Nivolumab and AVD in Early-stage Unfavorable Classical Hodgkin Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Complete Remission Rate
研究概览
简要总结
The aim of the trial is to improve first-line treatment for early unfavorable cHL by introduction of the anti-PD-1 antibody Nivolumab with a truncated standard chemotherapy (AVD).
The primary objective is to show efficacy of the two experimental treatment strategies. Secondary objectives are to further evaluate efficacy, show safety and feasibility and perform correlative studies.
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 HL
- •First diagnosis, no previous treatment
- •Age: 18-60 years
- •Stage I, IIA with risk factors a-d, IIB with RF c-d:
- •large mediastinal mass
- •extranodal lesions
- •elevated ESR
- •≥ 3 nodal areas confirmed by central review.
排除标准
- •Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)
- •History of other malignancy ≤ 5 years
- •Prior chemotherapy or radiation therapy
- •Concurrent disease precluding protocol treatment
- •Pregnancy, lactation
- •Non-compliance
研究组 & 干预措施
Arm A
4 Cycles of Nivolumab plus AVD followed by IF-RT (30 Gy)
干预措施: Nivolumab (Drug)
Arm A
4 Cycles of Nivolumab plus AVD followed by IF-RT (30 Gy)
干预措施: Adriamycin (Drug)
Arm A
4 Cycles of Nivolumab plus AVD followed by IF-RT (30 Gy)
干预措施: Vinblastine (Drug)
Arm A
4 Cycles of Nivolumab plus AVD followed by IF-RT (30 Gy)
干预措施: Dacarbazine (Drug)
Arm B
4 Cycles of Nivolumab, followed by 2 cycles of Nivolumab plus AVD, followed by 2 Cycles of AVD followed by IF-RT (30 Gy)
干预措施: Nivolumab (Drug)
Arm B
4 Cycles of Nivolumab, followed by 2 cycles of Nivolumab plus AVD, followed by 2 Cycles of AVD followed by IF-RT (30 Gy)
干预措施: Adriamycin (Drug)
Arm B
4 Cycles of Nivolumab, followed by 2 cycles of Nivolumab plus AVD, followed by 2 Cycles of AVD followed by IF-RT (30 Gy)
干预措施: Vinblastine (Drug)
Arm B
4 Cycles of Nivolumab, followed by 2 cycles of Nivolumab plus AVD, followed by 2 Cycles of AVD followed by IF-RT (30 Gy)
干预措施: Dacarbazine (Drug)
结局指标
主要结局
Complete Remission Rate
时间窗: 4 to 6 weeks after end of treatment
次要结局
- Treatment related Morbidity(1 year after end of treatment)
- Progression Free Survival(1 and 3 years after end of treatment)
- Overall Survival(1 and 3 years after end of treatment)
研究者
Dr. Paul Broeckelmann
Dr.
University of Cologne