Classical Hodgkin LymphomaPROSECONCT04858568
Immune Responses to COVID-19 Vaccination in Lymphoma Patients
An observational study of Classical Hodgkin Lymphoma and Diffuse Large B Cell Lymphoma, run by University Hospital Southampton NHS Foundation Trust at 9 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Classical Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Primary Mediastinal B Cell Lymphoma
- How many people
- 592 participants
- Where
- 9 sitesUnited Kingdom
- Study dates
- 11 Mar 2021to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with a confirmed lymphoma diagnosis who is under the care of a secondary or tertiary referral centre.
Who may be able to join
- Patients having a confirmed diagnosis of either:
- 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)
- Patient must be ≥ 18 years.
- Patients will have provided written Informed Consent.
Who cannot join
- 1) Serious medical or psychiatric illness likely to affect participation or that may compromise the ability to give informed consent.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United Kingdom9 sites
Bedfordshire Hospitals NHS Foundation Trust
Bedford, Bedfordshire, MK42 9DJ
Wye Valley NHS Trust
Hereford, Herefordshire, HR1 2ER
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, LE1 5WW
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Tyne and Wear, NE7 7DN
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, NR4 7UY
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, NG7 2UH
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, OX3 7LE
Portsmouth Hospitals University NHS Trust
Portsmouth, Hampshire, PO6 3LY
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD
About this study
Official title: PROSECO - A UK Multicentre Prospective Observational Study Evaluating COVID-19 Vaccine Immune Responses in Lymphoid Cancer
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.
- Conditions
- Classical Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Primary Mediastinal B Cell Lymphoma, High-grade B-cell Lymphoma, Burkitt Lymphoma, Follicular Lymphoma
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Burkitt Lymphoma, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone, Leukemia, Lymphocytic, Chronic, B-Cell, Hodgkin Disease, Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
Comparison between SARS-CoV-2 IgG responses with clinical parameters.
Correlation between anti-S IgG between different lymphoma subtypes and the impact of treatment.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start11 Mar 2021
- Primary completion31 Oct 2022
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Classical Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 592 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858568
- Sponsor's protocol ID
- RHM CAN1612
- Acronym
- PROSECO
- Status last verified
- Feb 2024
- First submitted
- 22 Apr 2021
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35332334
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSECO - A UK Multicentre Prospective Observational Study Evaluating COVID-19 Vaccine Immune Responses in Lymphoid Cancer
- ClinicalTrials.gov ID
- NCT04858568
- Acronym / sponsor ID
- PROSECO / RHM CAN1612
- Conditions
- Classical Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, Primary Mediastinal B Cell Lymphoma, High-grade B-cell Lymphoma, Burkitt Lymphoma, Follicular Lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 592 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with a confirmed lymphoma diagnosis who is under the care of a secondary or tertiary referral centre.
Key inclusion criteria (4 listed)
- Patients having a confirmed diagnosis of either:
- Patient must be ≥ 18 years.
- Patients will have provided written Informed Consent.
Key exclusion criteria (1 listed)
- 1) Serious medical or psychiatric illness likely to affect participation or that may compromise the ability to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Comparison between SARS-CoV-2 IgG responses with clinical parameters.
Time frame: 12 months
Symptomatic COVID-19 with positive SARS-CoV-2 PCR results.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Derived from this study: PubMed 35332334Lim 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.
Related trials for Classical Hodgkin Lymphoma
RecruitingPhase 3
A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8
Active, not recruitingPhase 2
Safety and Efficacy of Pembrolizumab (MK-3475) in Children and Young Adults With Classical Hodgkin Lymphoma (MK-3475-667/KEYNOTE-667)
Hodgkin Lymphoma
Active, not recruitingPhase 1
Pembrolizumab and Vorinostat in Patients With Relapsed or Refractory DLBCL, FCL or HL.
Grade 3b Follicular Lymphoma, Recurrent B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between DLBCL and Classic HL
Active, not recruitingPhase 3
Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma
Ann Arbor Stage IIB Hodgkin Lymphoma, Ann Arbor Stage IIIB Hodgkin Lymphoma
RecruitingPhase 1/2
Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma
Hodgkin Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Classical Hodgkin Lymphoma and Diffuse Large B Cell Lymphoma, run by University Hospital Southampton NHS Foundation Trust at 9 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum IgG levels against SARS-CoV-2 post-COVID-19 vaccination and change over time. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04858568, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.