Non-Hodgkin's Lymphoma
Conditions
Keywords
hematopoietic stem cell transplantation
Brief summary
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.
Detailed description
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.
Interventions
10 µg/kg/day G-CSF, administered by subcutaneous (SC) injection
DRUGPlerixafor
0.24 mg/kg/day subcutaneous injection
DRUGPlacebo
0.24mg/kg/day placebo (0.9% Sodium Chloride) administered by subcutaneous injection
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Has a biopsy-confirmed diagnosis of NHL * Is in first or second complete remission or partial remission, defined for the purpose of this study as complete or partial response following first- or second-line therapy * Treatment with an autologous peripheral HSC transplant is planned and the patient is eligible for autologous transplantation * Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Has recovered from all acute toxic effects of prior chemotherapy or other cancer treatment. * Has an actual body weight \<175% of their ideal body weight (IBW) * The patient agrees to use a highly effective method of contraception from Day 1 through ≥3 months following plerixafor treatment.
Exclusion criteria
* Concurrent serious illness and pathological conditions * Has undergone previous HSC collections or collection attempt * Has had any autologous or allogeneic HSC transplant * Has active central nervous system (CNS) involvement * Bone marrow lymphoma cells involvement \>20%, as assessed by bone marrow biopsy within 4 months before signing the ICF * Has received radiation therapy to the pelvis * Has a diagnosis of all leukemias including any type of CLL * Active infection * Pregnant or nursing * Anticipated post-transplant chemotherapy and/or radiation therapy below the diaphragm * Received any prior radio-immunotherapy * Prior 1,3-bis(2-chloroethyl)-1-nitroso-urea (BCNU) within 6 weeks prior to first dose of G-CSF * Prior cancer therapy, other investigational therapy within 4 weeks prior to first dose of G-CSF * Prior granulocyte/macrophage-colony stimulating factor (GM-CSF) or pegfilgrastim within 3 weeks prior to the first dose of G-CSF * Prior G-CSF within 2 weeks prior to the first dose of G-CSF * Inadequate organ funtion evidenced by unacceptable laboratory result
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients who meet the target of ≥5 × 10^6 CD34+ cells/kg in 4 or fewer days of apheresis | Days 5- Day8 |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients who achieve ≥2 × 10^6 CD34+ cells/kg within 4 or fewer days of apheresis | Day 5 - Day 8 |
| Number of days of apheresis to collect ≥2 × 10^6 CD34+ cells/kg | 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 | Up to achieve the target of collecting ≥5 × 10^6 CD34+ cells/kg |
| Total number of CD34+ cells collected | Day 5 - Day 8 |
| Number of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) | from signed Informed Consent Form (ICF) to 30 days post-transplant and then ongoing as needed |
| Maximum plasma concentration (Cmax) | Day 4 - Day 5 |
| Time to reach Cmax (Tmax) | Day 4 - Day 5 |
| Area Under the Curve 0 to 10 hours post-dose (AUC0-10) | Day 4 - Day 5 |
| Time from transplantation to neutrophil and platelet (PLT) engraftment | up to 30 days post-transplantation |
| Area Under the Curve (AUC) | Day 4 - Day 5 |
| Percentage of extrapolation of AUC (AUCext) | Day 4 - Day 5 |
| Half life (T1/2) | Day 4 - Day 5 |
| Volume of distribution (Vz/F) | Day 4 - Day 5 |
| Total body clearance (CL/F) | Day 4 - Day 5 |
| Peripheral blood CD34+ cell counts (Pharmacodynamic analysis) | 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 | Day 5 - Day 8 |
| Area Under the Curve 0 to last observed concentration (AUClast) | Day 4 - Day 5 |
Countries
China
Outcome results
None listed