Immune Responses to COVID-19 Vaccination in Lymphoma Patients (PROSECO)

University Hospital Southampton NHS Foundation Trust

Status: Completed

Conditions: Marginal Zone Lymphoma; Small Lymphocytic Lymphoma; Mantle Cell Lymphoma; High-grade B-cell Lymphoma; Primary Mediastinal B Cell Lymphoma; Lymphoplasmacytic Lymphoma; Classical Hodgkin Lymphoma; Nodular Lymphocyte Predominant Hodgkin Lymphoma; Follicular Lymphoma; Chronic Lymphocytic Leukemia; Burkitt Lymphoma; Diffuse Large B Cell Lymphoma; Peripheral T-cell Lymphoma

Study type: Observational

Funder types: Other

Identifiers

NCT04858568

RHM CAN1612

Details and patient eligibility

About

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.

Enrollment: 592 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

592 participants in 4 patient groups

Hodgkin lymphoma

Description:

Diagnoses: Hodgkin lymphoma (classical Hodgkin lymphoma)

Aggressive B-NHL

Description:

Diagnoses: Aggressive B-NHL (E.g. Diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, high-grade B-cell lymphoma, Burkitt lymphoma, de novo transformed lymphoma, follicular lymphoma grade 3b)

Indolent B-NHL

Description:

Diagnoses: Indolent B-NHL (E.g.follicular lymphoma grades 1-3a, mantle cell lymphoma, marginal zone lymphoma, chronic lymphocytic leukaemia/small lymphocytic lymphoma, lymphoplasmacytic lymphoma, nodular lymphocyte predominant Hodgkin lymphoma)

Peripheral T/NK-cell

Description:

Diagnoses: Peripheral T/NK-cell lymphomas (any mature T/NK cell malignancy)