EUCTR2010-022844-19-BE进行中（未招募）1 期
Randomized phase III study of a treatment driven by early PET response compared to a treatment not monitored by early PET in patients with Ann Arbor Stage III-IV or high risk IIB Hodgkin lymphoma - AHL2011
CHU de Dijon0 个研究点目标入组 810 人开始时间: 2011年7月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 810
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
- •- Patient with a first diagnosis of classical Hodgkin lymphoma according to WHO criteria excluding nodular lymphocyte predominant subtype
- •- Age of 16 to 60 years
- •- No previous treatment for Hodgkin lymphoma
- •- Ann Arbor stages:
- •IIB with mediastinum/thorax =0.33 or extra nodal localization
- •- Baseline 18-FDG PET scan (PET0) performed before any treatment with at least one hypermetabolic lesion
- •- ECOG performance status < 3
- •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
- •Pregnant or lactating women
- •Men and women of childbearing potential not practicing an adequate method of contraception during the study treatment and at least 3 months after the last study drug administration
- •Any history of cancer or cancer treatment during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma
- •Uncontrolled infectious disease, including active HBV infection defined by either detection of HBs Antigen or presence of anti HBs antibody without detectable anti HBc antibody.
- •HIV, HCV or HTLV serology positivity
- •Abnormal liver (bilirubin > 2,5 N) function unless abnormalities are due to Hodgkin lymphoma
- •Abnormal renal (Creatinin > 150 µmol/L) function unless abnormalities are due to Hodgkin lymphoma
- •Leukopenia < 2 G/L or thrombopenia <100 G/L unless abnormalities are due to Hodgkin lymphoma
- •Severe cardio-pulmonary, or metabolic disease interfering with normal application of protocol treatment:
- •oRespiratory insufficiency prohibiting bleomycin use
- •oUncontrolled diabetes mellitus leading to impossibility to perform PET scan
- •Impossibility to perform a baseline PET (PET0) before randomization and treatment beginning
研究者
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