Vaccine Responses in Patient With Multiple Myeloma and Non-Hodgkins Lymphoma Post CAR-T Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Preserved immunity
研究概览
简要总结
This study evaluates immune responses after CAR-T therapy to find out if CAR-T therapy reduces the effectiveness of the vaccines (vaccine immunity) against diseases such as measles, mumps and rubella, among others in patients with multiple myeloma and non-Hodgkin lymphoma.
详细描述
PRIMARY OBJECTIVES:
I. To assess positive VPD antibody (Ab) titers prior to and at 6 months after CAR-T therapy to evaluate the impact of CAR-T on immune responses in patients undergoing CAR-T therapy.
II. To assess the change in Ab titer to S. pneumoniae and tetanus at 6 months and 1 year post-vaccination and evaluate if titer increases are correlated to post-vaccination CD4+ count and IgG level.
OUTLINE: This is an observational study.
Patients may receive up to 3 doses of pneumococcal and/or tetanus vaccine per institutional policy of revaccination. Patients undergo blood sample collection and have medical records reviewed throughout the study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* Willingness to provide written informed consent before any study-specific procedures or activities are performed
- •Age ≥ 18 years of age, at the time of consent
- •Documented, histologically or cytologically confirmed diagnosis of multiple myeloma (MM), diffuse large B cell lymphoma (DLBCL),follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL), or primary mediastinal B cell lymphoma (PMBL). All number of prior lines of therapy are allowed
- •History of prior vaccination against common VPD
- •Approved by managing physician for CAR-T therapy, with preparative conditioning planned within the next 90 days
- •Approved by managing physician for revaccination against Streptococcus pneumoniae or tetanus
排除标准
- •* Ongoing use of immunosuppressive agents or plans for immunosuppressive therapy that would interfere with interpretation of study endpoints
- •Uncontrolled, intercurrent illness including, but not limited to, systemic infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements or make the study procedures unadvisable
结局指标
主要结局
Preserved immunity
时间窗: Up to 12 months after CAR-T cell infusion
Will be defined as titers that meet the definition of positive both pre- and post-CAR-T cell infusion. The proportion of subjects who have preserved immunity to each VPD will be estimated with an exact 95% confidence interval.
次要结局
- Change in antibody titers(At baseline, at 6 months and at 1 year after vaccination)
研究者
Amrita Desai, M.D.
Principal Investigator
OHSU Knight Cancer Institute