Session: 905. Outcomes Research—Lymphoid Malignancies: Poster II
Hematology Disease Topics & Pathways:
Research, clinical trials, Clinical Research, patient-reported outcomes, real-world evidence, registries
Given the complexity of blood cancer underlying biology and management options, as well as knowledge and access gaps that impede highest quality treatment for certain populations, real-world evidence is emerging as a key tactic to identify and address these issues.
Here, we describe The Leukemia & Lymphoma Society (LLS) National Registry (LLS-Registry), a novel platform that coordinates large-scale patient advocacy-based recruitment and research objectives with high quality data collection and insights generation to compile a broad collaborative data set of diseases, treatments, and outcomes driving rapid, meaningful impact for patients.
In February 2021, the LLS-Registry was launched with a surge of 1,000+ participants joining in the first two weeks, followed by a steady 500-1000 patients each month thereafter, demonstrating robust patient engagement (NCT04806295, NCT04794387). Upon joining the LLS-Registry, participants also onboarded with Ciitizen, a novel, patient-centric platform that leverages HIPAA right-of-access to collect medical records, and then uses a combined Machine Learning (ML) and human review process to organize the data into a standardized, research-ready format. A subset of participants also submitted blood samples to assess their response to SARS-CoV-2 vaccination, as described in NCT04898985.
Participant Characterization: As of July 2022, 12,000+ participants have now consented into the LLS-Registry, with 9,000+ providing survey data, 6,000+ with linked survey data and comprehensive medical records collected, and 3,000+ who provided serial blood samples for the SARS-CoV-2 vaccination response study. The participants include all US states and all major blood cancer types. Zip code analysis shows that 58.2% (2,601) of participants live in urban areas and 41.8% (1,866) in rural areas. They are 57.8% female (5,208) and 42.0% male (3,784), with a median age of 66 (Table 1).
Characterizing SARS-CoV-2 Vaccination Immune Response: As vaccines became available, a key question for patients with hematologic malignancies was whether they would be effective, given potential immunosuppression due to disease or treatment. To investigate this, participants were invited to provide repeated blood samples to examine the B- and T-cell mediated response to the mRNA vaccines. Initial findings on the anti-spike antibody response guided real-time decision-making about vaccination and booster strategy for this at-risk population (Greenberger et al., Cancer Cell 2021; 39: 1031-1033 and 1295-1297). In newly reported data, we observe 58% (166/284) of seropositive and 45% (99/221) of seronegative patients displayed a positive T-cell response after the second vaccination, suggesting partial immune protection in this population, as well as seroconversion associated with functionally meaningful levels of anti-spike antibodies in approximately 20% of patients after the third vaccination. We are also monitoring breakthrough COVID-19 infections that have occurred in 9% (295/3293) of patients, predominantly during the Omicron variant surge, to understand how various factors impact vaccine efficacy.
CONCLUSIONS & FUTURE DIRECTIONS
By linking a highly-engaged patient population with robust data collection and analytics via the LLS-Registry, we have demonstrated the utility of this data collective to generate timely and meaningful insights for SARS-CoV-2 vaccination immune efficacy in this vulnerable population. We are now expanding the depth of data by extracting and analyzing additional medical records, which will allow us to more carefully correlate and compare vaccine response with documented treatments (e.g., BTK inhibitors and anti-CD20 antibodies) (Figure 1).
We will continue to address timely and impactful research questions using the breadth and depth of data within this dataset, for example exploring optimal sequencing of treatment regimens, real-world side effects and tolerability, long-term outcomes, and ultimately identifying and quantifying diversions from the standard of care based on geography and social determinants of health.
Disclosures: Cornew: Invitae: Current Employment. Cardillo: Invitae: Current Employment. Fields: Adapative Bioscience: Ended employment in the past 24 months. Littleford: Invitae: Current Employment. Martin: Invitae: Current Employment. Nottke: Invitae: Current Employment. O'Brien: Invitae: Current Employment. Rosenbaum: Invitae: Current Employment. Sanders: Adapative Bioscience: Current Employment.
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