The Use of 20% Subcutaneous Immunoglobulin Replacement Therapy in Patients With B Cell Non Hodgkin's Lymphoma With Humoral Immune Dysfunction After Treatment With Rituximab
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of non-neutropenic infections per subject requiring antibiotics in the year after enrollment
研究概览
简要总结
To study the use of subcutaneous (injected under the skin) immunoglobulin replacement therapy (replacement of antibodies, which are infection-fighting proteins) in patients with a type of blood cancer called lymphoma, who have been treated with rituximab (a type of chemotherapy) and have an abnormal immune system putting them at increased risk of infection.
详细描述
The investigators propose evaluating patients with B cell non-Hodgkin's lymphoma treated with rituximab within the past 2 years with baseline immunoglobulin levels and vaccine responses to polysaccharide (pneumococcus, meningococcus) and peptide (tetanus, diphtheria) antigens. Patients with impaired vaccine responses may benefit most from immunoglobulin prophylaxis and will be proactively started on 20% subcutaneous replacement therapy. This study is novel in that it will stratify patients according to their humoral response to polysaccharide and peptide vaccines, and will proactively initiate therapy with the new 20% subcutaneous immunoglobulin in those with impaired humoral response rather than starting it after infections occur. This will potentially lead to decreased infections and improved quality of life.
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
- •Diagnosis of B cell non-Hodgkin's lymphoma
- •Medically stable
- •Able to understand and willingness to sign a written informed consent
- •Able to comply with study procedures
排除标准
- •Previously diagnosed primary immunodeficiency
- •Additional immunosuppressive states
- •Ongoing therapy with Ig replacement
研究组 & 干预措施
Immunoglobulin therapy
Patients with abnormal humoral function following treatment with rituximab will be treated with 20% subcutaneous immunoglobulin.
干预措施: 20% subcutaneous immunoglobulin (Drug)
结局指标
主要结局
Number of non-neutropenic infections per subject requiring antibiotics in the year after enrollment
时间窗: 1 year
How many antibiotics are prescribed in one year for any type of infection
次要结局
- Quality of life score for participants during the one year enrollment(1 year)
研究者
S. Shahzad Mustafa
Physician, Associate Medical Director
Rochester General Hospital