NCT04373083撤回2 期
Anti-PD-1 Antibody Treatment With Cemiplimab and Radiotherapy in Early-stage Favorable Classical Hodgkin Lymphoma (CARHL) - A Randomized Phase II Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Progression-free survival (PFS) at 1 year
研究概览
简要总结
The primary objective is to estimate the efficacy of experimental treatment with the anti-PD-1 antibody cemiplimab (REGN2810) in combination with simultaneous or subsequent radiotherapy (RT) in early-stage favorable classical Hodgkin lymphoma (cHL).
Secondary objectives are to assess the safety and feasibility of the 2 experimental strategies.
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 75 Years（Adult, Older 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
- •Stage I-II without risk factors as defined in the protocol
排除标准
- •Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL)
- •Prior malignancy within the previous 5 years (except for locally treatable cancers that have been apparently cured by complete resection)
- •Prior chemotherapy or radiation therapy
- •Concurrent disease precluding protocol treatment as defined in the protocol
- •Pregnancy or breast-feeding
- •Non-compliance as defined in the protocol
- •Note: Other protocol-defined Inclusion/Exclusion criteria apply
研究组 & 干预措施
Concomitant treatment
Experimental
Treatment Group A
干预措施: Cemiplimab (Drug)
Concomitant treatment
Experimental
Treatment Group A
干预措施: Involved-site radiotherapy (IS-RT) (Radiation)
Sequential treatment
Experimental
Treatment Group B
干预措施: Cemiplimab (Drug)
Sequential treatment
Experimental
Treatment Group B
干预措施: Involved-site radiotherapy (IS-RT) (Radiation)
结局指标
主要结局
Progression-free survival (PFS) at 1 year
时间窗: From randomization up to 1 year
次要结局
- Overall survival (OS) at 1, 2, and 3 years(From randomization up to 3 years)
- Rate of patients with long-term fatigue using EORTC-QLQ-FA12(12-18 months after randomization)
- Types of lymphoma treatment administered in addition to study treatment(From randomization up to 3 years)
- PFS at 2 and 3 years(From randomization up to 3 years)
- Quality of life (QoL) using EORTC-QLQ-30(Up to 3 years)
- Rate of early discontinuation of study treatment(From first dose to up to 19 weeks)
- Incidence of acute toxicities(Up to 90 days after study treatment)
- Frequency of lymphoma treatment administered in addition to study treatment(From randomization up to 3 years)
- Rate of patients with long-term fatigue using EORTC-QLQ-C30(12-18 months after randomization)
研究者
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