The purpose of this study was to compare the responses of 2 different doses of plerixafor in patients with Non-Hodgkin's Lymphoma (NHL) who received an autologous stem cell transplant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
City of Hope National Medical Center
Duarte, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Princess Margaret Hospital
Toronto, Ontario, Canada
Samsung Medical Center
Seoul, South Korea
Proportion of Patients Who Achieved at Least 5*10^6 Cluster of Differentiation 34+ (CD34+) Cells Per Kilogram (Cells/kg)
The cumulative number of CD34+ cells/kg (body weight) collected over all apheresis sessions (up to a maximum of 4 sessions) was used to determine if a patient has achieved the target of \>=5\*10\^6 CD34+ cells/kg (optimum number of CD34+ cells required for transplantation) within 4 days of apheresis. The proportion of patients who achieved the target was reported as percentages for each treatment arm.
Time frame: Day 5 up to Day 8
Area Under the Concentration-time Curve From Time 0 to 10 Hours (AUC [0-10])
Time frame: 0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5
Proportion of Patients Who Achieved at Least 2*10^6 CD34+ Cells/kg in Less Than or Equal to 4 Days of Apheresis
The cumulative number of CD34+ cells/kg (body weight) collected over all apheresis sessions (up to a maximum of 4 sessions) was used to determine if a patient has achieved the target of \>= 2\*10\^6 CD34+ cells/kg (minimum number of CD34+ cells required for transplantation) within 4 days of apheresis. The proportion of patients who achieved the target was reported as percentages for each treatment arm.
Time frame: Day 5 up to Day 8
Median Number of Days of Apheresis to Collect at Least 2*10^6 CD34+ Cells/kg
Time frame: Day 5 up to Day 8
Median Number of Days of Apheresis to Collect at Least 5*10^6 CD34+ Cells/kg
Time frame: Day 5 up to Day 8
Total Number of CD34+ Cells/kg Collected Over up to 4 Aphereses
The cumulative number of CD34+ cells/kg (body weight) collected over all apheresis sessions (up to a maximum of 4 sessions) was reported.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
St. Mary's Hospital
Seoul, South Korea
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Time frame: Day 5 up to Day 8
Mean Fold Increase in Peripheral Blood CD34+ Cell Count Following Plerixafor
Fold increase was calculated as CD34+ cell count on Day 5 divided by CD34+ cell count on Day 4.
Time frame: Baseline (pre G-CSF dose on Day 4) to Day 5 (prior to first apheresis)
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5
Time to Reach Maximum Plasma Concentration (Tmax)
Time frame: 0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5
Terminal Elimination Half-life (T1/2)
T1/2 is the time required for the plasma concentration to decrease to one half.
Time frame: 0 (pre-plerixafor dose), 0.5, 1, 4 hours post-plerixafor dose on Day 4; 9-10 hours post-plerixafor dose (pre G-CSF dose) on Day 5, 10-11 hours post-plerixafor dose (prior to first apheresis) on Day 5