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

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 Open a glossary item)
  • CT scan
  • Tissue sample (biopsy Open a glossary item) 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

Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor J A Radford

Supported by

Experimental Cancer Medicine Centre (ECMC)
Novartis

Freephone 0808 800 4040

Last review date

CRUK internal database number:

Oracle 9834

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Wendy took part in a new trial studying the possible side effect of hearing loss

A picture of Wendy

"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”

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