CTRI/2018/04/013221已完成3 期
A randomised, controlled, comparative, open-label, multicenter study on the safety and efficacy of PEG Neutrogen and Neulastim in prevention of chemotherapy-induced neutropenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male or female patients aged between 18 â?? 65 years.
- •2. Patients with histologically confirmed tumors (breast
- •cancer, small cell lung cancer, Non-Hodgkinâ??s
- •3. Patients who are planned to receive myelosupresive chemotherapy regimen (which is known to induce severe neutropenia).
- •4. Patients with baseline ANC of >=1.5 x 109/L and plateletcount >= 100 x 109/L.
- •5. Patients with hemoglobin >=9 g/dl; WBC >=3,000/cu mm.
- •6. Patients with albumin >= 3.0 g/dl.
- •7. Performance status as per ECOG (Eastern Cooperative Group) score 0, 1 or 2.
- •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, ymophoblastic 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.
- •5. 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/ concurrent exposure to radio therapy and surgery.
- •8. Abnormal cardiovascular, hepatic and renal laboratory parameters that are deemed to be clinically significant as per investigator.
- •9. Known cases of sickle cell anemia.
- •10. History of AIDS, or HIV positive, active hepatitis and active tuberculosis.
研究者
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