the article. The correct affiliation is provided in this correction.

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Acknowledgements

The study was funded by Sanofi K.K., Tokyo, Japan. Medical writing assistance, supported financially by Sanofi K.K. was provided by Honyaku Center Inc. All authors have reviewed and provided feedback on all drafts, and approved the final version of the manuscript.

Author information

Author notes

  1. Tsutomu Sato & Kenshi Suzuki

    Present address: Department of Hematology, Mitsui Memorial Hospital, Tokyo, Japan

Affiliations

  1. Department of Hematology and Oncology, Kameda Medical Center, 929 Higashi-cho, Kamogawa, Chiba, 296-8602, Japan

    Kosei Matsue

  2. Division of Hematology and Oncology, Chiba Cancer Center, Chiba, Japan

    Kyoya Kumagai

  3. Department of Hematology & Oncology, Toyohashi Municipal Hospital, Toyohashi, Japan

    Isamu Sugiura

  4. Department of Hematology, Kobe City Medical Center General Hospital, Kobe, Japan

    Takayuki Ishikawa

  5. Hematology/Oncology, Gunma Cancer Center, Ota, Japan

    Tadahiko Igarashi

  6. Department of Medical Oncology and Hematology, Sapporo Medical University Hospital, Sapporo, Japan

    Tsutomu Sato

  7. Hematology and Oncology, Japanese Red Cross Society Suwa Hospital, Suwa, Japan

    Michihiro Uchiyama

  8. Medicine and Biosystemic Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan

    Toshihiro Miyamoto

  9. Department of Internal Medicine III, Hamamatsu University School of Medicine, Hamamatsu, Japan

    Takaaki Ono

  10. Department of Haematology/Oncology, Kurashiki Central Hospital, Kurashiki, Japan

    Yasunori Ueda

  11. Department of Hematology, Chugoku Central Hospital, Fukuyama, Japan

    Toru Kiguchi

  12. Sanofi K.K., Tokyo, Japan

    Yoshinori Sunaga & Toru Sasaki

  13. Department of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan

    Kenshi Suzuki

Authors
  1. Kosei Matsue
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  2. Kyoya Kumagai
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  3. Isamu Sugiura
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  4. Takayuki Ishikawa
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  5. Tadahiko Igarashi
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  6. Tsutomu Sato
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  7. Michihiro Uchiyama
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  8. Toshihiro Miyamoto
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  9. Takaaki Ono
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  10. Yasunori Ueda
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  11. Toru Kiguchi
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  12. Yoshinori Sunaga
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  13. Toru Sasaki
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  14. Kenshi Suzuki
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Corresponding author

Correspondence to Kosei Matsue.

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Conflict of interest

T. Ono has received research funding from Celgene K.K., Kyowa Hakko Kirin Co., Ltd., Chugai Pharmaceutical Co., Ltd., Toyama Chemical Co., Ltd. and MSD K.K. Y. Ueda has consulting fees from Kainos Laboratories, Inc. and Ablynx NV, and has received research funding from Eli Lilly Japan K.K., Sumitomo Dainippon Pharma Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Celgene K.K., Symbio Pharmaceuticals Limited, Astellas Pharma Inc. and Eisai Co., Ltd. Y. Sunaga and T. Sasaki are employees of Sanofi K.K. The other authors have no conflicts of interest to declare.

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Matsue, K., Kumagai, K., Sugiura, I. et al. Plerixafor for mobilization and collection of haematopoietic stem cells for autologous transplantation in Japanese patients with non-Hodgkin lymphoma: a randomized phase 2 study. Int J Hematol 108, 524–534 (2018). https://doi.org/10.1007/s12185-018-2505-4

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  • DOI: https://doi.org/10.1007/s12185-018-2505-4

Keywords

  • Plerixafor
  • G-CSF
  • Non-Hodgkin’s lymphoma (NHL)
  • Stem cell
  • Apheresis