Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04898985
Status:
SUSPENDED
Last Update Posted:
2022-08-17
First Post:
2021-05-20
Brief Title:
The Leukemia and Lymphoma Society LLS T-cells in Blood Cancer and COVID-19
Sponsor:
Larry Saltzman MD
Organization:
Lymphoma and Leukemia Society
Study Overview
Official Title:
The Leukemia and Lymphoma Society LLS T-cells in Blood Cancer and COVID-19
Status:
SUSPENDED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment was completed for initial evaluation of T-cell response to early Covid-19
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LLST-Cells
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
Detailed Description:
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 authorizedapproved 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 IDPassword 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
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 httpswwwlabcorpcomlabs-and-appointments-advanced-search
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 authorizedapproved 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 IDPassword 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
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 httpswwwlabcorpcomlabs-and-appointments-advanced-search
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None