CTRI/2026/02/103432尚未招募Unknown
A phase IV, prospective, single arm, open-label, multicentre study to assess the safety and efficacy of PEG-Neutrogen (pegfilgrastim) in prevention of chemotherapy-induced neutropenia
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
研究概览
简要总结
A phase IV, prospective, single arm, open-label, multicentre study to assess the safety and efficacy of PEG-Neutrogen (pegfilgrastim) in prevention of chemotherapy-induced neutropenia.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients aged between 18 to 65 years.
- •Patients with histologically confirmed tumors (breast cancer, lung cancer, Non-Hodgkin Lymphoma, ovarian cancer, cervical cancer).
- •3.Patients who are planned to receive myelosupresive chemotherapy regimen (which is known to induce severe neutropenia).
- •Patients with baseline ANC of greaterthan1.5 x 109/L and platelet count greaterthan 100 x 109/L.
- •5.Patients with hemoglobin greaterthan9 g/dl; WBC greaterthan3,000/cu mm.
- •6.Patients with albumin greaterthan 3.0 g/dl.
- •7.Performance status as per ECOG (Eastern Cooperative Group) score 0, 1 or
- •8.Patients with life expectancy more than 2 months.
- •9.Patients scheduled to undergo chemotherapy at least for 3 cycles.
- •10.Patients who are available for 15 days during each post chemotherapy cycle.
- •11.Patients who are willing to give the consent.
排除标准
- •1.Pregnant and lactating women or patients planning to become pregnant.
- •2.Known allergic reactions to study medications.
- •3.Patients with myelodysplastic syndrome, acute lymphoblastic or myeloblastic leukemia, lymophoblastic lymphoma, myeloma or severe pneumonia, hypotension, multi organ dysfunction.
- •4.Patients with prior exposure to G-CSF or GM-CSF or to its pegylated products.
- •Myelotoxic concomitant treatment such as chloramphenicol, sulphmethoxarate, immunomodulating agents, interferons during 10 days before randomization.
- •6.Central nervous system metastases.
- •7.Patients who had an immediate or concurrent exposure to radio therapy and surgery.
- •Abnormal cardiovascular, hepatic and renal laboratory parameters that are deemed to be clinically significant as per investigator.
- •10.History of AIDS, or HIV positive, active hepatitis and active tuberculosis.
研究者
Dr Lakshmi Priyadarshini
HCG City Cancer Centre
研究点 (1)
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