Oxford Pre-cancerous Lymphoproliferative Disorders Study (NCT04023747) | Clinical Trial Compass
Active ā Not RecruitingNot Applicable
Oxford Pre-cancerous Lymphoproliferative Disorders Study
United Kingdom574 participantsStarted 2019-07-03
Plain-language 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 and smouldering myeloma not requiring treatment.
Who can participate
Age range16 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Patients diagnosed within the previous three years with one of the following:
ā. High count monoclonal B-cell lymphocytosis (MBL) i.e. clonal B-cell population 0.5-4.9 109/L
ā. Rai Stage 0-2/ Binet Stage A or Stage B Chronic Lymphocytic Leukaemia not meeting the IWCLL criteria for treatment
ā. IgG or IgA Monoclonal Gammopathy of Uncertain Significance meeting one of the following criteria:
ā. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
ā. Age 16 years and over
ā. Sign written informed consent
ā. 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 criteria
ā. Pregnant or breast-feeding women. Pregnant or breast-feeding women may be re-screened following delivery and/or cessation of breastfeeding, as appropriate
ā. Previous chemotherapy or immunotherapy for any haematological cancers
ā. Treatment with any other investigational agent, or participation in an interventional clinical trial within 28 days prior to enrolment.
ā. 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
What they're measuring
1
The identification of predictive markers of progression to malignant disease
ā. 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.
ā. 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
ā. Any significant concurrent medical resulting in life-expectancy (including but no limited to renal, Hepatic, haematological gastrointestinal, endocrine pulmonary neurological, cerebral or psychiatric disease
ā. For cohort 3: Any contraindication for MRI- presence of any metallic foreign body, eGFR \<30 and allergy to gadolinium contrast