The Leukemia and Lymphoma Society (LLS) T-cells in Blood Cancer and COVID-19 (LLST-Cells)

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).

Study Overview

• Status: Suspended
• Conditions: Covid-19
• Intervention / Treatment: Diagnostic test: ImmunoSEQ

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• United States
  • New York
    • Rye Brook, New York, United States, 10573
      • Lymphoma and Leukemia Society

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: ImmunoSEQ; experiment assay
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).	Diagnostic test: ImmunoSEQ; experiment assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Larry Saltzman, MD

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 20, 2021
• Primary Completion (ANTICIPATED): May 20, 2031
• Study Completion (ANTICIPATED): May 20, 2031

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (ACTUAL): May 24, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 15, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: LLSC19-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No