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.

Cancer type:

High grade lymphoma

Lymphoma

Non-Hodgkin lymphoma

Status:

Closed

Phase:

Phase 1

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.

Doctors can treat DLBCL with chemotherapy, radiotherapy or both. But sometimes the lymphoma starts to grow again. When this happens it is often more difficult to treat.

AEB071 is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.

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 anthracycline chemotherapy 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

Trial design

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 biopsy Open a glossary item . Doctors need this to test for the CD79 gene.

Hospital visits

You will see the doctors and have some tests before you start treatment. The tests include

Blood tests
Physical examination
Urine tests
Heart trace (ECG )
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.

Side effects

As AEB071 is a new drug, there may be some side effects we don’t know about yet. The possible side effects that researchers already know about include