The Lymphoma and Leukemia Society Amended COVID-19 Registry

Lymphoma and Leukemia Society

Status: Completed

Conditions: Covid19

Treatments: Biological: Amended LLS COVID-19 Registry

Study type: Observational

Funder types: Other

Identifiers

NCT04794387

LLSC19-001-Amendment 1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.