EUCTR2006-004234-33-IT进行中（未招募）不适用
Intensive chemo-immunotherapy as first-line treatment in adult patients with peripheral T-cell Lymphoma PTCL - PTCL intensive chemo-immunotherapy
ISTITUTO NAZIONALE PER LA CURA TUMORI0 个研究点目标入组 111 人开始时间: 2007年2月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 111
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age 18 and 60 years for Study A patients older than 60 years are excluded because of the intensive chemotherapy and transplant procedures and 60 and 75 years for Study B patients older than 75 years are excluded because of the intensive chemo-immunotherapy program Histologically proven diagnosis of PTCL, including the following categories PTCL-U peripheral T-cell lymphoma, unspecified , AILD-T angioimmunoblastic-like T-cell lymphoma , ALKneg ALCL ALK-negative anaplastic large cell lymphoma ,intestinal T - NHL Advanced stage disease stage II-IV or stage I and aaIPI score 2 Written informed consent CD52 expression on neoplastic cells
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Histological PTCL subset other than PTCL-U, AILD-T, ALKneg-ALCL, intestinal T - NHL Central nervous system localization Positive serologic markers for human immunodeficiency virus HIV , hepatitis B virus HBV , and hepatitis C virus HCV infection Serum bilirubin levels 2 the upper normal limit Clearance of creatinine 50 ml/min DLCO 50 Ejection fraction 45 or myocardial infarction in the last 12 months Pregnancy or lactation Patient not agreeing to take adequate contraceptive measures during the study Psychiatric disease Any active, uncontrolled infection Type I hypersensivity or anaphylactic reactions to proteins drugs Active secondary malignancy
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