None listed
Conditions
Brief summary
People with haematological malignancies are at increased risk of severe disease and death from COVID-19. New vaccines from Pfizer and AstraZeneca are reporting high immunogenicity and efficacy in clinical trials, but there is lack of data regarding how well people with haematological cancers respond to vaccines, to what extent and how durable responses may be. It seems reasonable that responses will differ in patients with haematological malignancy, based on both disease factors and factors related to specific anti-cancer treatments. Follicular lymphoma (FL) and Waldenstrom Macroglobulinaemia (WM) are two low grade non-Hodgkin lymphomas that offer potential models to study the impact of immunocompromisation on the immunogenicity of the COVID-19 vaccines. This study, combined with our evolving understanding of which types of vaccine responses are most important in conferring long-term protection against COVID-19, will allow people with FL and WM to make better informed decisions about treatment induction and maintenance options when indicated. It will also provide patients who have already completed treatment a better idea of how much protection to expect and what additional precautions might be required (e.g. preventative pharmacological agents in development, ongoing isolation if necessary, or additional vaccination if evidence emerges to support that).
Interventions
Patients with haematological malignancies such as Follicular Lymphoma (FL) and Waldenstrom's Macroglobulinaemia (WM) may have reduced response to the COVID-19 vaccine. This is due to changes in the immune system, either due to the disease itself and their disease treatments (such as chemotherapy). This study aims to assess the immune responses of patients with FL and WM to the COVID-19 vaccine. This study does this by collecting blood samples at defined timepoints:
T1 Baseline (Day of 1st vaccin
Patients with haematological malignancies such as Follicular Lymphoma (FL) and Waldenstrom's Macroglobulinaemia (WM) may have reduced response to the COVID-19 vaccine. This is due to changes in the immune system, either due to the disease itself and their disease treatments (such as chemotherapy). This study aims to assess the immune responses of patients with FL and WM to the COVID-19 vaccine. This study does this by collecting blood samples at defined timepoints: T1 Baseline (Day of 1st vaccine dose or up to 2 weeks prior). T2 Post 1st vaccine dose (Day of 2nd dose, or any day a minimum of 21 days post 1st dose). T3 Post 2nd vaccine dose (28 days +/- 14 days post 2nd dose) T4 6 months (180 days +/- 30 days post 2nd dose) T5 12 months following 2nd vaccination (+/- 30 days): this time point is not yet confirmed and will depend on data analysed following T4 and appropriateness for collection.
Sponsors
Concord Repatriation General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patient with low grade FL treated with immunochemotherapy 2. Patients with FL who are treatment-naïve. 3. Patients with WM currently on treatment with a BTKi 4. Patients with WM during or following treatment with standard immunochemotherapy 5. Patients with WM who are treatment-naïve. 6. A group of healthy volunteers who are controls
Exclusion criteria
1. Patients with additional medical co-morbidities and/or medications that compromise their immune function (e.g. inflammatory bowel disease, rheumatoid arthritis, SLE, HIV, high dose prednisolone for reasons other than lymphoma treatment). If there is any doubt, the final decision will rest with the PI. 2. Those not wishing to consent
Outcome results
None listed