Efficacy of Chemotherapy or Chemo-anti-PD-1 Combination After Failed Anti-PD-1 Therapy for Relapsed and Refractory Hodgkin Lymphoma: a Series From Lysa Centers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Overall response rate after re-exposure to chemotherapy
研究概览
简要总结
Anti-PD-1 therapy provides high response rates in Hodgkin lymphoma (HL) patients who have relapsed or are refractory (R/R) to autologous stem cell transplantation (ASCT) and brentuximab vedotin (BV), but median progression free survival (PFS) is only one year. The efficacy of treatment following anti-PD-1 is not well known.
In this context, the optimal treatment for patients who failed after anti-PD-1 therapy is an issue. To better assess their outcome, the investigators retrospectively analyzed the characteristics and outcome of patients from 14 LYSA (The Lymphoma Study Association) centers who lost response to anti-PD-1 therapy and received additional CT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Initial diagnosis of classical HL
- •Optional histopathology confirmation of relapse/refractory HL, (2) age ≥ 18 years
- •Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 to 2
- •Patients must be have received: at least 2 prior regimens and have received or be ineligible for autologous stem cell transplant and must have received prior BV, and at least 2 cycles of single agent anti-PD-1 as last treatment before entering the study,
- •Patients must have inadequate response to anti-PD-1 monotherapy (progressive disease or partial response according to Lugano criteria) with at least one hypermetabolic lesion over the liver and mediastinum background at time of inclusion in the study
- •Previous allogeneic stem cell transplant was allowed. Patients treated with radiotherapy alone after anti-PD1 or combined with anti-PD1 treatment were not included in the study.
排除标准
- •radiotherapy in the treatment after anti-PD1
结局指标
主要结局
Overall response rate after re-exposure to chemotherapy
时间窗: 10 weeks
Patient evaluation was timed by treating physicians according to the policy of each center, and all patients were evaluated after a median of 10 weeks (min 7 weeks, max 12 weeks) with PET/CT using Lugano criteria
次要结局
- Outcomes including PFS(up to 12 months)
- The toxicities experienced during CT or anti-PD-1 plus CT combination(10 weeks)
- Outcomes including overall survival (OS).(up to 24 months)
- Best response obtained (Group 1)(10 weeks)
- Best response obtained (Group 2)(10 weeks)