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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04898985
Other study ID # LLSC19-002
Secondary ID
Status Suspended
Phase
First received
Last updated
Start date May 20, 2021
Est. completion date May 20, 2031

Study information

Verified date August 2022
Source Lymphoma and Leukemia Society
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
ImmunoSEQ
experiment assay

Locations

Country Name City State
United States Lymphoma and Leukemia Society Rye Brook New York

Sponsors (1)

Lead Sponsor Collaborator
Larry Saltzman, MD

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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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