NCT04794387

The Lymphoma and Leukemia Society Amended COVID-19 Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (actual)
• Sponsor: Blood Cancer United · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: —

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.

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.

Conditions

• Covid19

Interventions

Type	Name	Description
BIOLOGICAL	Amended LLS COVID-19 Registry	Do people with blood cancer who did not develop antibodies after a complete COVID-19 vaccination, develop antoibodies after a COVID-19 booster?

Timeline

• Start date: 2021-08-27
• Primary completion: 2022-12-13
• Completion: 2022-12-13
• First posted: 2021-03-12
• Last updated: 2023-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study