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临床试验/NCT04898985
NCT04898985暂停不适用

The Leukemia and Lymphoma Society (LLS) T-cells in Blood Cancer and COVID-19

Larry Saltzman, MD1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2021年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
1,000
试验地点
1
主要终点
Number of people who have developed T cells from a COVID-19 vaccination

研究概览

简要总结

Five hundred (500) patients participating in the LLS COVID-19 Registry, who have shown either no antibody or limited antibody response by way of the Spike Antibody test to one of the vaccinations authorized for emergency use (EUA) by FDA will participate in the LLS T-cells, Blood Cancer and COVID-19 Clinical Research Study. They will be followed for at least ten years (in the COVID-19 Registry). In addition, 500 patients with similar blood cancer diagnosis, also participating in the LLS COVID-19 Registry, who have shown full Spike antibody response to one of the vaccinations authorized for emergency use (EUA) by FDA will also be enrolled the LLS T-cells, Blood Cancer and COVID-19 Clinical Research Study for comparison (as a control arm) and will also be followed for at least 10 years (in the COVID-19 Registry).

详细描述

LLS has partnered with Adaptive Biotechnologies, to provide their ImmunoSEQ research assay to accumulate data about patients with blood cancer, who have received an FDA authorized vaccination, and depending on the type of cancer, have developed no antibodies or limited antibodies, to determine if these individuals have developed T-cells. While antibodies have been a mainstay in measuring the immune response to vaccines, for COVID-19, it has become clear that the T-cell response is necessary for a complete picture of immunity.

Five hundred (500) patients participating in the LLS COVID-19 Registry, who have shown either no antibody or limited antibody response by way of the Spike Antibody test to one of the vaccinations authorized for emergency use (EUA) by FDA will participate in this Research Study. They will be followed for at least ten years (in the COVID-19 Registry). In addition, 500 patients with similar blood cancer diagnosis, also participating in the LLS COVID-19 Registry, who have shown full Spike antibody response to one of the vaccinations authorized for emergency use (EUA) by FDA will also be enrolled in this Research Study for comparison (as a control arm) and will also be followed for at least 10 years (in the COVID-19 Registry).

Patients will be advised that ImmunoSEQ is not an FDA authorized/approved diagnostic assay and that as a "research assay" results cannot be shared with them.

The process for patients to participate in the LLS T-cells, Blood Cancer and COVID-19 Clinical Research Study includes:

  • LLS will identify who is eligible and who will be invited to participate in this study.
  • Ciitizen will send an email to eligible patients to invite them to participate.
  • Patients will be sent a study page Password and instructed not to share it.
  • Eligible patients will visit the LLS T-cells, Blood Cancer and COVID-19 Clinical Research Study-specific page. Patients will be advised to read the entire Consent Form and, if satisfied, patients will be asked to enter the password and then sign the pop-up consent by entering Name, Email, and Phone Number.
  • Within 24 hours, patients will receive an email notifying them that their unique lab slip has been uploaded into their Ciitizen account. To access, patients will login to their Ciitzen account with their User ID/Password credentials for the LLS T-cells, Blood Cancer and COVID-19 Clinical Research Study.
  • Patients will schedule a blood draw at a LabCorp facility.
  • Note: Patients will be informed that Study results CAN NOT be shared with patients individually; only in aggregate once the Study concludes.
  • And, at any time, should patients have any questions, LLS contact information is on the front page of the Informed Consent document.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Select patients participating in the LLS COVID-19 Registry will be invited to enroll

排除标准

  • People who have not participated in the LLS COVID-19 Registry

结局指标

主要结局

Number of people who have developed T cells from a COVID-19 vaccination

时间窗: 2 years

ImmunoSEQ research assay to accumulate data about patients with blood cancer, who have received an FDA authorized vaccination, and depending on the type of cancer, have developed no antibodies or limited antibodies, to determine if these individuals have developed T-cells.

次要结局

未报告次要终点

研究者

发起方
Larry Saltzman, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Larry Saltzman, MD

Principal Investigator

Lymphoma and Leukemia Society

研究点 (1)

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