Expanded Access Program of Pegfilgrastim in Patients With Non-Hodgkin Lymphoma (NHL)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 53
- 主要终点
- Percentage of Participants with Febrile Neutropenia (Absolute Neutrophil Count [ANC] <0.5x10^9/L and Temperature ≥38 degrees Celsius) And/Or Grade IV Neutropenia (ANC<0.5x10^9/L) in Cycle 1
研究概览
简要总结
This study will assess the prophylactic effect of pegfilgrastim (Neulastim) on febrile and/or Grade IV neutropenia in participants receiving chemotherapy (CT) or immunochemotherapy (ICT) as first or second line treatment for NHL. Pegfilgrastim will be administered at a fixed dose of 6 milligrams (mg) subcutaneously 24 hours after the last dose of CT or ICT in each treatment cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NHL supported by an Immunohistochemical report
- •Eastern Cooperative Oncology Group (ECOG) performance status greater than or equal to (>/=) 2
- •Total serum bilirubin less than (<) 2 times upper limit of normal (ULN)
- •Absolute neutrophil count (ANC) greater than (>) 2 x10^9 per liter (/L)
排除标准
- •Bone marrow compromised > 10 percent (%)
- •Any malignant myeloid condition
- •Active infections requiring systemic anti-infectious therapies (antibiotics, antifungal drugs, antiviral drugs) within 72 hours prior to CT or ICT initiation
- •Known hypersensitivity reactions to Escherichia coli derived products
- •Pregnant or nursing participants. Women with childbearing potential should use a safe contraceptive method
研究组 & 干预措施
Pegfilgrastim
Participants will receive CT or ICT for 6 cycles on Days 1-6, as per standard of care. Protocol does not specify any choice of CT or ICT drugs. Participants will receive pegfilgrastim at a fixed dose of 6 mg subcutaneously, 24 hours after the last dose of CT or ICT in each treatment cycle. CT or ICT cycles of 21 days, as per standard of care.
干预措施: Chemotherapy (Drug)
Pegfilgrastim
Participants will receive CT or ICT for 6 cycles on Days 1-6, as per standard of care. Protocol does not specify any choice of CT or ICT drugs. Participants will receive pegfilgrastim at a fixed dose of 6 mg subcutaneously, 24 hours after the last dose of CT or ICT in each treatment cycle. CT or ICT cycles of 21 days, as per standard of care.
干预措施: Immunochemotherapy (Drug)
Pegfilgrastim
Participants will receive CT or ICT for 6 cycles on Days 1-6, as per standard of care. Protocol does not specify any choice of CT or ICT drugs. Participants will receive pegfilgrastim at a fixed dose of 6 mg subcutaneously, 24 hours after the last dose of CT or ICT in each treatment cycle. CT or ICT cycles of 21 days, as per standard of care.
干预措施: Pegfilgrastim (Drug)
结局指标
主要结局
Percentage of Participants with Febrile Neutropenia (Absolute Neutrophil Count [ANC] <0.5x10^9/L and Temperature ≥38 degrees Celsius) And/Or Grade IV Neutropenia (ANC<0.5x10^9/L) in Cycle 1
时间窗: Cycle 1 (Up to 21 days)
次要结局
- Percentage of Participants with Febrile Neutropenia (ANC <0.5x10^9/L and temperature ≥38 degrees Celsius) And/Or Grade IV Neutropenia (ANC<0.5x10^9/L) in Cycles 2 to 6(Cycles 2 to 6 (Up to 105 days))
- Percentage of Participants with Adverse Events(up to approximately 1.5 years)