NCT02044276已完成3 期
A Randomized, Phase IIIB, Open-label, Two-arm, Multicenter, comparatiVe Study on Efficacy and Safety of Lipegfilgrastim (Lonquex, TEVA) in Comparison to Pegfilgrastim (Neulasta(R), Amgen) in Elderly Patients With Aggressive B Cell Non-HOdgkin Lymphomas at hIgh Risk for R-CHOP-21-inDuced Neutropenia - AVOID Neutropenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 60
- 主要终点
- Duration of severe neutropenia (DSN) ANC <0.5 * 10^9/L
研究概览
简要总结
The primary objective of the study is to demonstrate non-inferiority of lipegfilgrastim to pegfilgrastim for the duration of severe neutropenia in the first cycle of chemotherapy.
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
- None
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated Independent Ethics Committee (IEC)-approved written informed consent
- •Age ≥65 years and ≤85 years
- •Histological documentation of aggressive B cell NHL
- •Planned to receive systemic anticancer therapy with at least 6 cycles of R-CHOP-21, according to local standards
- •ECOG score ≤2
- •Life expectancy of at least 3 months
- •Adequate bone marrow, renal and hepatic function within 14 days before start of chemotherapy
- •The patient is capable of understanding and complying with parameters as outlined in the protocol
- •Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the treatment and for 30 days after discontinuation of study drug.
- •The patient, if a man, is surgically sterile, or, if capable of producing offspring, is currently using an approved method of birth control and agrees to continued use of this method for the duration of the treatment (and for 90 days after taking the last dose of study
- •Other Criteria apply, please contact the investigator for more information
排除标准
- •Participation in a clinical study within 30 days before randomization
- •Any chemotherapy within the last 3 months before start of chemotherapy. A prephase to reduce tumor burden prior to start of R-CHOP is allowed.
- •The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of chemotherapy.
- •Active cardiac disease
- •Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of chemotherapy.
- •Ongoing infection, known history of human immunodeficiency virus (HIV) infection, tuberculosis, or chronic hepatitis B or C.
- •Patients with evidence or history of bleeding diathesis.
- •Non-healing wound, ulcer or bone fracture.
- •Renal failure requiring hemo- or peritoneal dialysis.
- •Any conditions that may interfere with the patient's participation in the study or evaluation of the study results.
- •Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
- •Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study.
- •Treatment with lithium at screening or planned during the study.
- •Other Criteria apply, please contact the investigator for more information
研究组 & 干预措施
lipegfilgrastim.
Experimental
subcutaneous (SC) injection of 6 mg lipegfilgrastim
干预措施: lipegfilgrastim (Drug)
pegfilgrastim
Active Comparator
SC injection of 6 mg pegfilgrastim
干预措施: pegfilgrastim (Drug)
结局指标
主要结局
Duration of severe neutropenia (DSN) ANC <0.5 * 10^9/L
时间窗: 3 weeks
Grade 4 neutropenia measured in days
次要结局
- Incidence of FN(18 weeks)
- Incidence of very severe neutropenia(3 weeks)
- Incidence of febrile neutropenia (FN) (strict definition)(18 weeks)
- Incidence of infections(18 weeks)
- Summary of participants with adverse events(9 Months)
- Time to ANC recovery(3 weeks)
研究者
研究点 (60)
Loading locations...
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