Rescue With Brentuximab Plus PD-1 Blockade Followed by Autotransplantation and Consolidation With Brentuximab Plus PD-1 Blockade in Patients With Relapsed/Refractory Hodgkin Lymphoma: Exploratory Single-arm Analysis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
The choice of the best second-line therapy in patients with high LH R/R risk, it is a niche of knowledge not covered at the moment, especially the role of Brentuximab (BV) plus PD-1 blockade and auto-HSCT.
What is the progression-free survival and rate of metabolic responses complete in patients with high-risk R/R HL with the treatment strategy: BV+ PD-1 blockade consolidation with Auto-HSCT and maintenance with BV + PD-blockade
1?
详细描述
Patientes with Refractory/relapsed Hodgkin Lymphoma (HL R/R) with multiple failed therapies represent a therapeutic dilemma. The goal of next-line treatment is long-term disease control with manageable adverse reactions. Given the limited therapeutic options for patients with HL R/R, better therapies should be sought, more effective, with better tolerability, less toxicity, with increased overall survival (OS) of the patients, with the aim of improving outcomes in terms of disease-free survival progression (PFS) of the current standard treatment. Since currently only 50% of the patients with high-risk R/R HL treated with the standard regimen achieve healing. The high effectiveness and low toxicity of immunotherapy with prolonged remission or stabilization of the disease make it a new treatment option promising for HL R/R. Based on the above, a treatment strategy is proposed to rescue base with Brentuximab plus PD-1 blockade followed by autotransplantation and consolidation with Brentuximab plus PD-1 blockade in patients with Hodgkin lymphoma High-Risk Relapse/Refractory Compared to Reported OS and PFS Rates in the literature obtained with standard treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Relapsed/refractory Hodgkin lymphoma to ABVD with definition of high risk.
- •Age ≥ 18 years and ≤ 90 years.
- •Adequate liver function, defined as:
- •Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
- •Serum aspartate aminotransferase (AST) ≤ 3.0 x ULN
- •Serum alanine aminotransferase (ALT) ≤ 3.0 x ULN
- •Adequate renal functions, defined as:
- •Serum creatinine ≤ 1.5x ULN or glomerular filtration rate > 50ml/min.
- •ECOG performance status ≤ 3
- •Women of reproductive potential should have a serum pregnancy test or negative urine.
- •Prior signature of the informed consent.
排除标准
- •Voluntary withdrawal from the study.
- •Develop grade 3 or 4 toxicity according to the INH scale.
- •Loss of follow-up
研究组 & 干预措施
Brentuximab plus PD-1 blocked plus ASCT plus maintenance Brentuximab plus PD-1
Brentuximab plus PD-1 blocked x 8 cycles plus ASCT plus maintenance Brentuximab plus PD-1 x 8 cycles
干预措施: Brentuximab Vedotin 50 MG [Adcetris] (Drug)
结局指标
主要结局
Progression free survival
时间窗: 24 months
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.
次要结局
- overall survival(24 months)
- complete remission(24 months)
研究者
Lauro Fabian Amador Medina
Principal Investigator
Hospital Regional de Alta Especialidad del Bajio