PD-L1 and PD-L2 Peptide Vaccination as Consolidation for Relapsed Follicular Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Adverse events evaluated by CTCAE 4.03
研究概览
简要总结
An open phase-1, first-in-human, clinical trial investigating the safety and immunological effects of peptide vaccination with Programmed Death Ligand 1 and 2 (PD-L1 and PD-L2) peptides in patients with relapsed follicular lymphoma.
详细描述
Follicular lymphoma (FL) is the the most common of the indolent lymphomas, with an incidence in Denmark of 220 per year. In 90% of the cases the disease is incurable why the treatment strategy often is watchful waiting until significant signs of progression or transformation. After chemotherapy, maintenance therapy is often used to increase disease control.
The microenvironment and immune escape mechanism are believed to play a major role in the persistence of the lymphoma. One escape mechanism is the PD-L1 and PD-L2 molecules expressed in the microenvironment of follicular lymphoma inhibiting the T-cells. By stimulating the T-cells to attack PD-L1 and PD-L2 expressing cells we hope to hamper the immunosuppressive tumor environment and establish immune tumor control.
10 patients treated with standard therapy are needed for the trial and each patient will receive 15 vaccinations over the course of one year.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically documented FL grade I-IIIa, with no sign of current transformation. Patients cured of transformed lymphoma are eligible.
- •A minimum of one line of induction therapy. Maintenance rituximab can continue along with the vaccination
- •At least partial response to the latest standard treatment
- •A minimum of 4 weeks since last treatment
- •ECOG performance status of 0 or 1
- •Life expectancy ≥ 12 weeks
- •Adequate hematologic and end-organ function
排除标准
- •Progression with the presence of at least one GELF criteria or transformation at inklusion time.
- •Other active malignant diseases
- •Significant medical condition per investigators judgement e.g. severe Asthma/COLD, poorly regulated heart condition, insulin dependent diabetes mellitus.
- •Acute or chronic viral/bacterial infection e.g. HIV, CMV, EBV, hepatitis or tuberculosis
- •Serious known allergies or earlier anaphylactic reactions.
- •Known sensibility towards Montanide ISA-51
- •Any active autoimmune diseases e.g. autoimmune neutropenia, thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, autoimmune glomerulonephritis, autoimmune adrenal deficiency, autoimmune thyroiditis etc.
- •Pregnancy
结局指标
主要结局
Adverse events evaluated by CTCAE 4.03
时间窗: 1 year follow up
Adverse events are graded 1-5 according to the criteria
次要结局
- Immune responses(1 year)
研究者
Lars Møller Pedersen
Chief consultant
Herlev Hospital