The Lymphoma and Leukemia Society Amended COVID-19 Registry

• Sponsor: Lymphoma and Leukemia Society (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04794387
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Anticipated Duration (Months): 113.9
• Patients Per Site Per Month: 8.8

Study Details

Study Description

Brief Summary

The LLS COVID-19 Registry is being amended to invite people who participated in the LLS COVID-19 Registry and did not develop antibodies after receiving a complete COVID-19 vaccination, as well as people with blood cancer who did not participate in the initial LLS COVID-19 Registry and also did not develop antibodies after receiving a complete COVID-19 vaccination, to participate in this amended LLS COVID-19 Registry.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Biological: Amended LLS COVID-19 Registry

Detailed Description

The results of the Leukemia and Lymphoma Society (LLS) COVID-19 Registry indicate that about twenty-five percent (25%) of people with blood cancer and on immunosuppressants participating in the LLS COVID-19 Registry, who received a complete COVID-19 vaccination, did not develop antibodies.

The Food and Drug Administration has authorized third doses (boosters) of the Pfizer and Moderna Covid-19 vaccines for people with weakened immune systems, in a bid to bolster their protection against infection as the highly contagious Delta variant circulates. The agency will amend the emergency-use authorizations for the two vaccines to allow immunocompromised people to get an additional dose.

Therefore the LLS COVID-19 Registry is being amended to invite people who participated in the LLS COVID-19 Registry and did not develop antibodies as noted above, as well as people with blood cancer who did not participate in the initial LLS COVID-19 Registry and also did not develop antibodies after receiving a complete COVID-19 vaccination, to participate in this amended LLS COVID-19 Registry. Using the same design as the initial COVID-19 Registry (Protocol LLSC19-001), this amended LLS COVID-19 Registry will determine if people who have decided to receive a booster vaccination, who did not develop antibodies after receiving a complete COVID-19 vaccination will develop antibodies after a single dose booster of either the Pfizer or Moderna COVID-19 vaccination.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Lymphoma and Leukemia Society Amended COVID-19 Registry
• Actual Study Start Date: Aug 27, 2021
• Anticipated Primary Completion Date: Feb 23, 2031
• Anticipated Study Completion Date: Feb 23, 2031

Outcome Measures

Primary Outcome Measures

1. A SARS antibody test will be paired with surveys to measure the response people with blood cancer, who did not develop antibodes after a complete COVID-19 vaccination, have to the COVID-19 booster. [10 years]

   Observational Study

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• People with blood cancer who did not develop antibodies after a complete COVID-19 vaccination.

Exclusion Criteria:

• People who receiived a complete COVID-19 vaccination and did develop antibodies.

• People unwilling or unable to receive COVID-19 booster.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lymphoma and Leukemia Society	Rye Brook	New York	United States	10573

Sponsors and Collaborators

• Lymphoma and Leukemia Society

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lymphoma and Leukemia Society
• ClinicalTrials.gov Identifier: NCT04794387
• Other Study ID Numbers: LLSC19-001-Amendment 1
• First Posted: Mar 12, 2021
• Last Update Posted: Sep 2, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Lymphoma and Leukemia Society: COVID-19 Booster
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Sep 2, 2021