A Prospective Cohort Study to Define Infectious Burden, the Seroprevalence of Vaccine Preventable Pathogens and Immune Recovery in the First Year Following Completion of Therapy in Patients With Acute Lymphoblastic Leukemia (ALL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 12
- 主要终点
- Incident infection rate in subjects one year post acute lymphoblastic leukemia therapy compared to the incident infection rate in healthy controls
研究概览
简要总结
This observational study aims to assess recovery of the immune system and immunity to vaccine-preventable diseases in children, adolescents, and young adults who recently completed treatment for acute lymphoblastic leukemia (ALL). Several children's hospitals in the United States are participating in the study, which will enroll up to 100 pediatric participants. The study is intended to determine the rate of infection after leukemia treatment and to inform future studies and recommendations about whether children and adolescents who have leukemia should receive additional vaccine doses or boosters after treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 31 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children, adolescents, and young adults diagnosed with B or T ALL at age 12 months or older
- •Completed ALL chemotherapy within the past three months or will complete ALL chemotherapy in the upcoming three months
- •Three years of age or older at time of enrollment
排除标准
- •Diagnosis of infant ALL
- •Evidence of disease relapse
- •History of primary immunodeficiency (except related to Down Syndrome)
- •History of a stem cell transplant or cellular immunotherapy
- •History of prior malignancy or condition requiring chemotherapy other than for current ALL diagnosis
研究组 & 干预措施
Children, adolescents, and young adults who recently completed ALL treatment
This cohort of participants who recently completed leukemia therapy will be assessed for infection incidence during the year following treatment and give blood samples to be measured for antibodies to vaccine-preventable diseases. A small subset will also have their blood samples tested for B and T cell recovery.
干预措施: Observational only: Serology and flow cytometry for ALL cohort participants (Other)
Children, adolescents, and young adults who recently completed ALL treatment
This cohort of participants who recently completed leukemia therapy will be assessed for infection incidence during the year following treatment and give blood samples to be measured for antibodies to vaccine-preventable diseases. A small subset will also have their blood samples tested for B and T cell recovery.
干预措施: Observational only: Infection rates (Other)
结局指标
主要结局
Incident infection rate in subjects one year post acute lymphoblastic leukemia therapy compared to the incident infection rate in healthy controls
时间窗: 1 year
Infections will include clinical and/or microbiologically confirmed infections. All unique infections for a given subject will be captured and included in the final infection rate per person time estimate. The total number of unique infections identified within the first year after completing chemotherapy will be reported as a rate per 1000 follow-up days. All infection rates will be reported as a post estimate with 95 percent confidence intervals. Patients will be censored at time of loss to follow-up, relapse, or death.
Incident Infection Rate in Participants During the First Year Post-acute Lymphoblastic Leukemia Therapy
时间窗: 1 year
Infections include clinical and/or microbiologically confirmed infections as well as patient-reported infections during follow-up. All unique infections for a given subject will be captured and included in the final infection rate per person time estimate. The total number of unique infections identified within the first year after completing chemotherapy will be reported as a rate per patient-year. Patients will be censored at time of loss to follow-up, relapse, or death.
次要结局
- Proportion of patients with seroprevalence of measles antibodies at each study timepoint(1 year)
- Proportion of patients with seroprevalence of varicella antibodies at each study timepoint(1 year)
- Proportion of patients with seroprevalence of pneumococcus antibodies at each study timepoint(1 year)
- Proportion of Patients With Seroprevalence of Measles Antibodies at Each Study Timepoint(1 year)
- Proportion of Patients With Seroprevalence of Varicella Antibodies at Each Study Timepoint(1 year)
- Proportion of Patients With Seroprevalence of Pneumococcus Antibodies at Each Study Timepoint(1 year)