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

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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.

Original languageEnglish
Pages (from-to)524-534
Number of pages11
JournalInternational journal of hematology
Volume108
Issue number5
DOIs
Publication statusPublished - Nov 1 2018

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All Science Journal Classification (ASJC) codes

  • Hematology

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