A study to understand more about the growth and treatment of a rare type of non Hodgkin's lymphoma (IELSG 26)

Please note this trial is no longer recruiting patients.

This study will look at tissue samples and PET scans to learn more about a type of non Hodgkin’s lymphoma called ‘primary mediastinal diffuse large B cell lymphoma’ (PMBL), and the best way to treat it.

Diffuse large B cell lymphoma (DLBCL) is a type of high grade non Hodgkin’s lymphoma. ’Mediastinal’ means it started in the glands (lymph nodes) in the centre of the chest (the ‘mediastinum’).

Doctors often treat PMBL with chemotherapy and a monoclonal antibody called rituximab. You could have one of several chemotherapy combinations. After this, you may also have radiotherapy to your chest. Doctors want to find the best treatment plan for PMBL. Researchers will study a sample of your lymphoma tissue. They will also study PET scans taken before and after chemotherapy. The aims of this study are to

Understand more about PMBL and the best way to treat it
See if PET scans will be useful in showing how well the treatment has worked

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 will be used to help people with cancer in the future.

Recruitment

Start 15/01/2009

End 15/05/2010

Phase

Phase 2/3

Who can enter

You can enter this study if you

Have a type of non Hodgkin’s lymphoma called ‘primary mediastinal large B cell lymphoma’ (PMBL)
Have a protein called ‘CD20' on your lymphoma cells
Have the main part of your lymphoma in the front of the part of your chest called the mediastinum - you can check this with your doctor
Have not had treatment for lymphoma before (if you have taken steroids for one week to control symptoms you may still be able to take part - please note: you must never stop steroid treatment without talking to your doctor first)
Have satisfactory blood tests
Are well enough to take part
Are willing to have PET scans
Are willing to use reliable contraception if there is any chance that you or your partner could become pregnant
Are at least 18 years old

You cannot enter this study if you

Have had heart problems not related to your lymphoma in the 12 months before you start the study
Have HIV
Are pregnant or breastfeeding

Trial design

This study will recruit around 120 patients from centres around the world. Everyone in the study will have 2 PET scans, and give their permission for the research team to study a stored tissue sample of their lymphoma. The chemotherapy treatment you will be having is not part of the study.

You will have your first PET scan either before your first chemotherapy treatment, or within 2 weeks of starting treatment. You must not have food or sugary drink for 6 hours before the scans, as this could affect the results. You then have an injection into a vein of a radioactive drug (tracer) called FDG. The amount of radiation is very small and shouldn’t cause any side effects. An hour later you have your PET scan, which will take between 30 and 60 minutes.

You repeat the PET scan when you finish your course of chemotherapy.

The staff may give you a mild sedative tablet to relax the muscles in your neck. This will make the scan clearer. The sedative may make you a little sleepy, so you should ask someone to drive you home after the scan.

The researchers will also ask if they can study a small sample of the lymphoma tissue taken before your diagnosis. The cell samples and medical information from this study will be treated anonymously, so no one will be able to link your results to you.