Study Stopped
Recruitment was completed for initial evaluation of T-cell response to early Covid-19
The Leukemia and Lymphoma Society (LLS) T-cells in Blood Cancer and COVID-19
LLST-Cells
1 other identifier
observational
1,000
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2021
CompletedStudy Start
First participant enrolled
May 20, 2021
CompletedFirst Posted
Study publicly available on registry
May 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 20, 2031
August 17, 2022
August 1, 2022
10 years
May 20, 2021
August 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of people who have developed T cells from a COVID-19 vaccination
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.
2 years
Study Arms (2)
500 patients in the LLS COVID-19 Registry with no/limited antibody response
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.
500 patients also participating in the LLS COVID-19 Registry with antibody response
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).
Interventions
experiment assay
Eligibility Criteria
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. 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).
You may qualify if:
- Select patients participating in the LLS COVID-19 Registry will be invited to enroll
You may not qualify if:
- People who have not participated in the LLS COVID-19 Registry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lymphoma and Leukemia Society
Rye Brook, New York, 10573, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 20, 2021
First Posted
May 24, 2021
Study Start
May 20, 2021
Primary Completion (Estimated)
May 20, 2031
Study Completion (Estimated)
May 20, 2031
Last Updated
August 17, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share
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.