Prospective, multi-centric, open label, two arm, parallel group, active control, randomized, comparative clinical study to evaluate efficacy and safety of R-TPR-029/ Neulasta® (Neulastim®) when given subcutaneously in patients with Chemotherapy Induced Neutropenia.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 105
- 试验地点
- 16
- 主要终点
- Duration of Grade 4 neutropenia will be measured in days in patients receiving R-TPR-029 / Neulasta® (Neulastim®)
研究概览
简要总结
Neutropenia is the most serious hematologic toxicity of cancer chemotherapy, often limiting the doses of chemotherapy that can be tolerated. Chemotherapy predisposes patients with cancer to infections both by suppressing the production of neutrophils and by cytotoxic effects on the cells that line the alimentary tract. Neutrophils are the first line of defense against infection as the first cellular component of the inflammatory response and a key component of innate immunity. Neutropenic complications associated with myelosuppressive chemotherapy are a significant cause of morbidity and mortality, possibly compromised treatment outcomes, and excessive healthcare costs.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
G-CSF is a glycoprotein which stimulates the survival, proliferation, differentiation and function of neutrophil granulocyte progenitor cells and mature neutrophils. The two forms of recombinant human G-CSF in clinical use (filgrastim and pegfilgrastim) are potent stimulants of neutrophil granulopoiesis and are indicated in reduction of duration and incidence of FN in patients treated with cytotoxic chemotherapy for malignancy. Pegfilgrastim is a sustained duration form of filgrastim, due to decreased renal clearance.
R-TPR-029 has been developed by RLS as a similar biological medicinal product (PEG-GCSF) to Neulasta® (Neulastim®) and is intended to be used in patients with chemotherapy-induced neutropenia. The proposed study will be conducted in compliance with the protocol, Good Clinical Practice (GCP) and applicable regulatory requirements
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adult patients of either sex in the age group of 18 to 65 years 2.Patients scheduled to receive myelosuppressive chemotherapy regimens.
- •3.Any previous chemotherapy exposure should have been completed >3 weeks before randomization and no more than 1 cycle of chemotherapy for the existing disease is allowed before randomization into the present study.
- •4.Patients with high risk or intermediate risk of developing chemotherapy-induced febrile neutropenia as per NCCN guidelines.
- •5.Patients planned and eligible to undergo at least 4 cycles of chemotherapy after randomization.
- •6.Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •7.Adequate hematologic function 8.Estimated life expectancy >6 months 9.Females of childbearing potential should be willing to use an approved method of contraception.
- •10.Able to understand the study procedures, the risks involved, willing to provide written Informed Consent, and able to adhere to study schedules and requirements.
排除标准
- •1.Known active acute or chronic infection 2.Pregnant or breastfeeding women, and women not practicing effective contraception.
- •3.Known hypersensitivity to the active ingredient or other product constituents.
- •4.Patients with history of radiation within 4 weeks before the first cycle of chemotherapy in the study 5.Patient is on bleomycin- or carbazitaxel-containing chemotherapy regimen 6.Patient with body weight 45 kg 7.Previous bone marrow or stem-cell transplantation 8.Diagnosis of concurrent second malignancy 9.Serious inter-current chronic or acute illness 10.Systemic autoimmune disorder and/or chronic use of immunosuppressive agents during the 6 weeks prior to the first cycle of chemotherapy in the study 11.History of chemotherapy causing delayed myelosuppression 12.Concurrent use of other granulocyte colony stimulating growth factors 13.Received prophylactic antibiotics within the preceding 6 weeks.
- •14.Patients with neuropathy of grade 2 or higher.
- •15.Impaired renal or hepatic function.
- •16.Any other medical condition, which in opinion of the investigator, may affect patient’s participation in the study 17.Patient’s participation in another clinical trial 90 days prior to administration of IP.
结局指标
主要结局
Duration of Grade 4 neutropenia will be measured in days in patients receiving R-TPR-029 / Neulasta® (Neulastim®)
时间窗: Duration of Grade 4 neutropenia will be measured in days in patients receiving R-TPR-029 / Neulasta® (Neulastim®)
次要结局
- •Incidence of Grade 4 neutropenia .(•The incidence of febrile neutropenia.)