Clinical trial NCT04898985: The Leukemia and Lymphoma Society (LLS) T-cells in Blood Cancer and COVID-19
Official title: The Leukemia and Lymphoma Society (LLS) T-cells in Blood Cancer and COVID-19
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Covid-19
Lead sponsor: Lymphoma and Leukemia Society
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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).

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 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.

Eligibility criteria: Inclusion Criteria:

* Select patients participating in the LLS COVID-19 Registry will be invited to enroll

Exclusion Criteria:

* People who have not participated in the LLS COVID-19 Registry

Primary outcomes:
measure: Number of people who have developed T cells from a COVID-19 vaccination
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rye Brook
country: United States
facility: Lymphoma and Leukemia Society
state: New York
Study officials:
References: