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:
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.
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.
