EUCTR2009-009431-30-IT进行中（未招募）不适用
PHASE III STUDY COMPARING RITUXIMAB-SUPPLEMENTED ABVD (R-ABVD) WITH ABVD FOLLOWED BY INVOLVED-FIELD RADIOTHERAPY (ABVD-RT) IN LIMITED-STAGE (STAGE I-IIA WITH NO AREAS OF BULK) HODGKIN?S LYMPHOMA. - ND
FONDAZIONE MICHELANGELO - AVANZAMENTO DELLO STUDIO E CURA DEI TUMORI0 个研究点目标入组 336 人开始时间: 2009年3月31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
- 336
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
- •History of histologically confirmed classical Hodgkin lymphoma (cHL)
- •Limited-stage disease defined as stage I or IIA with no areas of bulky disease
- •Measurable disease
- •Age >=18 years
- •Adequate bone marrow reserve (ANC >= 1,500/uL, Platelet > 100,000/uL)
- •LVEF >= 50% by MUGA scan or echocardiogram
- •Serum creatinine < 2 mg/dl, serum bilirubin < 2 mg/dl, AST or ALT <2x ULN
- •Bi-dimensionally measurable disease
- •Use of effective means of contraception
- •Signed informed consent form
- •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
- •Lymphocyte predominant HL Prior chemotherapy or radiation therapy Severe pulmonary disease as judged by the PI including COPD and asthma Presence of CNS lymphoma Concomitant malignancies or previous malignancies (exception made for adequately treated basal or squamous cell carcinoma of the skin) Active infection requiring treatment with intravenous therapy Known HIV infection Active hepatitis B or C Pregnancy or lactation and women of child bearing age who are not practicing adequate contraception
研究者
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