Purpose of study
Only 1 in 20 people with pre-cancerous blood conditions are likely to go on to develop blood or bone marrow cancer. The aim of this study is to find a more precise way to predict which people are likely to be affected by blood or bone marrow cancer. The remaining 19 in every 20 could be reassured.
What is involved
The study will monitor people with early-stage pre-cancerous blood conditions that do not currently need treatment. This will include people with early-stage chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL), monoclonal B-cell lymphocytosis (MBL), monoclonal gammopathy of uncertain significance (MGUS), early stage myeloma and Waldenström’s macroglobulinaemia (WM) that is not causing any symptoms.
Participants will be studied for up to 5 years with study visits at the beginning, after 2 years and at disease progression. They will be asked about what it is like to have an early-stage pre-cancerous blood condition. The researchers will also collect information about any other health problems participants have.
Who can enter
Your consultant can give you advice on whether you might be suitable for this trial.
Around 1,650 people are needed for this trial.
You may be able to enter if:
- You have been diagnosed within the last 3 years with:
- monoclonal B-cell lymphocytosis (MBL) with a high B-cell count
- low-risk (stage A or stable stage B) CLL or SLL that does not need treatment
- monoclonal gammopathy of uncertain significance (MGUS) with specific levels of paraprotein in your blood (the exact level depends on the type of gammopathy you have)
- smouldering myeloma
- Waldenström’s macroglobulinaemia that is not causing any symptoms and does not need treatment.
- You are well enough to take part in the study.
- Your blood and other health test results are satisfactory.
- You are willing and able to attend any appointments or tests that are needed.
- You are 16 or over.
You won’t be able to enter if:
- You have any serious health problems that might affect your life expectancy.
- You’ve ever had chemotherapy or immunotherapy for blood cancer.
- You are having active treatment for any other cancer (apart from long-term hormone treatment, such as tamoxifen for breast cancer).
- You’ve had treatment as part of a clinical trial in the last 28 days.
- You are pregnant or breastfeeding. (You may be able to join the study once you are no longer pregnant or breastfeeding.)
- You have any issues that would make it difficult for you to take part in the study or attend appointments or tests.
More information about this trial is available at clinicaltrials.gov/ct2/show/NCT04023747.