EUCTR2007-003467-48-DE进行中（未招募）不适用
A randomized phase II study of prednisone, vinblastine, doxorubicin, and gemcitabine in patients with intermediate stage Hodgkin's lymphoma - PVAG-14 pilot
niversität zu Köln0 个研究点目标入组 100 人开始时间: 2007年10月2日最近更新:
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
- 100
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
- •1. Histologically confirmed diagnosis of Hodgkin's lymphoma
- •2. Clinical Stage IA, IB, IIA with at least one of the riskfactors a-d given below, or Clinical Stage IIB with one or both riskfactors c-d given below
- •Riskfactors:a) Large mediastinal mass (= 1/3 of the greatest thorax diameter as measured by chest x-ray), b) Extranodal involvement, c) High erythrocyte sedimentation rate (= 50 mm/h in patients without B-symptoms, = 30 mm/h in patients with B-symptoms), d)Three or more involved lymph node areas
- •3. No prior therapy for Hodgkin's lymphoma
- •4. Age: 18-60 years
- •5. Signed informed consent with understanding of the study procedures and the investigational nature of the study.
- •6. Patient agrees that personal data and tissue samples are provided to the GHSG (protection of privacy as defined by law will be ensured)
- •7. Life expectancy > 3 months according to investigator judgement.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Incomplete diagnosis of stage of disease
- •2. Prior or concurrent disease which prevents treatment according to protocol
- •3. HD as composite lymphoma
- •4. Prior chemotherapy or radiation
- •5. Malignant disease within the last 5 years
- •6. Pregnancy, lactation
- •7. WHO performance index > 2
- •8. Long-term ingestion of corticosteroids (e.g. for chronic polyarthritis) or antineoplastic drugs (e.g. methotrexate)
- •9. Non compliance
- •10. Refusal of blood products during treatment, epilepsy, drug dependency, change of residence abroad, prior cerebral injury or similar circumstances which appear to make protocol treatment or long-term follow-up impossible
- •11. Antiepileptic treatment
- •12. General intolerance of any protocol medication
研究者
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