A study to find out more about the causes of some types of lymphoma and chronic leukaemia

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Cancer type:

Blood cancers
Chronic leukaemia
Chronic lymphocytic leukaemia (CLL)
Hairy cell leukaemia
Leukaemia
Low grade lymphoma
Lymphoma
Non-Hodgkin lymphoma

Status:

Open

Phase:

Other

This study is looking at blood, bone marrow, tissue and spit (saliva) samples from people with white blood cell (lymphocyte) disorders, to discover more about the causes and possible future treatments.

More about this trial

Conditions where lymphocytes have become cancerous are called lymphoproliferative disorders and include

Doctors want to find out more about these cancerous cells. In this study you will give samples of blood and any extra bone marrow Open a glossary item , lymph node Open a glossary item or any otyher tissue you may have removed during routine procedures. You will also give a sample of spit (saliva). Researchers will look at both abnormal and normal cells in these samples. They will look for genes, including a particular gene called the ‘immunoglobulin gene’ that help the cancer cell to survive. And, for other gene and chromosome changes that may in future help them predict the outcome of these diseases.

The aim of this study is to understand more about how changes to certain genes, proteins and sugars could affect how these diseases develop.  This may help develop new treatments for these conditions in future.

You will not have any direct benefit from taking part in this study, and it is unlikely to change your treatment plan in any way. But the results of the study will be used to help people with cancer in the future.

Who can enter

You can enter this study if you have any of the following cancers

Trial design

Everyone taking part will have a study blood test at the time they are diagnosed, and when you come to the hospital for your follow up appointments, so the team can monitor changes in the blood cells. You will also give a sample of spit (saliva).

The team will ask permission to study any stored samples of bone marrow or lymphatic tissue that you have had removed as part of your routine treatment.  They will also look at your medical notes to see how you are getting on.

Hospital visits

You will have your study blood test and give your saliva sample when you are already at the hospital for your follow up appointments. So you will not need to make any extra visits to hospital.

Side effects

As there are no treatments in this study, there are no side effects. You may have a small bruise where you had your blood tests.

Location

Southampton

Early results

The research team have published several results from the trial. They do not have the full results for the trial yet. 

The study is ongoing and the team will publish more results at a later date. We hope to update this page once more results are available.

This is a summary of the most recent results published in conjunction with an International Consortium of CLL investigators around the world.

Results
This is an international study and 4,933 people from around the world are taking part. 

The researchers looked at developing a score for early stage CLL to predict how likely it was for someone to need first treatment. For early stage CLL doctors monitor you with regular blood tests to check your blood count Open a glossary item

In this part of the study researchers looked at 3 features of CLL:

  • a gene Open a glossary item called the unmutated (unchanged) immunoglobulin heavy variable gene (IHVG)
  • the total number of lymphocytes Open a glossary item in the blood 
  • when doing a physical examination whether the doctor can feel lymph nodes Open a glossary item

They call this the International Prognostic Score for Early stage CLL (IPS-E). Each feature scored 1 point. The total score showed how likely it was the person needed to start their first treatment:

  • 0 meant there was a low chance
  • 1 meant there was a middle (intermediate) chance
  • 2 or 3 meant there was a high chance

The team checked the IPS-E against the 2 current systems for staging CLL. They looked at 10 groups of people with CLL and when they first needed treatment. 

They found that the IPS-E was accurate and did predict the likelihood of someone with CLL needing their first treatment. 

Conclusion
The team concluded that the IPS-E is a simple and strong model to predict the chances of someone with CLL needing their first treatment. They say it is useful for doctors when managing people with CLL. And also to use in clinical trials that are looking at the early treatment and management of people with CLL.

Where this information comes from    
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Francesco Forconi

Supported by

Cancer Research UK
Blood Cancer UK
Experimental Cancer Medicine Centre (ECMC)
University Hospital Southampton NHS Foundation Trust

Freephone 0808 800 4040

Last review date

CRUK internal database number:

2349

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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