Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04858568
Recruitment Status : Active, not recruiting
First Posted : April 26, 2021
Last Update Posted : October 27, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust

Brief Summary:
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.

Condition or disease
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

Layout table for study information
Study Type : Observational
Actual Enrollment : 592 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: PROSECO - A UK Multicentre Prospective Observational Study Evaluating COVID-19 Vaccine Immune Responses in Lymphoid Cancer
Actual Study Start Date : March 11, 2021
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : December 31, 2022


Group/Cohort
Hodgkin lymphoma

Diagnoses:

Hodgkin lymphoma (classical Hodgkin lymphoma)

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)

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)

Peripheral T/NK-cell

Diagnoses:

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




Primary Outcome Measures :
  1. Serum IgG levels against SARS-CoV-2 post-COVID-19 vaccination and change over time. [ Time Frame: 12 months ]
    To evaluate the robustness and persistence of anti-S IgG levels.


Secondary Outcome Measures :
  1. Comparison between SARS-CoV-2 IgG responses with clinical parameters. [ Time Frame: 12 months ]
    Correlation between anti-S IgG between different lymphoma subtypes and the impact of treatment.

  2. Symptomatic COVID-19 with positive SARS-CoV-2 PCR results. [ Time Frame: 12 months ]
    To assess the incidence of symptomatic, virologically proven COVID-19 in vaccinated individuals within 12 months of vaccine administration.


Biospecimen Retention:   Samples With DNA
Plasma Serum Peripheral blood mononuclear cells


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with a confirmed lymphoma diagnosis who is under the care of a secondary or tertiary referral centre.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04858568


Locations
Layout table for location information
United Kingdom
Bedfordshire Hospitals NHS Foundation Trust
Bedford, Bedfordshire, United Kingdom, MK42 9DJ
Portsmouth Hospitals University NHS Trust
Portsmouth, Hampshire, United Kingdom, PO6 3LY
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, SO16 6YD
Wye Valley NHS Trust
Hereford, Herefordshire, United Kingdom, HR1 2ER
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, United Kingdom, LE1 5WW
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, United Kingdom, NR4 7UY
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, United Kingdom, OX3 7LE
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE7 7DN
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust
Layout table for additonal information
Responsible Party: University Hospital Southampton NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04858568    
Other Study ID Numbers: RHM CAN1612
First Posted: April 26, 2021    Key Record Dates
Last Update Posted: October 27, 2021
Last Verified: October 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Burkitt Lymphoma
Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Hodgkin Disease
Lymphoma, Mantle-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, T-Cell, Peripheral
Waldenstrom Macroglobulinemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Leukemia
Leukemia, B-Cell
Lymphoma, T-Cell
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Infections
Tumor Virus Infections
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases