Switched Memory B-cells as a Marker for Humoral Immune System Recovery in Patients With Secondary Antibody Deficiency Due to Hematological Malignancies
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- IGRT discontinuation rate
研究概览
简要总结
Current treatment for patients with secondary antibody deficiency (SAD) is Immunoglobulin replacement therapy (IGRT). There are currently no clinical guidelines for IGRT discontinuation in patients with SAD. This study will examine the IGRT discontinuation success rate and IGRT discontinuation rate in patients.
详细描述
Immunoglobulin replacement therapy (IGRT) is a mainstay treatment for SAD and has been shown to reduce the risk of infection and increase quality of life in patients with SAD. Current guidelines recommend that patients with severe hypogammaglobulinemia (IgG <4 g/L) or patients with a history of recurrent or severe infections should be offered IGRT, which can be administered intravenously on a monthly basis or more frequently by subcutaneous infusions. There are currently no clinical guidelines for IGRT discontinuation. Although research conducted at the Ottawa Hospital indicates successful discontinuation of IGRT, clinicians need a tool to predict the recovery of humoral immunity and the risk of infection in these patients in order to determine whether IGRT may be safely discontinued.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •History of leukemia, lymphoma, or plasma cell disease
- •Receiving IGRT for SAD for at least 12 months
- •Over 18 years of age
- •Able to provide informed consent
- •Able to speak English or French
- •Available for ongoing follow-up as required
排除标准
- •Receiving chemotherapy or immune-oncology treatment during the study period
- •Severe infection within the last 6 months
研究组 & 干预措施
IGRT discontinuation
Participants will be tested to determine Switched memory B cells (SMB) levels. If SMB cells are ≥ 2%, IGRT will be discontinued. If SMB cells are < 2%, the patient will remain on IGRT and a maximum of 40 mL of blood will be drawn again in 3-6 months to reassess SMB levels and eligibility for IGRT discontinuation.
干预措施: Immunoglobulin replacement therapy (IGRT) (Drug)
结局指标
主要结局
IGRT discontinuation rate
时间窗: 12 months post discontinuation
IGRT discontinuation rate defined as the proportion of recruited adult patients with SAD who discontinue IGRT during the study period.
IGRT discontinuation sucess rate
时间窗: 12 months post discontinuation
IGRT discontinuation success rate defined as the proportion of patients with normal SMB levels who stop IGRT and experience less than or equal to 1 moderate infection and no severe infection within 12 months of IGRT discontinuation. Moderate infection will be defined as an infection that requires outpatient oral antimicrobial treatment. Severe infection will be defined as an infection that requires intravenous antimicrobial treatment and/or hospitalization.
次要结局
- Cost saving potential(Through study completion, an average of 1 year)
- Change in Health-Related Quality of Life(Through study completion, an average of 1 year)
- Receiver operating curve (ROC)(Through study completion, an average of 1 year)