Targeted BEACOPP Variants in Patients With Newly Diagnosed Advanced Classical Hodgkin Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Complete remission rate (CR/CRr) as final treatment outcome after completion of treatment
研究概览
简要总结
The Purpose of this trial is:
- to determine complete response rate (CRR) after six cycles of chemotherapy
- to determine complete remission rate (CR/CRr) as final treatment outcome after completion of treatment
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
- None
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 proven classical Hodgkin lymphoma
- •First diagnosis, no previous treatment, age: 18-60 years
- •Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV disease
排除标准
- •Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)
- •Previous malignancy
- •Prior chemotherapy or radiation
研究组 & 干预措施
BrECAPP
modified BEACOPP by omitting Bleomycin and adding Brentuximab Vedotin
干预措施: Etoposide (Drug)
BrECAPP
modified BEACOPP by omitting Bleomycin and adding Brentuximab Vedotin
干预措施: Cyclophosphamide (Drug)
BrECAPP
modified BEACOPP by omitting Bleomycin and adding Brentuximab Vedotin
干预措施: Doxorubicin (Drug)
BrECAPP
modified BEACOPP by omitting Bleomycin and adding Brentuximab Vedotin
干预措施: Prednisone (Drug)
BrECAPP
modified BEACOPP by omitting Bleomycin and adding Brentuximab Vedotin
干预措施: Procarbazine (Drug)
BrECAPP
modified BEACOPP by omitting Bleomycin and adding Brentuximab Vedotin
干预措施: Brentuximab Vedotin (Drug)
BrECADD
modified BEACOPP by omitting Bleomycin, Procarbazine and Prednisone and adding Brentuximab Vedotin, Dacarbazine and Dexamethasone
干预措施: Etoposide (Drug)
BrECADD
modified BEACOPP by omitting Bleomycin, Procarbazine and Prednisone and adding Brentuximab Vedotin, Dacarbazine and Dexamethasone
干预措施: Cyclophosphamide (Drug)
BrECADD
modified BEACOPP by omitting Bleomycin, Procarbazine and Prednisone and adding Brentuximab Vedotin, Dacarbazine and Dexamethasone
干预措施: Doxorubicin (Drug)
BrECADD
modified BEACOPP by omitting Bleomycin, Procarbazine and Prednisone and adding Brentuximab Vedotin, Dacarbazine and Dexamethasone
干预措施: Dexamethasone (Drug)
BrECADD
modified BEACOPP by omitting Bleomycin, Procarbazine and Prednisone and adding Brentuximab Vedotin, Dacarbazine and Dexamethasone
干预措施: Dacarbazine (Drug)
BrECADD
modified BEACOPP by omitting Bleomycin, Procarbazine and Prednisone and adding Brentuximab Vedotin, Dacarbazine and Dexamethasone
干预措施: Brentuximab Vedotin (Drug)
结局指标
主要结局
Complete remission rate (CR/CRr) as final treatment outcome after completion of treatment
时间窗: 18 weeks
Response rate (RR) after six cycles of chemotherapy
时间窗: 18 weeks
次要结局
- Adverse event rate(2 years)
- Relative dose intensity(18 weeks)
- Progression Free Survival (PFS)(2 years)
- Dose reduction rate(18 weeks)
- Overall survival (OS)(2 years)
研究者
Prof. Dr. Peter Borchmann
Prof.
University of Cologne