"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial looking at AEB071 for people with non Hodgkin lymphoma
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a new drug called AEB071 for people with diffuse large B cell lymphoma (DLBCL) that has come back after treatment.
The aims of this trial are to find out
- The best dose of AEB071 to use
- What the side effects are
- What happens to AEB071 inside the body
- How well it works for DLBCL
Your lymphoma will be tested to find out if it has a change to the CD79 gene. You will not be able to take part in this trial if your lymphoma cells do not have this change.
Who can enter
You may be able to enter this trial if you
- Have diffuse large B cell lymphoma with a change to the CD79 gene
- Have had slow growing lymphoma that changed to DLBCL
- Have been treated with
anthracyclinechemotherapy and a bone marrow or stem cell transplant and your lymphoma has come back (your doctor can tell you this)
- Have not had a transplant but have had chemotherapy such as R-CHOP or R-EPOCH (your doctor can tell you this)
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Have satisfactory blood results
- Are willing to use reliable contraception during treatment and for 2 days afterwards if there is any chance that you or your partner could become pregnant
- Are at least 18 years old
You cannot enter this trial if you
- Are taking certain medications that can affect how the body absorbs AEB071
- Have certain heart problems
- Have had any other cancer, apart from carcinoma in situ of the cervix or non melanoma skin cancer that was successfully treated at least 3 years ago
- Have problems absorbing food
- Have had a severe infection in the last 2 weeks and it is still causing you problems
- Are HIV positive
- Are hepatitis B or hepatitis C positive and not having treatment
- Have had chemotherapy in the last 2 weeks or biological therapy in the last 4 weeks and still have side effects
- Have had radiotherapy to the area your doctors want to measure for this trial
- Have had major surgery in the last 4 weeks
- Are pregnant or breastfeeding
There are 2 parts to this phase 1 trial. Everybody taking part will have AEB071 daily.
In the first part of the trial, the researchers are trying to work out the best dose of AEB071 to give. The first few patients will have a low dose. If they don’t have any serious side effects, the next few patients will have a higher dose. And so on, until the researchers find the highest dose that can be given safely. This is called a dose escalation study.
Once they’ve found the highest safe dose, the researchers want to learn more about how AEB071 works. You continue to take the tablets daily until your lymphoma starts to grow again or you do not want to continue. The dose will depend on when you joined the trial.
If you agree to take part in this study, the researchers will ask for a sample of tissue taken when you had surgery to diagnose your cancer. If this is not available you will need to have a
You will see the doctors and have some tests before you start treatment. The tests include
- Blood tests
- Physical examination
- Urine tests
- Heart trace (
- CT scan
- Tissue sample (
biopsy) if no previous samples are available
You will see the doctors and have heart, blood and urine tests frequently while you are taking AEB071.
You have CT scans every 8 weeks for 6 months then every 3 months until your cancer starts to grow again.
You see the doctors 30 days after you stop the AEB071. This is the last trial visit.
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.
Professor J A Radford
Experimental Cancer Medicine Centre (ECMC)