Safety and Efficacy Evaluation of Low-dose Nivolumab in Combination With AVD as Frontline Therapy for Classic Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- To determine general response
研究概览
简要总结
This study aims to prove the efficacy and safety of low dose nivolumab (40mg as the lowest available presentation) in combination with AVD (adriamycin,vinblastine sulfate and dacarbazine) as frontline treatment for classic Hodgkin's lymphoma.
详细描述
The main objective of this project is to prove the efficacy and safety of Nivolumab used as an standard dose of 40mg ( as the lowest available presentation) in combination with AVD as frontline therapy for Hodgkin's lymphoma.
Patients classification.
We will categorize patients in three groups as follows:
- Early stages by Ann-arbor classification (I,II) with no risk factors (as stablished by NCCN's guidelines criteria).
- Early stages by Ann.arbor classification (I,II) with risk factors ( as stablished by NCCN's guidelines criteria).
- Advanced stages by Ann-arbor classification (III,IV).
Methodology:
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with recent diagnosis of classic Hodgkin's lymphoma demonstrated by incisional or excisional biopsy of adenopathy.
- •Treatment naive patients.
- •Any stage
- •Any functional status.
排除标准
- •Patients with refractory or relapsed disease.
- •Patients with non classical variety.
- •Patients with chronic or active infections at the moment of recruiting.
- •Patients younger than 16 years old.
- •Pregnancy
研究组 & 干预措施
LowN-AVD
classic Hodgkin's lymphoma patients receiving low dose nivolumab in combination with AVD
干预措施: low dose nivolumab in combination with AVD (Drug)
结局指标
主要结局
To determine general response
时间窗: Six weeks after completion of therapy.
To determine patients achieving either a complete response or a partial response as demonstrated with PET C/T evaluation.
次要结局
- Response duration(up to 2 years)
- Adverse effects(through the study completion and up to 6 months)
研究者
David Gomez Almaguer
Dr.
Hospital Universitario Dr. Jose E. Gonzalez