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 MatsueEmail author
  • 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


The present study ( 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.


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



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.


  1. 1.
    Salvinoa MA, Ruiz J. Hematopoietic progenitor cell mobilization for autologous transplantation—a literature review. Rev Bras Hematol Hemoter. 2016;38:28–36.CrossRefGoogle Scholar
  2. 2.
    Sung AD, Grima DT, Bernard LM, Brown S, Carrum G, Holmberg L, et al. Outcomes and costs of autologous stem cell mobilization with chemotherapy plus G-CSF vs G-CSF alone. Bone Marrow Transplant. 2013;48:1444–9.CrossRefPubMedPubMedCentralGoogle Scholar
  3. 3.
    Morgan SJ, Seymour JF, Grigg A, Matthews JP, Prince HM, Wolf MM, et al. Predictive factors for successful stem cell mobilization in patients with indolent lymphoproliferative disorders previously treated with fludarabine. Leukemia. 2004;18:1034–8.CrossRefPubMedGoogle Scholar
  4. 4.
    Demirer T, Buckner CD, Gooley T, Appelbaum FR, Rowley S, Chauncey T, et al. Factors influencing collection of peripheral blood stem cells in patients with multiple myeloma. Bone Marrow Transplant. 1996;17:937–41.PubMedGoogle Scholar
  5. 5.
    Gertz MA. Current status of stem cell mobilization. Br J Haematol. 2010;150:647–62.CrossRefPubMedGoogle Scholar
  6. 6.
    Kessans MR, Gatesman ML, Kockler DR. Plerixafor: a peripheral blood stem cell mobilizer. Pharmacotherapy. 2010;30:485–92.CrossRefPubMedGoogle Scholar
  7. 7.
    Hübel K, Liles WC, Broxmeyer HE, Rodger E, Wood B, Cooper S, et al. Leukocytosis and mobilization of CD34+ Hematopoietic progenitor cells by AMD3100, a CXCR4 antagonist. Support Cancer Ther. 2004;1:165–72.CrossRefPubMedGoogle Scholar
  8. 8.
    Genzyme L. Summary of product characteristics for Mozobil. 2017. Accessed August 2017.
  9. 9.
    DiPersio JF, Stadtmauer EA, Nademanee A, Micallef IN, Stiff PJ, Kaufman JL, et al. Plerixafor and G-CSF versus placebo and G-CSF to mobilize hematopoietic stem cells for autologous stem cell transplantation in patients with multiple myeloma. Blood. 2009;113:5720–6.PubMedGoogle Scholar
  10. 10.
    Stiff P, Micallef I, McCarthy P, Magalhaes-Silverman M, Weisdorf D, Territo M, et al. Treatment with plerixafor in non-Hodgkin’s lymphoma and multiple myeloma patients to increase the number of peripheral blood stem cells when given a mobilizing regimen of G-CSF: implications for the heavily pretreated patient. Biol Blood Marrow Transplant. 2009;15:249–56.CrossRefPubMedGoogle Scholar
  11. 11.
    Cashen A, Lopez S, Gao F, Calandra G, MacFarland R, Badel K, et al. A phase II study of plerixafor (AMD3100) plus G-CSF for autologous hematopoietic progenitor cell mobilization in patients with Hodgkin lymphoma. Biol Blood Marrow Transplant. 2008;14:1253–61.CrossRefPubMedGoogle Scholar
  12. 12.
    Ri M, Matsue K, Sunami K, Shimazaki C, Hayashi A, Sunaga Y, et al. Efficacy and safety of plerixafor for the mobilization/collection of peripheral hematopoietic stem cells for autologous transplantation in Japanese patients with multiple myeloma. Int J Hematol. 2017;106:562–72.CrossRefPubMedGoogle Scholar
  13. 13.
    DiPersio JF, Micallef IN, Stiff PJ, Bolwell BJ, Maziarz RT, Jacobsen E, et al. Phase III prospective randomized double-blind placebo-controlled trial of plerixafor plus granulocyte colony-stimulating factor compared with placebo plus granulocyte colony-stimulating factor for autologous stem-cell mobilization and transplantation for patients with non-Hodgkin’s lymphoma. J Clin Oncol. 2009;27:4767–73.CrossRefPubMedGoogle Scholar
  14. 14.
    Mohty M, Hübel K, Kröger N, Aljurf M, Apperley J, Basak GW, et al. Autologous haematopoietic stem cell mobilisation in multiple myeloma and lymphoma patients: a position statement from the European Group for Blood and Marrow Transplantation. Bone Marrow Transplant. 2014;49:865–72.CrossRefPubMedGoogle Scholar
  15. 15.
    Lemoli RM. New strategies for stem cell mobilization. Mediterr J Hematol Infect Dis. 2012;4:e2012066.CrossRefPubMedPubMedCentralGoogle Scholar
  16. 16.
    Shpall EJ, Champlin R, Glaspy JA. Effect of CD34+ peripheral blood progenitor cell dose on hematopoietic recovery. Biol Blood Marrow Transplant. 1998;4:84–92.CrossRefPubMedGoogle Scholar
  17. 17.
    Blystad AK, Delabie J, Kvaløy S, Holte H, Vålerhaugen H, Ikonomou I, et al. Infused CD34 cell dose, but not tumour cell content of peripheral blood progenitor cell grafts, predicts clinical outcome in patients with diffuse large B-cell lymphoma and follicular lymphoma grade 3 treated with high-dose therapy. Br J Haematol. 2004;125:605–12.CrossRefPubMedGoogle Scholar
  18. 18.
    Toor AA, Ayers J, Strupeck J, Parthasarathy M, Creech S, Rodriguez T, et al. Favourable results with a single autologous stem cell transplant following conditioning with busulphan and cyclophosphamide in patients with multiple myeloma. Br J Haematol. 2004;124:769–76.CrossRefPubMedGoogle Scholar
  19. 19.
    Giralt S, Costa L, Schriber J, Dipersio J, Maziarz R, McCarty J, et al. Optimizing autologous stem cell mobilization strategies to improve patient outcomes: consensus guidelines and recommendations. Biol Blood Marrow Transplant. 2014;20:295–308.CrossRefPubMedGoogle Scholar
  20. 20.
    Mohty M, Azar N, Chabannon C, Le Gouill S, Karlin L, Farina L, et al. Plerixafor in poor mobilizers with non-Hodgkin’s lymphoma: a multi-center time-motion analysis. Bone Marrow Transplant. 2018;53:246–54.CrossRefPubMedGoogle Scholar

Copyright information

© The Japanese Society of Hematology 2018

Authors and Affiliations

  • Kosei Matsue
    • 1
    Email author
  • 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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