EUCTR2004-001558-10-CZ进行中（未招募）不适用
BEACOPP (4 cycles escalated + 4 cycles baseline) versus ABVD (8 cycles) in stage III & IV Hodgkin’s lymphoma
European Organisation for Research and Treatment of Cancer0 个研究点目标入组 550 人开始时间: 2006年12月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 550
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
- •- Histologically documented Hodgkin’s lymphoma/disease, except for the subtype lymphocyte predominant, nodular type (nodular paragranuloma)
- •- Clinical stage III or IV
- •- Presence of at least one bi-dimensionally measurable target lesion ; patients with extranodal disease only will be eligible if they have at least one bi-dimensionally measurable extranodal lesion.
- •- Patients with an International Prognostic Score (IPS) ?3
- •- Age 16-60 years
- •- WHO performance status grades 0, 1, or 2
- •- Adequate liver (bilirubin = 2.5 x normal) and renal (creatinine = 150 ?mol/L or = 2.0 mg/dL) function, unless abnormalities are due to HD
- •- Leukocytes >2.0*109/l and platelets >100*109/l
- •Are the trial subjects under 18? yes
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Patients with no nodal or visceral measurable disease.
- •- Prior therapy for Hodgkin's disease
- •- Potentially childbearing patients without effective contraception
- •- Pregnant or lactating women
- •- Concomitant or previous malignancies other than basal cell skin tumors or in situ uterine cervix carcinoma
- •- Severe cardio-pulmonary, neurological or metabolic disease, interfering with normal life expectancy or normal application of protocol treatment (patients with LEVF<50 and RF<30% are not eligible)
- •- Severe active infection
- •- Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •- Known HIV or HTLV1 positivity
- •- History of uncontrolled HBV infection defined as presence of HBS antigen or absence of HBS antigen but presence of anti-HBc antibody without anti-HBS antibody
研究者
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