Idiotypic Vaccination for Poor-prognosis Follicular Lymphoma Patients in First Relapse
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Percentage of patients who both never relapse and have a second complete response longer than their first response (cured)
研究概览
简要总结
Poor prognosis follicular lymphoma patients have an estimated median overall survival of 5-6 years. The proposed trial offers life-time idiotypic vaccination to all such patients in first relapse/progression who will achieve second (first, in the case of patients who have never achieved complete response following standard first-line treatment) complete response through autologous stem cell transplant prior to vaccination start. The ultimate goal is a cure, defined as a vaccine-maintained complete response lasting both at least 10 years and at least twice as long as each patient's first complete response.
详细描述
Idiotypic vaccination has already proved capable (in responding patients) of: biological efficacy, that is the capacity of inducing an idiotype- and tumor-specific immune response (Kwak LW et al. NEJM 1992); clinical efficacy, that is the capacity of inducing specific immune responses able to kill in vivo follicular lymphoma cells that had survived pre-vaccine chemotherapy (Bendandi M et al. Nature Med 1999): clinical benefit, that is the capacity of prolonging survival of responding patients (Inoges et al. JNCI 2006). Now, we want to test whether it is also capable of contributing to the ultimate goal of preventing relapse indefinitely in responding patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least one of the following:
- •FLIPI score 3 thru 5 at diagnosis and/or at relapse
- •First complete response shorter than 3 years, if no maintenance (Interferon, Rituximab, etc) treatment was administered, or than 5 years if maintenance treatment was administered
- •No treatment has been able to induce complete response until autologous stem cell transplant
- •Poor-prognosis genomic profiling
排除标准
- •any of the following:
- •Unavailability of a harvestable lymph node of at least cm 2x2x2
- •Life expectancy < 1 year
- •Abnormal heart or liver or kidney function
- •ECOG Performance Status > 2
- •Failure to sign informed consent before enrollment
研究组 & 干预措施
A
All patients will receive the same vaccination schedule/formulation
干预措施: Follicular lymphoma, patient-specific, soluble protein idiotype vaccine (Biological)
结局指标
主要结局
Percentage of patients who both never relapse and have a second complete response longer than their first response (cured)
时间窗: 15 years
次要结局
- Percentage of patients who successfully maintain a measurable, specific immune response throughout the active vaccination time frame(15 years)