A trial to see if enzastaurin can help stop diffuse large B cell lymphoma coming back after treatment (PRELUDE)

Please note this trial is no longer recruiting patients.

This trial is looking at a new drug called enzastaurin for people with diffuse large B cell lymphoma (DLBCL) who have a high risk of their cancer coming back after RCHOP chemotherapy.

Diffuse large B cell lymphoma (DLBCL) is a type of high grade non Hodgkin’s lymphoma. The standard treatment for DLBCL is RCHOP chemotherapy. This is a successful treatment for many people. But people with ‘high risk’ lymphoma have an increased chance of it coming back or continuing to grow despite treatment.

Enzastaurin is a biological therapy. Earlier research has shown that enzastaurin may help to slow or stop cancer growth as it blocks the signals that tell lymphoma cells to grow. Doctors think that enzastaurin may help to keep lymphoma in remission for longer. This is called ‘maintenance treatment’.

This trial will recruit people who have completed RCHOP treatment within the last 12 weeks and are in remission.

The aims of this trial are to find out

If enzastaurin as a maintenance treatment after RCHOP stops DLBCL coming back
More about side effects and quality of life
More about how enzastaurin works in the body

Recruitment

Start 01/10/2007

End 31/03/2010

Phase

Phase 3

Who can enter

You can enter this trial if you

Have had a diagnosis of diffuse large B cell lymphoma
Had stage 3 or 4 disease, or had stage 2 disease that measured more than 10cm across, when you were first diagnosed
Have completed 6 to 8 cycles of RCHOP chemotherapy within the last 12 weeks and there is no sign of your cancer after treatment
Have a high risk of your lymphoma coming back - your doctor can tell you more about this
Are well enough for treatment (performance status 0, 1 or 2)
Have satisfactory blood test results
Are at least 18 years old
Are willing to use reliable contraception during the trial and for 3 months after you finish treatment if there is any chance that you or your partner could become pregnant

You cannot enter this trial if

You have had a bone marrow or stem cell transplant in the past
You are currently having any other systemic treatment for lymphoma
You have had radiotherapy to more than one area for the treatment of lymphoma or are still having side effects from radiotherapy treatment
Your lymphoma has spread to your brain or spinal cord (central nervous system) unless it has been successfully treated and you have not taken steroids in the last 4 weeks
You have ever had a condition called ‘indolent lymphoma’
You have had experimental treatment as part of a clinical trial in the last 30 days
You have any other cancer unless it has been in complete remission for at least 5 years or it was non melanoma skin cancer that was successfully treated
You are having treatment with drugs to control fits (seizures) such as carbamazepine, phenobarbital or phenytoin
You have had a heart attack in the last 6 months or have a serious heart problem
You are unable to swallow tablets
You are known to have HIV
You are pregnant or breastfeeding

Trial design

This international phase 3 trial will recruit 709 people. It is a randomised trial. The people taking part are put into 2 different groups by computer. Neither you nor your doctor will be able to decide which group you are in, or will be told which group you are in. This is called a double blind trial.

If you are in group 1, you will have enzastaurin. If you are in group 2, you will have a dummy tablet (placebo).

You will take either enzastaurin or placebo as tablets everyday. You will have treatment for up to 3 years.

During treatment you will have regular scans to see if your DLBCL has come back. If your DLBCL does come back, the trial doctor will stop treatment. They will then discuss other treatment options with you.

The researchers will look at a sample of the biopsy you had when you were first diagnosed. You will also have some extra blood samples. Doctors will use these to find out more about the genes and proteins in cancer cells. This will help doctors understand why people respond differently to treatment, and which patients may benefit from enzastaurin in the future.

Hospital visits

Before you start treatment, your trial doctor will examine you and you will have some tests. The tests include

Blood tests
CT scan or MRI scan of your chest, stomach and lower abdomen (pelvic area)
Heart trace (ECG)

You may also have a bone marrow test.

You will go to the hospital for blood tests and to see the doctor every month for the first 6 months and then every 3 months until you finish treatment.

During the trial you will have a CT scan or MRI scan every 2 months during the first 6 months of treatment, and then every 3 months after that. You will have an ECG in the first and second month of treatment, then once a year for the next 3 years.

You will be asked to fill out 1 to 2 questionnaires before you start treatment and at most hospital visits. The questionnaire will ask about how you have been feeling. This is called a quality of life questionnaire.

When you finish treatment you will see the doctor at the hospital for follow up appointments about every 6 months.

Side effects

All treatments have side effects. Enzastaurin is a new drug and there may be some side effects that doctors don’t know about yet. Looking at research done so far, doctors think the side effects may include