A phase IV, randomized, multicenter, open-label trial comparing efficacy and systemic exposure for a standard weight-based dose versus a fixed dose of plerixafor in combination with G-CSF in patients with Non-Hodgkin’s lymphoma weighing ≤70 kg
Journal
Bone Marrow Transplantation
Journal Volume
54
Journal Issue
2
Pages
258-264
Date Issued
2019
Author(s)
Abstract
A randomized, multicenter, open-label study explored the effect of a fixed-dose (FD) of plerixafor versus the approved weight-based (WB) dose for the mobilization of hematopoietic stem cells (HSCs) in patients with non-Hodgkin’s lymphoma and a body weight of ?70 kg. After mobilization with granulocyte colony-stimulating factor (G-CSF) 10 μg/kg/day for 4 days, patients were randomized 1:1 to either plerixafor FD 20 mg (n = 30) or WB 0.24 mg/kg (n = 31) on the evening of Day 4. Co-primary endpoints were the proportion of patients achieving ?5 × 10 6 CD34 + cells/kg in ?4 days of apheresis, and total systemic exposure to plerixafor (area under the concentration–time curve from 0 to 10 h [AUC 0–10 ]). There was no statistically significant difference between the proportion of patients attaining the primary efficacy endpoint (60% FD arm, 55% WB arm; P = 0.395). Exposure to plerixafor was greater in the FD arm relative to the WB arm; however, there was no appreciable difference regarding fold increases of peripheral blood CD34 + cells. The safety profile was similar between treatment groups. These results suggest there is no statistically significant difference in HSC mobilization with a standard WB dosing regimen of plerixafor plus G-CSF in patients with low body weight compared with an FD regimen. ? 2018, The Author(s).
SDGs
Other Subjects
filgrastim; plerixafor; antineoplastic agent; CD34 antigen; granulocyte colony stimulating factor; heterocyclic compound; plerixafor octahydrochloride; adult; aged; anemia; apheresis; area under the curve; Article; autologous hematopoietic stem cell transplantation; body weight; CD34 selection; controlled study; diarrhea; dose response; drug efficacy; drug half life; drug safety; evening dosage; female; hematopoietic stem cell; human; hypocalcemia; hypokalemia; major clinical study; male; maximum concentration; morning dosage; multicenter study; nausea; nonhodgkin lymphoma; phase 4 clinical trial; plasma concentration-time curve; priority journal; randomized controlled trial; stem cell mobilization; thrombocytopenia; time to maximum plasma concentration; clinical trial; dose calculation; hematopoietic stem cell transplantation; middle aged; nonhodgkin lymphoma; procedures; underweight; Adult; Antigens, CD34; Antineoplastic Combined Chemotherapy Protocols; Body Weight; Drug Dosage Calculations; Female; Granulocyte Colony-Stimulating Factor; Hematopoietic Stem Cell Mobilization; Hematopoietic Stem Cell Transplantation; Heterocyclic Compounds; Humans; Lymphoma, Non-Hodgkin; Male; Middle Aged; Thinness
Publisher
Nature Publishing Group
Type
journal article