Chronic Lymphocytic Leukemia Clinical Trial
— PROSECOOfficial title:
PROSECO - A UK Multicentre Prospective Observational Study Evaluating COVID-19 Vaccine Immune Responses in Lymphoid Cancer
| NCT number | NCT04858568 |
| Other study ID # | RHM CAN1612 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 11, 2021 |
| Est. completion date | January 31, 2024 |
| Verified date | February 2024 |
| Source | University Hospital Southampton NHS Foundation Trust |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This prospective observational study aims to evaluate the robustness and persistence of immune responses to vaccination, define factors associated with impaired immune responses and assess the incidence of COVID-19 infections in vaccinated individuals. To do this, we will collect peripheral blood from patients with lymphoid cancers before and after their COVID-19 vaccination. The blood will be explored in the laboratory for antibodies to SARS-CoV-2 and T-cell responses to the spike protein. Detailed clinical information will also be collated on about their cancer and treatment.
| Status | Completed |
| Enrollment | 592 |
| Est. completion date | January 31, 2024 |
| Est. primary completion date | October 31, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | INCLUSION CRITERIA 1. Patients having a confirmed diagnosis of either: A) Hodgkin lymphoma B) Aggressive B-cell lymphoma (e.g. Burkitt's lymphoma, diffuse large B-cell lymphoma, grade 3b follicular lymphoma, de novo transformed follicular lymphoma) C) Indolent B-cell lymphoma (e.g. all grades of follicular lymphoma except grade 3b, marginal zone lymphoma, lymphoplasmacytic lymphoma, chronic or small lymphocytic lymphoma, mantle cell lymphoma) D) Mature T/NK-cell malignancy (any subtype) 2. Patient must be = 18 years. 3. Patients will have provided written Informed Consent. EXCLUSION CRITERIA 1) Serious medical or psychiatric illness likely to affect participation or that may compromise the ability to give informed consent. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Bedfordshire Hospitals NHS Foundation Trust | Bedford | Bedfordshire |
| United Kingdom | Wye Valley NHS Trust | Hereford | Herefordshire |
| United Kingdom | University Hospitals of Leicester NHS Trust | Leicester | Leicestershire |
| United Kingdom | The Newcastle Upon Tyne Hospitals NHS Foundation Trust | Newcastle Upon Tyne | Tyne And Wear |
| United Kingdom | Norfolk and Norwich University Hospitals NHS Foundation Trust | Norwich | Norfolk |
| United Kingdom | Nottingham University Hospitals NHS Trust | Nottingham | Nottinghamshire |
| United Kingdom | Oxford University Hospitals NHS Foundation Trust | Oxford | Oxfordshire |
| United Kingdom | Portsmouth Hospitals University NHS Trust | Portsmouth | Hampshire |
| United Kingdom | University Hospital Southampton NHS Foundation Trust | Southampton | Hampshire |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Southampton NHS Foundation Trust |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Serum IgG levels against SARS-CoV-2 post-COVID-19 vaccination and change over time. | To evaluate the robustness and persistence of anti-S IgG levels. | 12 months | |
| Secondary | Comparison between SARS-CoV-2 IgG responses with clinical parameters. | Correlation between anti-S IgG between different lymphoma subtypes and the impact of treatment. | 12 months | |
| Secondary | Symptomatic COVID-19 with positive SARS-CoV-2 PCR results. | To assess the incidence of symptomatic, virologically proven COVID-19 in vaccinated individuals within 12 months of vaccine administration. | 12 months |
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|---|---|---|---|
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