A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of Plerixafor (0.24 mg/kg) Plus G CSF (10 µg/kg) Versus G CSF (10 µg/kg) Plus Placebo to Mobilize and Collect ≥5 × 106 CD34+ Cells/kg in Non-Hodgkin's Lymphoma (NHL) Patients for Autologous Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 100
- 试验地点
- 16
- 主要终点
- Number of patients who meet the target of ≥5 × 10^6 CD34+ cells/kg in 4 or fewer days of apheresis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
G-CSF + 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.
干预措施: Granulocyte-colony stimulating factor (G-CSF) (Drug)
G-CSF + 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.
干预措施: Plerixafor (Drug)
G-CSF + 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.
干预措施: Granulocyte-colony stimulating factor (G-CSF) (Drug)
G-CSF + 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.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of patients who meet the target of ≥5 × 10^6 CD34+ cells/kg in 4 or fewer days of apheresis
时间窗: Days 5- Day8
次要结局
- 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)