International Journal of Hematology

DOI: 10.1007/s12185-018-2505-4 Pages: 524-534

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

1. Kameda Medical Center, Department of Hematology and Oncology

2. Chiba Cancer Center, Division of Hematology and Oncology

3. Toyohashi Municipal Hospital, Department of Hematology & Oncology

4. Kobe City Medical Center General Hospital, Department of Hematology

5. Gunma Cancer Center, Hematology/Oncology

6. Sapporo Medical University Hospital, Department of Medical Oncology and Hematology

7. Mitsui Memorial Hospital, Department of Hematology

8. Japanese Red Cross Society Suwa Hospital, Hematology and Oncology

9. Kyushu University, Medicine and Biosystemic Science, Graduate School of Medical Sciences

10. Hamamatsu University School of Medicine, Department of Internal Medicine III

11. Kurashiki Central Hospital, Department of Haematology/Oncology

12. Chugoku Central Hospital, Department of Hematology

13. Sanofi K.K.

14. Japanese Red Cross Medical Center, Department of Hematology

Correspondence to:
Kosei Matsue
Tel: 81 4 7092 2211
Email: koseimatsue@gmail.com

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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.

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