Covid19NCT04794387
The Lymphoma and Leukemia Society Amended COVID-19 Registry
An observational study of Covid19, run by Blood Cancer United at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Amended LLS COVID-19 Registry
- Type of treatment
- Vaccines
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2021to 13 Dec 2022
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Adult, Older adult
Study population: People with blood cancer who did not develop antibodies after a complete COVID-19 vaccination.
Who may be able to join
- People with blood cancer who did not develop antibodies after a complete COVID-19 vaccination.
Who cannot join
- People who receiived a complete COVID-19 vaccination and did develop antibodies.
- People unwilling or unable to receive COVID-19 booster.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lymphoma and Leukemia Society
Rye Brook, New York, 10573
About this study
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.
Read the 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
- Being tested
- Amended LLS COVID-19 Registry
- Keywords
- COVID-19 Booster
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amended LLS COVID-19 RegistryBiological
Do people with blood cancer who did not develop antibodies after a complete COVID-19 vaccination, develop antoibodies after a COVID-19 booster?
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Observational Study
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start27 Aug 2021
- Primary completion13 Dec 2022
- Study completion13 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Blood Cancer United
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794387
- Sponsor's protocol ID
- LLSC19-001-Amendment 1
- Status last verified
- Aug 2021
- First submitted
- 9 Mar 2021
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: ONLY De-identified data will be made available to researchers approved by The Lymphoma and Leukemia Society.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Lymphoma and Leukemia Society Amended COVID-19 Registry
- ClinicalTrials.gov ID
- NCT04794387
- Acronym / sponsor ID
- LLSC19-001-Amendment 1
- Conditions
- Covid19
- Keywords
- COVID-19 Booster
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Blood Cancer UnitedUniversity, hospital or other
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 13 Dec 2022 (actual)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- People with blood cancer who did not develop antibodies after a complete COVID-19 vaccination.
Key inclusion criteria (1 listed)
- People with blood cancer who did not develop antibodies after a complete COVID-19 vaccination.
Key exclusion criteria (2 listed)
- People who receiived a complete COVID-19 vaccination and did develop antibodies.
- People unwilling or unable to receive COVID-19 booster.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amended LLS COVID-19 RegistryDo people with blood cancer who did not develop antibodies after a complete COVID-19 vaccination, develop antoibodies after a COVID-19 booster? | Biological | – |
Primary outcome
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.
Time frame: 10 years
Observational Study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: Yes. ONLY De-identified data will be made available to researchers approved by The Lymphoma and Leukemia Society.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Blood Cancer United at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.