JPRN-jRCTs041180159已完成2 期
A Phase II trial of DA-EPOCH And Rituximab with HD-MTX therapy for newly-diagnosed DLBCL with CD5 expression (PEARL5 study)
Yamaguchi Motoko0 个研究点目标入组 45 人开始时间: 2019年3月29日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
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
- >= 20age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •(1) Histologically confirmed CD5-positive diffuse large B-cell lymphoma according to the 2008 WHO classification
- •(2) Confirmed CD20-positive and CD5-positive by immunohistochemistry and/or flow cytometry
- •(3) Ann Arbor stage: II, III, or IV
- •(4) Lymphoma cell count in peripheral blood 14 days before registration >= 10,000/mm3
- •(5) Age: 20 to 75 years old
- •(6) PS (ECOG): 0-3
- •(7) No clinical symptoms of CNS involvement
- •(8) Measureable lesion present
- •(9) No prior chemotherapy, radiotherapy, and antibody therapy
- •(10) Adequate organ function
- •(11) Written informed consent
排除标准
- •(1) History of angle-closure glaucoma
- •(2) Uncontrollable diabetes mellitus in spite of insulin therapy
- •(3) Uncontrollable hypertension
- •(4) Pleural effusion or ascites except for those with little amount
- •(5) Coronary artery disease under treatment; cardiomyopathy, heart failure, or arrhythmia treated with anti-arrhythmic
- •(6) HBs antigen positive
- •(7) HCV antibody positive
- •(8) HIV antibody positive
- •(9) Interstitial pneumonia, pulmonary fibrosis
- •(10) Severe infection
- •(11) Liver cirrhosis
- •(12) Other active malignancies; history of lymphoma, myelodysplastic syndrome, or leukemia
- •(13) Pregnant, possible pregnant, or breastfeeding woman
- •(14) Severe psychosis
- •(15) Under systemic corticosteroid therapy
- •(16) Considered as ineligible by attending physicians for other reasons
研究者
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