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

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.

journal_name

Int J Hematol

authors

Matsue K,Kumagai K,Sugiura I,Ishikawa T,Igarashi T,Sato T,Uchiyama M,Miyamoto T,Ono T,Ueda Y,Kiguchi T,Sunaga Y,Sasaki T,Suzuki K

doi

10.1007/s12185-018-2505-4

subject

Has Abstract

pub_date

2018-11-01 00:00:00

pages

524-534

issue

5

eissn

0925-5710

issn

1865-3774

pii

10.1007/s12185-018-2505-4

journal_volume

108

pub_type

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