TCTR20170802002终止4 期
A Prospective Study on Efficacy and Safety of Filgrastim (Leuco-Plus 300) for Prevention of Chemotherapy Induced Neutropenia in Patients with Diffuse Large B-Cell Lymphoma
Apexcela Co., Ltd.0 个研究点目标入组 20 人开始时间: 2017年8月2日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
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
- 年龄范围
- 18 Years 至 0 N/A (No limit)（—）
- 性别
- All
入选标准
- •1. Male or female subjects, aged ≥ 18 years old at time of obtained consent, diagnosed with diffuse large B-cell lymphoma (DLBCL).
- •2. Have appropriate plan by physicians to start 1stline chemotherapy regimen of CHOP alone or R-CHOP together with Leuco-Plus 300 for primary prophylaxis of chemotherapy-induced neutropenia. Secondary prophylaxis with Leuco-Plus 300 will be excluded.
- •3. ECOG performance status 0-2
- •4. Patients who have consented to participate in the study in writing prior to any study procedures.
- •5. Willing and able to comply with scheduled visits and laboratory tests.
排除标准
- •1. Subjects with current grade 3 or 4 neutropenia (as per CTCAE version 4.03) and undergoing treatment with filgrastim at screening.
- •2. Patients who have previously treated with filgrastim within 4 weeks prior to screening visit.
- •3. Patients who experienced febrile neutropenia at least 1 episode prior to screening.
- •4. Diagnosed with Chronic myeloid leukemia or Myelodysplastic syndrome or other Lymphoma than DLBCL.
- •5. Hypersensitivity to Leuco-Plus 300 or to any other filgrastim.
- •6. Hypersensitivity to Escherichia coli-derived proteins
- •7. Prior bone marrow or stem cell transplant.
- •8. Patients who are pregnant or breastfeeding.
- •9. Women of childbearing potential who are not willing to use an effective method of birth control.
研究者
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