JPRN-jRCTs041180165进行中（未招募）2 期
Phase II study of R-CHOP and R-high-dose MTX therapy for untreated intravascular large B-cell lymphoma - PRIMEUR-IV
Yamaguchi Motoko0 个研究点目标入组 37 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
- 进行中（未招募）
- 发起方
- 入组人数
- 37
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 <= 79age old（—）
- 性别
- All
入选标准
- •1. Histologically diagnosed as intravascular large B-cell lymphoma
- •2. CD20-positive on immunohistochemistry and/or flowcytometry
- •3. Age between 20 and 79 year-old
- •4. ECOG performance status 0 to 3. PS 4 is eligible if improved PS 3 or better after corticosteroid monotherapy
- •5. No prior chemotherapy or monoclonal antibody therapy
- •6. Adequate organ functions including bone marrow, liver, kidney, cardiac and lung functions.
- •a) No active hepatitis or liver chirrhosis
- •b) Serum bilirubin less than 3mg/dl
- •c) Serum creatinine less than 2mg/dl
- •d) Left ventricular ejection fraction 50% or better
- •e) No ischemic heart disease requiring treatment, cardiomyopahty, heart failure and arrhythmia treated with anti-arrhythmics
- •f) SpO2 92% or better
- •g) WBC equal to or more than 3,000/ul, or ANC equal to or more than 1000/ul, and platelet equal to or more than 10 x 104/ul. Leukocytopenia or thrombocytopenia due to bone marrow invasion or hemophagocytic syndrome is permitted.
- •7. written informed consent
排除标准
- •1. De novo DLBCL
- •2. CNS involvement on CT and/or MRI, or CSF examination
- •3. Glaucoma requiring treatment
- •4. Diabetes mellitus requiring insulin treatment
- •5. Hypertension
- •6. Positive on HBsAg. HBV-DNA positive if HBsAb and/or HBcAb are positive
- •7. Positive on HCV Ab
- •8. Positive on HIV Ab
- •9. Interstitial pneumonitis, pulmonary fibrosis, and sever pulmonary emphysema
- •10. Sever infection
- •11. Active cancers
- •12. Past history of leukemia, lymphoma and myelodysplastic syndrome
- •13. Having treatment with major tranquilizer, antidepressant, and antimanic
- •14. Psychiatric diseases
研究者
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