A Phase 3 interventional study of Granulocyte-colony stimulating factor (G-CSF) and Plerixafor in Non-Hodgkin's Lymphoma, sponsored by Sanofi. Completed at 16 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-12-09.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
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.
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This study's enrollment of 100 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
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Exclusion Criteria:
Patients will receive G-CSF for 4 mornings for mobilization, followed by another dose each morning before apheresis on days that the patient is to continue apheresis (up to 8 doses total). Patients will also receive plerixafor in the evening up to a maximum of 4 doses.
Drug: Granulocyte-colony stimulating factor (G-CSF) · Drug: Plerixafor
Patients will receive G-CSF for 4 mornings for mobilization, followed by another dose each morning before apheresis on days that the patient is to continue apheresis (up to 8 doses total). Patients will also receive placebo in the evening up to a maximum of 4 doses.
Drug: Granulocyte-colony stimulating factor (G-CSF) · Drug: Placebo
10 µg/kg/day G-CSF, administered by subcutaneous (SC) injection
Also known as: GRAN®, Filgrastim
0.24 mg/kg/day subcutaneous injection
Also known as: Mozobil, AMD3100, GZ316455
0.24mg/kg/day placebo (0.9% Sodium Chloride) administered by subcutaneous injection
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
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
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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Sanofi