>> trying to find out if a drug called bortezomib (Velcade) can help to stop diffuse large B cell lymphoma coming back after treatment. This trial is supported by Cancer Research UK.
Diffuse large B cell lymphoma (DLBCL) is one of the most common types of high grade non Hodgkin lymphoma. The.
We know from research that there are 2 distinct sub types of DLBCL, which researchers call GCB and ABC. The type you have depends on the activity of genes in your lymphoma cells. As part of this trial, researchers will use a technique called molecular profiling to look at the genes in each patient’s lymphoma cells and see which type they have. They will then compare how people with each sub type get on.
The aims of the trial are to
You can enter this trial if you
You cannot enter this trial if you
This is a phase 3 trial. It will recruit more than 900 people.
Everybody taking part will start by having R-CHOP (chemotherapy with a monoclonal antibody). You have 4 drugs through a drip into a vein on the first day. You also take steroid tablets called prednisolone on that day and the following 4 days. Then you have no treatment for the next 16 days. This 3 week period makes up 1 cycle of treatment.
During this time (and with your permission), the trial team will send a sample of your lymphoma cells to a specialist laboratory. Tests in the laboratory will show if you have type GCB or type ABC diffuse large B cell lymphoma.
For some people, the laboratory tests will not be clear. If this happens you will still take part in the trial, but will carry on having standard treatment with R-CHOP.
If the laboratory tests do show your lymphoma sub type, you will be put into 1 of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. This is called randomisation.
People in one group have 5 more cycles of R-CHOP. People in the other group have 5 more cycles of R-CHOP and bortezomib. You have bortezomib on days 1 and 8 of each treatment cycle.
The trial team will ask you to fill out a questionnaire a number of times during and after your treatment. The questionnaire will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.
You will see the trial team and have some tests before you start treatment. The tests include
You may have a heart ultrasound (
You may also need to have a lumbar puncture.
Depending on which group you are in, you go to hospital once or twice in each 3 week treatment cycle. You have regular blood tests.
When you finish treatment, you see the trial team again a couple of weeks later. If you had lymphoma cells in your bone marrow at the beginning of the trial, you may need to have another bone marrow test. You have a CT scan a month after finishing treatment and another a year later.
The trial team will continue to see you for 5 years. You have follow up appointments every 3 months for the first year, then every 6 months.
The side effects of CHOP chemotherapy include
The side effects of rituximab include
The common side effects of bortezomib include
You must not drink green tea or grapefruit juice during the trial as these can interact with bortezomib.
We have more information about R-CHOP and bortezomib in our cancer drugs section.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Peter Johnson
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Janssen-Cilag
NIHR Clinical Research Network: Cancer
University Hospital Southampton NHS Foundation Trust
University of Southampton
This is Cancer Research UK trial number CRUKE/10/024.
Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.