Status:
ACTIVE_NOT_RECRUITING
Oxford Pre-cancerous Lymphoproliferative Disorders Study
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Janssen Research & Development, LLC
Conditions:
Pre-cancerous Lymphoproliferative Disorders
Eligibility:
All Genders
16+ years
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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:
- i) IgA paraprotein \>10g/L or
- ii) IgG paraprotein \>15g/L or
- iii) 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
- iv) 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
- d. IgM Monoclonal Gammopathy of Uncertain Significance meeting one of the following criteria: i) IgM paraprotein \>10g/L or
- ii) IgM paraprotein \<10g/L and difference between the kappa and lambda light chains of \>50mg/L
- iii) 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
- e) 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
Exclusion
- 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
Key Trial Info
Start Date :
July 3 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
574 Patients enrolled
Trial Details
Trial ID
NCT04023747
Start Date
July 3 2019
End Date
October 1 2025
Last Update
February 3 2025
Active Locations (17)
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1
Royal Bournemouth Hospital
Bournemouth, United Kingdom
2
Russells Hall Hospital
Dudley, United Kingdom
3
James Paget Hospital
Great Yarmouth, United Kingdom
4
Leicester Royal Infirmary
Leicester, United Kingdom