JPRN-UMIN000013540已完成2 期
A study investigating the efficacy and safety of CNS prophylaxis with R-CHOP and high-dose methotrexate in patients with de novo diffuse large B-cell lymphoma who have high risk for CNS relapse. - A study investigating the efficacy and safety of CNS prophylaxis with R-CHOP and high-dose methotrexate in patients with de novo diffuse large B-cell lymphoma who have high risk for CNS relapse.
Department of Hematology and Oncology, Osaka University Graduate School of Medicine0 个研究点目标入组 100 人开始时间: 2014年3月28日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
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
- 20years-old 至 ot applicable(—)
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Primary CNS lymphoma (include intraocular lymphoma) or lymphoma with cns involvement on CT and/or MRI, or CSF examination on admission 2. Intravascular lymphoma, primary effusion lymphoma, mediastinal large B-cell lymphoma 3. Primary testicular lymphoma 4. Patients with peripheral bood involvement of lymphoma on admission 5. Prior treatment for lymphoma except lymph node biopsy and local radiation therapy 6. Presence of fluid in the third space (e.g. pleural effusions) 7. Patients with pre-existing renal insufficiency 8. Patients with another active malignancy 9. Patients with serious complications (malignant hypertension, congestive heart failure, coronary insufficiency, a new onset of myocardial infarction within 3 months, uncontrolled hyperglycemia, pulmonary fibrosis, interstitial pneumonia, etc) 10. Severe psychosis 11. Presence of uncontrollable active infection 12. Patients with allergy to drug used for conditioning regimen 13. Positive for HIV antibody, HCV antibody or HTLV-1 antibody 14. HBs antigen positive patients judged unfeasible to participate in this protocol in spite of the administration of antiviral drugs 15. Patients who are pregnant or lactating 16. Without any written consent from patients 17. Inadequate patients to enroll judged by investigators
研究者
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