Plerixafor for mobilization and collection of haematopoietic stem cells for autologous transplantation in Japanese patients with non-Hodgkin lymphoma: a randomized phase 2 study
- 191 Downloads
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.
KeywordsPlerixafor 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.
- 8.Genzyme L. Summary of product characteristics for Mozobil. 2017. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001030/WC500030686.pdf. Accessed August 2017.
- 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
- 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.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.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
- 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