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International Journal of Hematology

, Volume 108, Issue 5, pp 524–534 | Cite as

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

  • Kosei Matsue
  • Kyoya Kumagai
  • Isamu Sugiura
  • Takayuki Ishikawa
  • Tadahiko Igarashi
  • Tsutomu Sato
  • Michihiro Uchiyama
  • Toshihiro Miyamoto
  • Takaaki Ono
  • Yasunori Ueda
  • Toru Kiguchi
  • Yoshinori Sunaga
  • Toru Sasaki
  • Kenshi Suzuki
Original Article
  • 286 Downloads

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.

Keywords

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

Notes

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.

Compliance with ethical standards

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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Copyright information

© The Japanese Society of Hematology 2018

Authors and Affiliations

  • Kosei Matsue
    • 1
  • Kyoya Kumagai
    • 2
  • Isamu Sugiura
    • 3
  • Takayuki Ishikawa
    • 4
  • Tadahiko Igarashi
    • 5
  • Tsutomu Sato
    • 6
    • 7
  • Michihiro Uchiyama
    • 8
  • Toshihiro Miyamoto
    • 9
  • Takaaki Ono
    • 10
  • Yasunori Ueda
    • 11
  • Toru Kiguchi
    • 12
  • Yoshinori Sunaga
    • 13
  • Toru Sasaki
    • 13
  • Kenshi Suzuki
    • 7
    • 14
  1. 1.Department of Hematology and OncologyKameda Medical CenterKamogawaJapan
  2. 2.Division of Hematology and OncologyChiba Cancer CenterChibaJapan
  3. 3.Department of Hematology & OncologyToyohashi Municipal HospitalToyohashiJapan
  4. 4.Department of HematologyKobe City Medical Center General HospitalKobeJapan
  5. 5.Hematology/OncologyGunma Cancer CenterOtaJapan
  6. 6.Department of Medical Oncology and HematologySapporo Medical University HospitalSapporoJapan
  7. 7.Department of HematologyMitsui Memorial HospitalTokyoJapan
  8. 8.Hematology and OncologyJapanese Red Cross Society Suwa HospitalSuwaJapan
  9. 9.Medicine and Biosystemic Science, Graduate School of Medical SciencesKyushu UniversityFukuokaJapan
  10. 10.Department of Internal Medicine IIIHamamatsu University School of MedicineHamamatsuJapan
  11. 11.Department of Haematology/OncologyKurashiki Central HospitalKurashikiJapan
  12. 12.Department of HematologyChugoku Central HospitalFukuyamaJapan
  13. 13.Sanofi K.K.TokyoJapan
  14. 14.Department of HematologyJapanese Red Cross Medical CenterTokyoJapan

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