Immune Responses to COVID-19 Vaccination in Lymphoma Patients

NCT ID: NCT04858568

Last Updated: 2024-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

592 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-11

Study Completion Date

2024-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hodgkin lymphoma

Diagnoses:

Hodgkin lymphoma (classical Hodgkin lymphoma)

No interventions assigned to this group

Aggressive B-NHL

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)

No interventions assigned to this group

Indolent B-NHL

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)

No interventions assigned to this group

Peripheral T/NK-cell

Diagnoses:

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bedfordshire Hospitals NHS Foundation Trust

Bedford, Bedfordshire, United Kingdom

Site Status

Portsmouth Hospitals University NHS Trust

Portsmouth, Hampshire, United Kingdom

Site Status

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, United Kingdom

Site Status

Wye Valley NHS Trust

Hereford, Herefordshire, United Kingdom

Site Status

University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, United Kingdom

Site Status

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, United Kingdom

Site Status

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, United Kingdom

Site Status

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, United Kingdom

Site Status

The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Site Status

Countries

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United Kingdom

References

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Lim SH, Stuart B, Joseph-Pietras D, Johnson M, Campbell N, Kelly A, Jeffrey D, Turaj AH, Rolfvondenbaumen K, Galloway C, Wynn T, Coleman AR, Ward B, Long K, Coleman H, Mundy C, Bates AT, Ayres D, Lown R, Falconer J, Brake O, Batchelor J, Willimott V, Bowzyk Al-Naeeb A, Robinson L, O'Callaghan A, Collins GP, Menne T, Faust SN, Fox CP, Ahearne M, Johnson PWM, Davies AJ, Goldblatt D. Immune responses against SARS-CoV-2 variants after two and three doses of vaccine in B-cell malignancies: UK PROSECO study. Nat Cancer. 2022 May;3(5):552-564. doi: 10.1038/s43018-022-00364-3. Epub 2022 Mar 24.

Reference Type DERIVED
PMID: 35332334 (View on PubMed)

Other Identifiers

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RHM CAN1612

Identifier Type: -

Identifier Source: org_study_id

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