NCT00512980终止2 期
A Randomized Phase II Study of Prednisone, Vinblastine, Doxorubicin, and Gemcitabine in Patients With Intermediate Stage Hodgkin's Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 试验地点
- 1
研究概览
简要总结
A randomized phase II study of prednisone, vinblastine, doxorubicin, and gemcitabine in patients with intermediate stage Hodgkin's lymphoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of Hodgkin's lymphoma
- •Clinical Stage IA, IB, IIA with at least one of the risk factors a-d given below
- •Clinical Stage IIB with one or both risk factors c-d given below risk factors:
- •Large mediastinal mass (≥ 1/3 of the greatest thorax diameter as measured by chest x-ray)
- •Extranodal involvement
- •High erythrocyte sedimentation rate (≥ 50 mm/h in patients without B-symptoms, ≥ 30 mm/h in patients with B-symptoms)
- •Three or more involved lymph node areas
- •No prior therapy for Hodgkin's lymphoma (exception: pre-phase treatment with corticosteroids and vinca-alkaloids for a maximum of seven days may not preclude trial participation if clinically indicated and all staging examinations have been performed; all forms of prior radiotherapy preclude trial participation)
- •Age: 18-60 years
- •Signed informed consent with understanding of the study procedures and the investigational nature of the study
- •Patient agrees that personal data and tissue samples are provided to the GHSG (protection of privacy as defined by law will be ensured)
- •Life expectancy > 3 months according to investigator judgement.
排除标准
- •Incomplete diagnosis of stage of disease
- •Prior or concurrent disease which prevents treatment according to protocol In particular the following contraindications:
- •Chronic obstructive pulmonary disease with global insufficiency
- •Symptomatic coronary heart disease
- •Cardiomyopathy or cardiac insufficiency (NYHA value of EF < 50% or FS < 25%)
- •Serious uncontrolled hypertension
- •Uncontrollable infection
- •Leucocyte concentration < 3.000/mm3 or thrombocyte concentration < 100.000/mm3
- •Creatinin clearance < 60 ml/min
- •Bilirubin > 2 mg/dl or GPT > 100 U/l or GOT > 100 U/I (exception: elevated values of Hodgkin's disease liver involvement)
- •HIV-Infection according to HIV test
- •Chronic or acute Hepatitis
- •HD as composite lymphoma
- •Prior chemotherapy or radiation
- •Malignant disease within the last 5 years (exceptions: basalioma, carcinoma in situ of the cervix uteri, completely resected melanoma TNMpT1)
- •Pregnancy, lactation, positive pregnancy test
- •Refusal to use effective contraception
- •WHO performance index > 2
- •Long-term ingestion of corticosteroids (e.g. for chronic polyarthritis) or antineoplastic drugs (e.g. methotrexate)
- •Patient's lack of accountability, inability to appreciate the nature, meaning and consequences of the trial and to formulate his/her own wishes correspondingly
- •Non compliance: 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
- •Antiepileptic treatment
- •General intolerance of any protocol medication
- •Any contraindication for study medication according to the summaries of product information
- •Simultaneous participation in another clinical
- •Institutionalization by law
- •Relation of dependence with the sponsor's representative / trialist
研究组 & 干预措施
1
Active Comparator
干预措施: prednisone (Drug)
1
Active Comparator
干预措施: vinblastine (Drug)
1
Active Comparator
干预措施: doxorubicin (Drug)
1
Active Comparator
干预措施: gemcitabine (Drug)
2
Active Comparator
干预措施: prednisone (Drug)
2
Active Comparator
干预措施: vinblastine (Drug)
2
Active Comparator
干预措施: doxorubicin (Drug)
2
Active Comparator
干预措施: gemcitabine (Drug)
研究者
Prof. Dr. Andreas Engert
Prof.
University of Cologne
研究点 (1)
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