Evaluation of Plerixafor Plus G-CSF to Mobilize and Collect 5×10^6CD34+ Cells/kg in Non-Hodgkin's Lymphoma (NHL) Patients for Autologous Transplantation
Phase 3
Completed
- Conditions
- Non-Hodgkin's Lymphoma
- Interventions
- Registration Number
- NCT01767714
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description G-CSF + plerixafor 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 plerixafor in the evening up to a maximum of 4 doses. G-CSF + Placebo Placebo 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. G-CSF + plerixafor Granulocyte-colony stimulating factor (G-CSF) 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. G-CSF + Placebo Granulocyte-colony stimulating factor (G-CSF) 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Volume of distribution (Vz/F) Day 4 - Day 5 Peripheral blood CD34+ cell counts (Pharmacodynamic analysis) Day 4 - Day 5 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 Area Under the Curve (AUC) Day 4 - Day 5 Percentage of extrapolation of AUC (AUCext) Day 4 - Day 5 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 Total number of CD34+ cells collected Day 5 - Day 8 Time to reach Cmax (Tmax) Day 4 - Day 5 Time from transplantation to neutrophil and platelet (PLT) engraftment up to 30 days post-transplantation Area Under the Curve 0 to last observed concentration (AUClast) Day 4 - Day 5 Area Under the Curve 0 to 10 hours post-dose (AUC0-10) Day 4 - Day 5 Total body clearance (CL/F) Day 4 - Day 5 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 Half life (T1/2) 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
Trial Locations
- Locations (16)
Investigational Site Number 156001
🇨🇳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 156018
🇨🇳Nanjing, China
Investigational Site Number 156009
🇨🇳Shanghai, China
Investigational Site Number 156010
🇨🇳Suzhou, China
Investigational Site Number 156017
🇨🇳Beijing, China
Investigational Site Number 156005
🇨🇳Beijing, China
Investigational Site Number 156002
🇨🇳Beijing, China
Investigational Site Number 156011
🇨🇳Hangzhou, China
Investigational Site Number 156008
🇨🇳Tianjin, China
Investigational Site Number 156013
🇨🇳Wuhan, China
Investigational Site Number 156015
🇨🇳Xi'An, China
Investigational Site Number 156022
🇨🇳Zhengzhou, China