JPRN-jRCTs031180103进行中（未招募）2 期
JCOG0908: Randomized phase II study of biweekly R-CHOP versus biweekly R-CHOP followed by CHASER as induction therapy for high-dose chemotherapy, LEED, and autologous stem-cell transplantation in poor-risk diffuse large B-cell lymphoma - DLBCL-bi-R-CHOP/CHASER-LEED-rP2
YAMAMOTO Kazuhito0 个研究点目标入组 70 人开始时间: 2019年2月4日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
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 <= 65age old（—）
- 性别
- All
入选标准
- •1) Histologically confirmed diffuse large B-cell lymphoma, including subtypes, lymphomatoid granulomatosis Grade 3, and primary mediastinal (thymic) large B-cell lymphoma (except for intravascular large B-cell lymphoma)
- •2) Positive for CD20 in lymphoma cells
- •3) Aged 20 to 65 years old
- •4) Performance status (PS) of 0-2 on ECOG(Eastern Cooperative Oncology Group) scale
- •5) Stage III or IV disease, or stage II with bulky disease
- •6) High-intermediate or high risk group on AA-IPI (Age-adjusted International Prognostic Index) score
- •7) Lymphoma cells in peripheral blood <=10,000/mm3
- •8) No testicular or central nervous system involvement
- •9) Having measurable lesions
- •10) No previous history of chemotherapy, radiation therapy, interferon and/or antibody
- •11) Adequate hematological and major organ function
- •12) Written informed consent
排除标准
- •1) History of glaucoma
- •2) Diabetes mellitus regularly treated with insulin or uncontrollable diabetes mellitus
- •3) Uncontrollable hypertension
- •4) Serious cardiac conditions such as coronary disease, myocardiopathy and/or heart failure that requires treatment, and/or arrhythmia treated with antiarrhythmic
- •5) Positive test for HBs antigen
- •6) Positive test for HCV antibody
- •7) Positive test for HIV antibody
- •8) Interstitial pneumonia, pulmonary fibrosis or severe pulmonary emphysema
- •9) Other active malignancies
- •10) Severe infection that requires systemic therapy
- •11) Fever above 38 degrees Celsius except related to B symptoms
- •12) Pregnant, possible pregnant, or breastfeeding woman
- •13) Psychological disease or condition that precludes participation in clinical trial
研究者
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