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Plerixafor for mobilization and collection of haematopoietic stem cells for autologous transplantation in Japanese patients with non-Hodgkin lymphoma: a randomized phase 2 study
- Source :
- International journal of hematology. 108(5)
- Publication Year :
- 2017
-
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.
- Subjects :
- Adult
Male
medicine.medical_specialty
Benzylamines
Nausea
Phases of clinical research
Filgrastim
Cyclams
Gastroenterology
03 medical and health sciences
0302 clinical medicine
Heterocyclic Compounds
Internal medicine
medicine
Autologous transplantation
Humans
Autografts
Aged
Peripheral Blood Stem Cell Transplantation
Hematology
business.industry
Plerixafor
Lymphoma, Non-Hodgkin
Middle Aged
Hematopoietic Stem Cells
Hematopoietic Stem Cell Mobilization
Haematopoiesis
Apheresis
030220 oncology & carcinogenesis
Female
medicine.symptom
business
030215 immunology
medicine.drug
Subjects
Details
- ISSN :
- 18653774
- Volume :
- 108
- Issue :
- 5
- Database :
- OpenAIRE
- Journal :
- International journal of hematology
- Accession number :
- edsair.doi.dedup.....145a8577ec19971de3a922f0e1810004