Pre-cancerous Lymphoproliferative DisordersOxPLoreDNCT04023747
Oxford Pre-cancerous Lymphoproliferative Disorders Study
An observational study of Pre-cancerous Lymphoproliferative Disorders, run by University of Oxford at 17 sites in United Kingdom.
Trial summary
OxPLoreD is an observational cohort study to identify clinical, genomic and immunological predictive markers of progression to malignant disease. Open to individuals diagnosed in the last 3 years with high count MBL, Binet Stage A CLL, Immunoglobulin G/A/M (IgG, IgA, IgM) MGUS, asymptomatic WM not requiring treatment… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pre-cancerous Lymphoproliferative Disorders
- How many people
- 574 participants
- Where
- 17 sitesUnited Kingdom
- Study dates
- 3 Jul 2019to Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study targets three groups of pre-cancerous lymphoproliferative disorders
Who may be able to join
- Patients diagnosed within the previous three years with one of the following:
- High count monoclonal B-cell lymphocytosis (MBL) i.e. clonal B-cell population 0.5-4.9 109/L
- Rai Stage 0-2/ Binet Stage A or Stage B Chronic Lymphocytic Leukaemia not meeting the IWCLL criteria for treatment
- IgG or IgA Monoclonal Gammopathy of Uncertain Significance meeting one of the following criteria:
- IgA paraprotein >10g/L or
- IgG paraprotein >15g/L or
Show all 18Show fewer
- IgA/IgG paraprotein below these cut-offs but kappa:lambda light chain ratio of
- <0.1 to >3.0 (For OUH participants or sites with no pre-defined cut offs for high risk MGUS) or
- within the cut off criteria of the local laboratory ranges for high risk MGUS
- Patients not meeting the cut-offs defined in points i) to iii) but who are referred to secondary care e.g. due to general practitioner (GP) concern or for investigation of symptoms
- IgM Monoclonal Gammopathy of Uncertain Significance meeting one of the following criteria: i) IgM paraprotein >10g/L or
- IgM paraprotein <10g/L and difference between the kappa and lambda light chains of >50mg/L
- Patients not meeting the cut-offs defined in point i) and ii) but who are referred to secondary care e.g. due to GP concern or investigation of symptoms
- Asymptomatic smouldering Waldenstrom's Macroglobulinaemia not meeting the criteria for treatment f) Smouldering myeloma not meeting the criteria for treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
- Age 16 years and over
- Sign written informed consent
- The patient is willing and able to comply with the protocol for the duration of the study and scheduled follow-up visits and examinations
Who cannot join
- Pregnant or breast-feeding women. Pregnant or breast-feeding women may be re-screened following delivery and/or cessation of breastfeeding, as appropriate
- Previous chemotherapy or immunotherapy for any haematological cancers
- Treatment with any other investigational agent, or participation in an interventional clinical trial within 28 days prior to enrolment.
- Patients in cohort 2 or 3 on anticoagulation for a diagnosis of pulmonary embolus or deep vein thrombosis within the last 3 months or with a mechanical heart valve or any other condition causing a significant risk of thromboembolism. Participants who are anticoagulated for atrial fibrillation are eligible, but will be asked to interrupt anticoagulation 3 days prior to bone marrow examination
- Other psychological, social or medical condition, physical examination finding or laboratory abnormality that the investigator considers would make the patient a poor study candidate or could interfere with protocol compliance or the interpretation of study results.
- Any other malignancy that requires active surgical or chemotherapeutic Patients on long term hormone therapies (e.g. Tamoxifen) are permitted to enrol at the discretion of investigator, after considering the overall clinical context
- Any significant concurrent medical resulting in life-expectancy (including but no limited to renal, Hepatic, haematological gastrointestinal, endocrine pulmonary neurological, cerebral or psychiatric disease
- For cohort 3: Any contraindication for MRI- presence of any metallic foreign body, eGFR <30 and allergy to gadolinium contrast
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United Kingdom17 sites
Royal Bournemouth Hospital
Bournemouth
Russells Hall Hospital
Dudley
James Paget Hospital
Great Yarmouth
Leicester Royal Infirmary
Leicester
Clatterbridge Cancer Centre
Liverpool
Epsom Hospital
London
King's College Hospital
London
St George's Hospital
London
Northern Centre for Cancer Care
Newcastle
North Tyneside General Hospital
North Shields
Queens Medical Centre
Nottingham
Churchill Hospital, Oxford University Hospitals Trust
Oxford, OX3 7LE
Derriford Hospital
Plymouth
Poole Hospital
Poole
South Tyneside District Hospital
South Shields
Sunderland Royal Hospital
Sunderland
Musgrove Park Hospital
Taunton
About this study
Official title: Oxford Pre-cancerous Lymphoproliferative Disorders: Analysis and Interception Study
OxPLoreD is an observational cohort study to identify clinical, genomic and immunological predictive markers of progression to malignant disease. Open to individuals diagnosed in the last 3 years with high count MBL, Binet Stage A CLL, Immunoglobulin G/A/M (IgG, IgA, IgM) MGUS, asymptomatic WM not requiring treatment and smouldering myeloma not requiring treatment.
Read the detailed description
The purpose of the study is to monitor patients with early stage lymphoproliferative disorders not meeting criteria for treatment, including early stage Chronic Lymphocytic Leukaemia (CLL), Monoclonal B-cell Lymphocytosis (MBL), Monoclonal Gammopathy of Uncertain Significance (MGUS), asymptomatic Waldenstroms Macroglobulinaemia (WM) and Smouldering Myeloma (SM).
Each of these disorders has a pre-cancerous phase when abnormalities can be seen in the blood, however treatment may not be required. A minority of people with early stage lymphoproliferative disorders will go on to need treatment for blood or bone marrow cancer.
Currently the investigators do not have a reliable way to predict which of these individuals with these disorders are more likely to develop a blood or bone marrow cancer. By studying a large group of individuals over time we hope to discover more about what factors might predict progression. The investigators may be able to identify markers which identify individuals who are more or less likely to develop blood or bone marrow cancer. These markers might be particular symptoms, gene changes called mutations or levels of particular molecules or cells in the blood or bone marrow. In the longer term this may enable us to identify those people who would benefit from certain types of treatment or from receiving treatment at an earlier stage and also to confidently reassure those who will never progress.
Patients will be studied for up to 5 years with blood, bone marrow and saliva samples taken at key time-points to help answer these questions. In addition to looking for these markers we will also collect information about:
- What it is like to live with one of these conditions
- How many people with these conditions develop other significant medical conditions, such as serious infections, thrombosis (blood clots) or other types of cancer.
- Keywords
- Monoclonal B-Cell Lymphocytosis, Asymptomatic Chronic Lymphocytic Leukaemia, IgM Monoclonal Gammopathy, Asymptomatic Waldenstrom's Macroglobulinaemia, Immunoglobulin A or G Monoclonal Gammopathy, Smouldering Myeloma, Pre-cancerous, Lymphoproliferative Disorders
- Medical subject headings
- Smoldering Multiple Myeloma, Lymphoproliferative Disorders
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 |
|---|---|---|
| Cohort 1 | Participants with Monoclonal B-Cell Lymphocytosis or Asymptomatic Chronic Lymphocytic Leukaemia | |
| Cohort 2 | Participants with IgM Monoclonal Gammopathy or Asymptomatic Waldenstrom's Macroglobulinaemia | |
| Cohort 3 | Participants with IgA or IgG Monoclonal Gammopathy or Smouldering Myeloma |
What is being measured
The primary outcome is the main question the study is designed to answer.
The identification of predictive markers of progression to malignant disease
Relevant markers will be identified from the analysis of the clinical data in combination with the genomic and immunological data from the samples collected. The markers will be combined to produce a single probability risk score. The choice of relevant markers will be guided by emerging evidence and techniques under the guidance of the study scientific advisory board.
Measured: Duration of the study (5 years)
Secondary outcomes (6)
Patient reported outcome measures (PROM) via approved quality of life questionnaires.
Analysis of approved questionnaires: EORTC CLL17
Measured: Duration of study (5 years)
To study other clinically significant events, not inevitably due to disease progression in this patient cohort
Assessed by analysing suspected unexpected serious adverse reactions (SUSARs) reported
Measured: Duration of study (5 years)
Production of evidence-based standard of care guidelines for the monitoring and follow-up of patients with these pre-cancerous conditions
The identification of relevant markers can be used to create guidelines for optimal monitoring of patients with these pre-cancerous conditions
Measured: Duration of study (5 years)
Patient reported outcome measures (PROM) via approved quality of life questionnaires.
Analysis of approved questionnaires: EORTC NHL-LG20
Measured: Duration of study (5 years)
Patient reported outcome measures (PROM) via approved quality of life questionnaires.
Analysis of approved questionnaires: EORTC QLQ-C30
Measured: Duration of study (5 years)
Patient reported outcome measures (PROM) via approved quality of life questionnaires.
Analysis of approved questionnaires: EORTC QLQ-MY20
Measured: Duration of study (5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start3 Jul 2019
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-cancerous Lymphoproliferative DisordersStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- 574 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Research & Development, LLC
- Responsible party
- Sponsor
- Investigators
- Anna Schuh, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023747
- Sponsor's protocol ID
- OCTO_091
- Acronym
- OxPLoreD
- Status last verified
- Oct 2024
- First submitted
- 25 Jun 2019
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxford Pre-cancerous Lymphoproliferative Disorders: Analysis and Interception Study
- ClinicalTrials.gov ID
- NCT04023747
- Acronym / sponsor ID
- OxPLoreD / OCTO_091
- Keywords
- Monoclonal B-Cell Lymphocytosis, Asymptomatic Chronic Lymphocytic Leukaemia, IgM Monoclonal Gammopathy, Asymptomatic Waldenstrom's Macroglobulinaemia, Immunoglobulin A or G Monoclonal Gammopathy, Smouldering Myeloma, Pre-cancerous, Lymphoproliferative Disorders
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 574 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Janssen Research & Development, LLC
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 17 Jul 2019 (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.
OxPLoreD is an observational cohort study to identify clinical, genomic and immunological predictive markers of progression to malignant disease. Open to individuals diagnosed in the last 3 years with high count MBL, Binet Stage A CLL, Immunoglobulin G/A/M (IgG, IgA, IgM) MGUS, asymptomatic WM not requiring treatment and smouldering myeloma not requiring treatment.
Detailed description
The purpose of the study is to monitor patients with early stage lymphoproliferative disorders not meeting criteria for treatment, including early stage Chronic Lymphocytic Leukaemia (CLL), Monoclonal B-cell Lymphocytosis (MBL), Monoclonal Gammopathy of Uncertain Significance (MGUS), asymptomatic Waldenstroms Macroglobulinaemia (WM) and Smouldering Myeloma (SM).
Each of these disorders has a pre-cancerous phase when abnormalities can be seen in the blood, however treatment may not be required. A minority of people with early stage lymphoproliferative disorders will go on to need treatment for blood or bone marrow cancer.
Currently the investigators do not have a reliable way to predict which of these individuals with these disorders are more likely to develop a blood or bone marrow cancer. By studying a large group of individuals over time we hope to discover more about what factors might predict progression. The investigators may be able to identify markers which identify individuals who are more or less likely to develop blood or bone marrow cancer. These markers might be particular symptoms, gene changes called mutations or levels of particular molecules or cells in the blood or bone marrow. In the longer term this may enable us to identify those people who would benefit from certain types of treatment or from receiving treatment at an earlier stage and also to confidently reassure those who will never progress.
Patients will be studied for up to 5 years with blood, bone marrow and saliva samples taken at key time-points to help answer these questions. In addition to looking for these markers we will also collect information about:
- What it is like to live with one of these conditions
- How many people with these conditions develop other significant medical conditions, such as serious infections, thrombosis (blood clots) or other types of cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Participants with Monoclonal B-Cell Lymphocytosis or Asymptomatic Chronic Lymphocytic Leukaemia |
| Cohort 2 | – | –Participants with IgM Monoclonal Gammopathy or Asymptomatic Waldenstrom's Macroglobulinaemia |
| Cohort 3 | – | –Participants with IgA or IgG Monoclonal Gammopathy or Smouldering Myeloma |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study targets three groups of pre-cancerous lymphoproliferative disorders
Key inclusion criteria (18 listed)
- Patients diagnosed within the previous three years with one of the following:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
- Age 16 years and over
- Sign written informed consent
- The patient is willing and able to comply with the protocol for the duration of the study and scheduled follow-up visits and examinations
Key exclusion criteria (8 listed)
- Pregnant or breast-feeding women. Pregnant or breast-feeding women may be re-screened following delivery and/or cessation of breastfeeding, as appropriate
- Previous chemotherapy or immunotherapy for any haematological cancers
- Treatment with any other investigational agent, or participation in an interventional clinical trial within 28 days prior to enrolment.
- Patients in cohort 2 or 3 on anticoagulation for a diagnosis of pulmonary embolus or deep vein thrombosis within the last 3 months or with a mechanical heart valve or any other condition causing a significant risk of thromboembolism. Participants who are anticoagulated for atrial fibrillation are eligible, but will be asked to interrupt anticoagulation 3 days prior to bone marrow examination
- Other psychological, social or medical condition, physical examination finding or laboratory abnormality that the investigator considers would make the patient a poor study candidate or could interfere with protocol compliance or the interpretation of study results.
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
The identification of predictive markers of progression to malignant disease
Time frame: Duration of the study (5 years)
Relevant markers will be identified from the analysis of the clinical data in combination with the genomic and immunological data from the samples collected. The markers will be combined to produce a single probability risk score. The choice of relevant markers will be guided by emerging evidence and techniques under the guidance of the study scientific advisory board.
6 secondary outcomes
Patient reported outcome measures (PROM) via approved quality of life questionnaires.
Time frame: Duration of study (5 years)
To study other clinically significant events, not inevitably due to disease progression in this patient cohort
Time frame: Duration of study (5 years)
Production of evidence-based standard of care guidelines for the monitoring and follow-up of patients with these pre-cancerous conditions
Time frame: Duration of study (5 years)
Patient reported outcome measures (PROM) via approved quality of life questionnaires.
Time frame: Duration of study (5 years)
Patient reported outcome measures (PROM) via approved quality of life questionnaires.
Time frame: Duration of study (5 years)
Patient reported outcome measures (PROM) via approved quality of life questionnaires.
Time frame: Duration of study (5 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Individual participant dataSharing planned: Undecided
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.
Anna Schuh principal investigator
University of Oxford
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-cancerous Lymphoproliferative Disorders, run by University of Oxford at 17 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 18 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
This study is still under way. Results are not available in the source record yet.
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?
The identification of predictive markers of progression to malignant disease (time frame: Duration of the study (5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2025.