KCT0002087招募中未知
open–labeled, multicenter phase II study of the evaluation of single administration Pegfilgrastim once per cycle as an adjunct to R-FC (rituximab plus fludarabine and cyclophosphamide) or FC combination chemotherapy in patients with newly diagnosed or relapsed chronic lymphocytic leukemia
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1)=18 years of age, adult
- •2)Have active disase status per the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria
- •3)Have an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0,1,2
- •4)Newly diagnosed CLL or relapsed CLL patients who have no fludarabine-based chemotherapy
- •5)Planning for R-FC or FC combination chemotherapy
- •6)Adequate liver function test and favorable renal func2tion
- •- Serum creatinine < 1.5 fold of high normal limit
- •- Serum bilirubin < 1.5 fold of high normal limit
- •- ALT and alkaline phosphatase < 3 fold of high normal limit
排除标准
- •1)Prior treatment with fludaraine-based combination chemotherapy.
- •2)Concurrent enrollement in another therapeutic investigational study.
- •3)Received a hematopoietic stem cell transplantation.
- •4)History of prior malignancy.
- •5)Known history of Human Immunodeficiency Virus(HIV) or hepatitis C, or active infection with Hepatitis B or Hepatitis C.
- •6)pregnancy, breast feeding.
- •7)Any uncontrolled active systemic infection or any life-threatening illness, medical condition, or organ system dysfuction which, in the invstigator’s opinion, could compreomise the subject’s safety, interfere with the absorption or metabolism of Pegfilgrastim(Neulasta®), or put the study outcomes at undue risk.
研究者
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