A study to find out more about early stage lymphoproliferative disorders (OxPLoreD)

Cancer type:

Blood cancers

Chronic leukaemia

Chronic lymphocytic leukaemia (CLL)

Leukaemia

Myeloma

Status:

Open

Phase:

Other

The aim of this study is to learn more about early stage and precancerous Open a glossary item lymphoproliferative disorders.

Researchers would like to look at the differences between:

conditions that have got worse (progressed)
those that have stayed the same

More about this trial

Lymphocytes are a type of white blood cell. They form part of your immune system Open a glossary item . Lymphoproliferative disorders start when there is a problem with the growth or development of lymphocytes.

Most people with these early stage conditions do not have any serious problems with their health. But a small number of people go on to develop blood cancer or bone marrow Open a glossary item cancer.

At the moment, we don’t know which people with early stage conditions are more likely to go on to develop one of these cancers. The study team aim to find out more about factors which could help them to predict who might go on to develop cancer.

The researchers think these factors could include:

symptoms
gene changes inside cells (mutations )
levels of particular substances inside cells , blood or bone marrow

The other aims of the study are to find out:

more about quality of life
how many people with these conditions develop a serious medical problem. This might be blood clots, some types of infections or another type of cancer.

In the future, results of this trial might help doctors identify:

people who would benefit from certain types of treatment
those who might benefit from treatment at an earlier stage.

It might also help doctors reassure people whose lymphoproliferative disorder is unlikely to get worse.

In the future the information might also help doctors develop new treatments for blood and bone marrow cancers.

Please note - you won’t get any direct benefit from taking part in this study, nor will it affect any treatment you have. But may it help people in the future.

Who can enter

The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Who can take part

You are put into one of three groups depending on your type of lymphoproliferative disorder.

You can take part if you have been diagnosed in the last 3 years with one of the following:

high count monoclonal B-cell lymphocytosis (MBL)
chronic lymphocytic leukaemia that is Binet stage A or B or Rai stage 0-2 and you haven’t needed treatment so far
some types of IgG, IgA or IgM monoclonal gammopathy of uncertain significance
Waldenström’s macroglobulinaemia (WM) if you have no symptoms and have not needed treatment so far
myeloma without symptoms (smouldering myeloma) and you haven’t needed treatment so far

And if all of the following apply. You:

can look after yourself and are up and about for half the day (performance status 0, 1 or 2)
are willing and able to take part in the study, including tests, investigations and appointments at the hospital
are at least 16 years old

Who can’t take part

You cannot join this study if any of these apply. You:

have had chemotherapy or immunotherapy for a blood cancer in the past
have had a trial drug or used a healthcare product as part of another clinical trial or study in the 28 days before joining this study
have another cancer and you need chemotherapy or surgery. You may be able to take part if you are taking hormone therapy , for example tamoxifen. Your doctor will explain more.
are in group 3 and can’t have an MRI scan. For example you have metal anywhere in your body that cannot be removed, or you are allergic to the dye used in MRI scans.
are in group 2 or 3 and you have a mechanical heart valve, or you have another condition meaning you are high risk for a blood clot. You may be able to take part if you take blood thinners for an irregular and fast heart rate (atrial fibrillation).
have another medical problem which means you are not expected to live for more than 5 years
have any other medical problem, mental health condition or have any test results that the study team think could affect you taking part
are pregnant or breastfeeding - you may be able to join the study after your pregnancy or when you have finished breastfeeding

Trial design

The study team would like around 1,650 people to take part.

You are put into one of three groups depending on your type of lymphoproliferative disorder. This is because the tests, and samples you give, are slightly different for each group.

Group 1

chronic lymphocytic leukaemia (CLL)
monoclonal B-cell lymphocytosis (MBL)

Group 2

IgM monoclonal gammopathy of uncertain significance (MGUS)
early stage Waldenström’s macroglobulinaemia (WM)

Group 3

IgG or IgA monoclonal gammopathy of uncertain significance (MGUS)
smouldering myeloma

Everyone gives samples during the study.

These samples might include:

blood tests
urine tests
bone marrow samples

Doctors and scientists will look at samples from people whose condition has progressed over the course of the study. They compare these samples to people whose condition has stayed the same (stable).

Quality of life

The study team will ask you to fill out a questionnaire each time you meet with them. You are also asked to fill out a questionnaire if your condition progresses.

The questionnaires will ask about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You continue to have your usual monitoring while taking part in the study. This means if you are having a telephone or face-to-face appointment with your specialist every 6 to12 months this will carry on. Or if you usually just see your GP, this will continue.

Any hospital visits as part of the study are extra to your usual care.

You see the study team and have some tests before you join the study. The tests include:

a physical examination
height and weight
blood tests
a blood or urine pregnancy test, if there is a chance you could become pregnant
a urine test if you have monoclonal gammopathy of uncertain significance (MGUS), Waldenström’s macroglobulinaemia (WM) or smouldering myeloma
a spit (saliva) test if you have monoclonal B-cell lymphocytosis (MBL), stage A chronic lymphocytic leukaemia (CLL), IgM monoclonal gammopathy of uncertain significance (MGUS) or Waldenström’s macroglobulinaemia (WM)
a bone marrow test – you do not have to have this to take part in the study. But you are likely to have a bone marrow test as part of your usual care if you are in group 2 or group 3.
a scan such as a CT scan or MRI scan – you do not have to have this to take part in the study if you are in group 1 and 2. You will need to have an MRI scan unless you have had one in the last year if you are in group 3. If you have had a scan in the last year, the study team will see if this is suitable to use first.

The study team will call you after one year to check you are still happy to take part and answer any questions.

You see the study team 2 years after your first visit. And then 5 years after your first visit. You have some tests at these visits. These include:

a physical examination
blood tests
urine test if you have monoclonal gammopathy of uncertain significance (MGUS), Waldenström’s macroglobulinaemia (WM) or smouldering myeloma

The study team ask you about any new medications and check how you are getting on.
For some people, the study will have closed before they get to their 5 year visit. The study team will write to you and let you know that you don’t need to come to any more appointments if this is the case.

Condition progression visit

The study team would like to see you if your condition progresses while you are taking part. You might find out about the progression from one of the study tests. Or as part of your routine care. The team will check how you are getting on.
You also have some tests. These depend on the type of lymphoproliferative disorder you have and what group you are in. They might include:

a physical examination
blood and urine tests - including a pregnancy test if this is suitable for you
a bone marrow test
scans - such as an MRI scan or CT scan

It’s likely you will have finished taking part in the study after your condition progression visit. If you still do not need treatment at this point and you’re still happy to take part in the study, the study team will explain what will happen.

Extra bone marrow samples

The study team will ask if you are happy to give extra bone marrow samples for the study. This would be at your first visit and at your progression visit (if you have one). These samples give researchers more information about the progression of lymphoproliferative disorders.

Side effects

The extra tests you have as part of the study are common and safe tests.

It’s possible you might have some possible bleeding or bruising from the blood samples.

The most common side effect of having a bone marrow test is some pain. Your doctor gives you some local anaesthetic Open a glossary item to try and prevent this.

An MRI is very safe and doesn’t use radiation. Some people can’t have an MRI but the checklist picks this up beforehand. Allergic reactions to the dye used in an MRI is rare.

A CT scan is a safe test for most people. Your doctor and radiographer make sure the benefits of having the test outweigh these risks. Exposure to radiation during a CT scan can slightly increase your risk of developing cancer in the after many years. Talk to your doctor if this worries you.

We have detailed information on the following tests and scans, including possible risks and side effects: