2024-518022-33-00已完成3 期
HD21 for advanced stages - Treatment optimization trial in the first-line treatment of advanced stage Hodgkin lymphoma; comparison of 4-6 cycles of escalated BEACOPP with 4-6 cycles of BrECADD
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,320
- 试验地点
- 162
- 主要终点
- Randomized main study: Treatment-related morbidity (TRMB)
研究概览
简要总结
Primary objective of the trial is to demonstrate reduced toxicity of the BrECADD treatment compared to escalated BEACOPP treatment measured by treatment-related morbidity (TRMB). Co-primary objective is to further demonstrate non-inferior efficacy of 6 cycles BrECADD compared to 6 cycles of escalated BEACOPP, each followed by radiotherapy to PET-positive residual lesions, in terms of progression-free survival.
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Histologically proven classical Hodgkin lymphoma
- •First diagnosis, no previous treatment
- •Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV
- •Randomized main study: 18 to 60 years of age
- •Cohort of older patients: 61 to 75 years of age
排除标准
- •Composite lymphoma or nodular lymphocyte-predominat Hodgkin lymphoma
- •Previous malignancy (exeptions: basalioma, carcinoma in situ of the cervix uteri, completely resected melanoma TNMpT1)
- •Prior chemotherapy or radiotherapy (prephase is allowed as outlined in the protocol)
- •Current disease which precludes protocol treatment
- •Pregnancy, lactation
- •Non-Compliance
结局指标
主要结局
Randomized main study: Treatment-related morbidity (TRMB)
Randomized main study: Treatment-related morbidity (TRMB)
Randomized main study: Progression-free survival (PFS)
Randomized main study: Progression-free survival (PFS)
Cohort of older patients: Complete remission (CR) rate after chemotherapy
Cohort of older patients: Complete remission (CR) rate after chemotherapy
次要结局
- Randomized main study: Second malignancies
- Randomized main study: Quality of life (QoL)
- Randomized main study: Frequency of adverse events
- Randomized main study: Tumor response (CR rate)
- Randomized main study: Overall survival (OS)
- Randomized main study: Infertility rate at 1 year
- Randomized main study: Therapy adherence
- Randomized main study: Event-free Survival (EFS)
- Cohort of older Patients: TRMB
- Cohort of older patients: PFS
- Cohort of older patients: OS
- Cohort of older patients: Time to progression (PFSHL) and HL-specific survival (OSHL)
研究者
Peter Borchmann
Scientific
University Of Cologne
研究点 (162)
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