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Recruitment was completed for initial evaluation of T-cell response to early Covid-19
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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).
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:
After providing electronic signature to the informed consent, this Research Study requires patients who have received an FDA authorized vaccination, and depending on the type of cancer, have developed no antibodies or limited antibodies, to provide one blood sample of less than 3ccs drawn at any LabCorp facility (at no cost to patients). LabCorp facility locations can be found online at https://www.labcorp.com/labs-and-appointments-advanced-search.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ImmunoSEQ | Diagnostic Test | experiment assay |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lymphoma and Leukemia Society | Rye Brook | New York | 10573 | United States |
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.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |