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Oxford Pre-Cancerous Lymphoproliferative Disorders: Analysis and Interception study

OxPLoreD_Logo_V1.0_Apr2018.jpg


 

 

 

 

FULL TITLE

Oxford Pre-Cancerous Lymphoproliferative Disorders: Analysis and Interception study 

Chief Investigator: Professor Anna Schuh

Sponsor: University of Oxford                       

Trial website, including information for participants: https://oxplored.oncology.ox.ac.uk/

 

STUDY DESIGN

OxPLoreD is an observational cohort study

STUDY POPULATION

The study targets 3 groups of early lymphoproliferative disorders:

  • Monoclonal B-cell lymphocytosis and asymptomatic Chronic Lymphocytic Leukaemia
  • IgM Monoclonal gammopathy and asymptomatic Waldenström’s macroglobulinaemia
  • IgA or IgG Monoclonal gammopathy and smouldering myeloma  

STUDY STATUS

 Open for recruitment

TARGET RECRUITMENT:

1650 participants Total

CURRENT RECRUITMENT

None

PARTICIPATING SITE

Churchill Hospital – Oxford University Hospital Trust

Inclusion  Criteria

1. Patients diagnosed within the previous three years with one of the following:

a. High count monoclonal B-cell lymphocytosis (MBL) i.e. clonal B-cell population 0.5-4.9 109/L,

b. Rai Stage 0-2/ Binet Stage A or Stage B Chronic Lymphocytic Leukaemia not meeting the IWCLL criteria for treatment

c. IgG or IgA Monoclonal Gammopathy of Uncertain Significance 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 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 for investigation of symptoms

e. Asymptomatic smouldering Waldenström’s Macroglobulinaemia not meeting the criteria for treatment

f. Smouldering myeloma not meeting the criteria for treatment

2. ECOG performance status of 0,1 or 2

3. Age 16 years and over

4. Signed written informed consent

5. The patient is willing and able to comply with the protocol for the duration of the study, and scheduled follow-up     visits and examinations.

6. Haematological and biochemical indices within acceptable ranges

 

Exclusion Criteria

1.   Pregnant or breast-feeding women. Pregnant or breast-feeding women may be re-screened following delivery and/or cessation of breastfeeding, as appropriate.

2.   Previous chemotherapy or immunotherapy for any haematological cancers

3.   Treatment with any other investigational agent, or participation in an interventional clinical trial within 28 days prior to enrolment.

4.   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.

5.   Other psychological, social or medical condition, physical examination finding or a 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.

6.   Any other malignancy that requires active surgical or chemotherapeutic treatment.  Patients on long term hormone therapies (e.g. tamoxifen) are permitted to enrol at the discretion of the investigator, after considering the overall clinical context.

7.   Any significant concurrent medical condition resulting in a life-expectancy of less than 5 years (including but not limited to renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease)

8.   For cohort 3: Any contraindication for MRI- presence of any metallic foreign body, eGFR <30 and allergy to gadolinium contrast

 

OBJECTIVES

PRIMARY OBJECTIVE

  • To identify the clinical, genomic and immunological predictive markers of progression to malignant disease

SECONDARY OBJECTIVES

  • To assess Quality of Life of patients with pre-cancerous lymphoid conditions
  • To study other clinical complications associated with pre-malignancy (infection, bony fractures, thrombosis and deaths not to progression to lymphoid cancers)
  • To establish evidence-based guidance for monitoring and follow-up of patients with pre-cancerous conditions

EXPLORATORY OBJECTIVES

  • To identify novel surrogate markers of cure
  • To gather feasibility data in this subgroup at high-risk of progression to inform a future early intervention trial

 

KEY DATES

Open to recruitment: July 2019

End of recruitment: May 2024

End of Trial: May 2026

 

DATA SUBMISSION

Data submission for this trial is via electronic submission of the data into OpenClinica

 

CONTACT US

OxPLoreD Trial office

Tel: +44 (0)1865 617087

Email: octo-oxplored@oncology.ox.ac.uk

 

 

 

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