The study is to determine if NHL patients mobilized with G-CSF (10 µg/kg/day \[GRAN® only\]) plus 0.24 mg/kg/day of plerixafor are more likely to achieve a target number of ≥5 × 10\^6 CD34+ cells/kg in 4 or fewer days of apheresis than NHL patients mobilized with G-CSF plus placebo.
Eligible patients who are unable to achieve adequate apheresis cell counts may enter an Open-Label Rescue Period where they will receive plerixafor, following the same study schedule as during the Double-Blind Treatment Period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
10 µg/kg/day G-CSF, administered by subcutaneous (SC) injection
0.24 mg/kg/day subcutaneous injection
0.24mg/kg/day placebo (0.9% Sodium Chloride) administered by subcutaneous injection
Investigational Site Number 156017
Beijing, China
Investigational Site Number 156001
Beijing, China
Investigational Site Number 156005
Number of patients who meet the target of ≥5 × 10^6 CD34+ cells/kg in 4 or fewer days of apheresis
Time frame: Days 5- Day8
Number of patients who achieve ≥2 × 10^6 CD34+ cells/kg within 4 or fewer days of apheresis
Time frame: Day 5 - Day 8
Number of days of apheresis to collect ≥2 × 10^6 CD34+ cells/kg
Time frame: Up to achieve the target of collecting ≥2 × 10^6 CD34+ cells/kg
Number of days of apheresis to collect ≥5 × 10^6 CD34+ cells/kg
Time frame: Up to achieve the target of collecting ≥5 × 10^6 CD34+ cells/kg
Total number of CD34+ cells collected
Time frame: Day 5 - Day 8
Time from transplantation to neutrophil and platelet (PLT) engraftment
Time frame: up to 30 days post-transplantation
Number of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: from signed Informed Consent Form (ICF) to 30 days post-transplant and then ongoing as needed
Maximum plasma concentration (Cmax)
Time frame: Day 4 - Day 5
Time to reach Cmax (Tmax)
Time frame: Day 4 - Day 5
Area Under the Curve 0 to 10 hours post-dose (AUC0-10)
Time frame: Day 4 - Day 5
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Beijing, China
Investigational Site Number 156002
Beijing, China
Investigational Site Number 156003
Beijing, China
Investigational Site Number 156020
Chongqing, China
Investigational Site Number 156016
Fuzhou, China
Investigational Site Number 156021
Guangzhou, China
Investigational Site Number 156011
Hangzhou, China
Investigational Site Number 156018
Nanjing, China
...and 6 more locations
Area Under the Curve 0 to last observed concentration (AUClast)
Time frame: Day 4 - Day 5
Area Under the Curve (AUC)
Time frame: Day 4 - Day 5
Percentage of extrapolation of AUC (AUCext)
Time frame: Day 4 - Day 5
Half life (T1/2)
Time frame: Day 4 - Day 5
Volume of distribution (Vz/F)
Time frame: Day 4 - Day 5
Total body clearance (CL/F)
Time frame: Day 4 - Day 5
Peripheral blood CD34+ cell counts (Pharmacodynamic analysis)
Time frame: Day 4 - Day 5
The fold-increase in the number of circulating CD34+ following the first dose of plerixafor or placebo, with the first apheresis day (Day 5) value serving as the primary estimate
Time frame: Day 5 - Day 8