Retrospective, Multicentric, Observational Study to Evaluate the Efficacy and Safety of the Combination of an Immune Checkpoint Inhibitor (ICI) and Radiotherapy (RT) in Patients With Relapsed/Refractory (R/R) Classical Hodgkin Lymphoma (cHL)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Complete remission (CR) rate measured according to Lugano and Lyric criteria by CT-PET (positron emission tomography / computer tomography) or CT (computer tomography) scan
研究概览
简要总结
This is an observational retrospective study to investigate the efficacy and safety of the treatment with an immune checkpoint inhibitor (nivolumab or pembrolizumab) in combination with radiotherapy in patients with relapsed/refractory classical Hodgkin lymphoma.
详细描述
In patients with relapsed/refractory Hodgkin lymphoma, treatment with immune checkpoint inhibitors (ICIs), nivolumab and pembrolizumab, leads to 20-30% of complete remission (CR) rate. This means that for the majority of patients a consolidation strategy is usually offered, in order to reduce relapse rate.
Strategies to improve CR rates should therefore be implemented, including combination treatments. In solid tumors, the combination of ICIs and radiotherapy led to higher response rates without mjor toxicity concerns. Radiotherapy is an effective therapeutic option already used in Hodgkin lymphoma patients, also in the setting of relapsed/refractory disease. In his observational study we aim to evaluate the efficacy and safety of ICIs and radiotherapy administered in combination in patients with relapsed/refractory Hodgkin lymphoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years
- •diagnosis of classical Hodgkin lymphoma, treated with one immune checkpoint inhibitor (ICI) (nivolumab or pembrolizumab), as per label indication
- •having received a concomitant radiotherapy, as per clinical need (persistence of localized disease, bulky disease, other reasons). "Concomitant" radiotherapy means a treatment received during the administration of ICI, or during the 8 weeks that precede or follow the start or the end of the treatment with ICI
排除标准
- •Having received a treatment with an ICI and radiotherapy not "concomitant", according to the abovementioned definition
- •Having received any other anti-lymphoma treatments during the same period of time
- •Patients who have not been evaluated by CT-PET or CT at the end of the combination therapy
研究组 & 干预措施
treated patients
patients with relapsed/refractory Hodgkin lymphoma who received a treatment with the combination of radiotherapy and an immune checkpoint inhibitor
干预措施: Immune checkpoint inhibitor (Drug)
结局指标
主要结局
Complete remission (CR) rate measured according to Lugano and Lyric criteria by CT-PET (positron emission tomography / computer tomography) or CT (computer tomography) scan
时间窗: up to 2 months after the end of ICI or 3 months after the end of RT
次要结局
- overall response rate (ORR) measured according to Lugano and Lyric criteria by CT-PET or CT scan(up to 2 months after the end of ICI or 3 months after the end of RT)
- safety profile assessed by monitoring adverse events (AEs) and serious adverse events (SAEs) according to CTCAE v. 4.0(through study completion, for an average of 1 year)
- progression-free survival (PFS) measured according to Cheson 2007 response criteria(from the start of the treatment until the date of documented progression or date of death from any cause, assessed up to 5 years)
研究者
Francesco Zaja
Professor
Ospedale Maggiore Di Trieste