A study to develop a blood test to predict how well treatment is working for B cell lymphoma (DIRECT)

Cancer type:

Blood cancers

High grade lymphoma

Lymphoma

Non-Hodgkin lymphoma

Status:

Open

Phase:

Pilot

This study is looking at blood and tissue samples in people having their first treatment for B cell lymphoma.

It is for people who have fast growing B cell lymphoma. This is called high grade lymphoma.

More about this trial

B cell lymphomas are a type of high grade non-Hodgkin lymphoma. A usual first treatment for high grade lymphoma includes chemotherapy and a drug such as rituximab.

These treatments work well for most people. But for some treatment doesn’t work or the lymphoma comes back soon after.

Researchers want to find out early on who has a high risk of the lymphoma coming back. To do this they plan to look for gene changes (mutations Open a glossary item ) in blood and tissue samples. In the blood samples they look for ctDNA.

Cells within the body contain genetic information stored in the form of DNA Open a glossary item . Cancer can release DNA into the bloodstream. This is called circulating tumour DNA or ctDNA.

The main aim of this study is to find out if it’s possible to use the ctDNA in blood samples to:

find these gene changes
help track if treatment is working early on

Please note – you won’t benefit directly if you take part in this trial. But it might help people diagnosed with lymphoma in the future. For example it might help doctors predict if someone would benefit from a particular treatment or not.

Who can enter

The following bullet points list 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 may be able to join this study if all of the following apply.
You:

have high grade B cell lymphoma, for example diffuse large B cell lymphoma
are due to have your first treatment that includes chemotherapy and rituximab
have had or are having a CT scan or PET-CT before starting treatment
can give blood samples
are at least 18 years old

Who can’t take part

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

aren’t able to have a combination of treatment that includes chemotherapy and rituximab or you decide not to have this treatment
have already started high dose steroids to treat the lymphoma
are known to have hepatitis B, hepatitis C or HIV

Trial design

This study is running in the UK. The researchers need about 150 people to take part.

The study isn’t looking at new treatments. It runs alongside the first treatment you are having for lymphoma.

You have the standard treatment your doctor prescribes. This might include a combination of chemotherapy and rituximab called R-CHOP. Your doctor tells you about your treatment and how long you have it for.

Blood samples
You give 6 extra blood tests as part of this study. You give them:

before starting treatment
during treatment
when you finish treatment
at set timepoints after that

Where possible you have them at the same time as your routine blood tests.

Tissue samples
The team ask to have:

a sample of your lymphoma (biopsy) from when you were first diagnosed
a piece of any samples you give as a part of treatment

They also ask some people to give 1 extra tissue sample. But you don’t have to agree to this if you don’t want to. It won’t affect you taking part in the research.

Other information
The team also collect information from:

routine scans such as CT scans you have during treatment and afterwards
your medical notes about your medical history and how your treatment is working

The researchers look at your scans and test results. They compare them with the gene changes they find in your blood and tissue samples. This helps them to build up a detailed picture of your lymphoma. And how your treatment is working.

The team follow you up for 3 years after treatment. They check your medical notes to see how you are getting on or they may contact your GP.