A trial looking at enzastaurin to treat diffuse large B cell lymphoma (PRELUDE)

Cancer type:

Blood cancers
High grade lymphoma
Lymphoma
Non-Hodgkin lymphoma

Status:

Results

Phase:

Phase 3

This trial was for people with diffuse large B cell lymphoma who had a high risk of their cancer coming back after treatment.

More about this trial

Diffuse large B cell lymphoma (DLBCL) is a type of high grade non Hodgkin lymphoma. The standard treatment for DLBCL is R-CHOP 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 type of biological therapy. It blocks the signals that tell lymphoma cells to grow. Earlier research had shown that enzastaurin may help to slow or stop cancer growth.

Doctors thought that enzastaurin might help to keep lymphoma in remission Open a glossary item for longer. This is called maintenance treatment.

The people who took part in this trial were in remission following treatment with R-CHOP. This included people with stage 3 or 4 disease, and some people with stage 2 disease.  

The aims of this trial were to find out:

  • if enzastaurin works as a maintenance treatment for DLBCL
  • more about side effects and quality of life
  • more about how enzastaurin works in the body 

Summary of results

The researchers found that enzastaurin did not benefit people with diffuse large B cell lymphoma who had a high risk of their cancer coming back. It did not work as a maintenance treatment.

This was an international randomised trial. The people taking part were put into 2 groups by computer.

Neither they nor their doctor were able to decide which group they were in. And they were not told which group they were in. This is called a double blind trial Open a glossary item.

742 people took part.

  • 493 people had treatment with enzastaurin
  • 249 people had a dummy tablet (placebo) Open a glossary item

For every person in the placebo group, 2 people were in the enzastaurin group. So nearly twice as many people were in the group having enzastaurin. 

PRELUDE Trial Diagram

Everyone had enzastaurin or placebo tablets every day for up to 3 years. Or until their disease started to grow again, or they had to stop treatment because of severe side effects.  

After 4 years, the trial team looked at how many people had no signs of their lymphoma (were in remission):

  • 7 out of 10 people (70%) who had enzastaurin
  • Just over 7 out 10 people (71%) who had the placebo

The researchers concluded that there was no significant difference between the 2 groups. Those who had enzastaurin were not in remission for any longer compared to those people who had the placebo.

They also looked at the side effects people had in both groups and how severe these side effects were. To establish how severe a side effect is, doctors grade them from 1 (mild) to 4 (very serious).

The researchers found that people in both groups had mainly mild side effects.  Those people who had enzastaurin had more:

  • diarrhoea
  • changes to the colour of their wee and poo
  • changes to a test called a heart trace (ECG Open a glossary item)

The ECG changes in people did not generally cause symptoms and were harmless. People did not have to stop treatment as a result.

Changes to the colour of people’s wee and poo were not serious

Most people taking part (in both groups) had just under 3 years of treatment. The main reason why people stopped treatment early was that their lymphoma had come back (relapsed).   

We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

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

Dr Mayukh Das

Supported by

Eli Lilly and Company Limited
Experimental Cancer Medicine Centre (ECMC)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

1750

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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