A trial of rituximab as an injection under the skin for diffuse large B cell lymphoma (MabEase)

Cancer type:

Blood cancers
High grade lymphoma
Lymphoma
Non-Hodgkin lymphoma

Status:

Results

Phase:

Phase 3

This trial compared different ways of having rituximab alongside chemotherapy as the first treatment for diffuse large B cell lymphoma.

It was open for people to join between 2012 and 2016, and the research team published the results in 2017.

More about this trial

Diffuse large B cell lymphoma (DLBCL) is a type of non Hodgkin lymphoma

Doctors often treat this type of lymphoma with R-CHOP. This is rituximab and a combination of chemotherapy drugs called CHOP. 

Rituximab (Mabthera) is a type of immunotherapy called a monoclonal antibody. It helps the immune system recognise and kill lymphoma cells.

When this trial was done, the standard treatment for DLBCL was rituximab through a drip into a vein (intravenous treatment). In this trial, researchers compared this with rituximab as an injection just under the skin (a subcutaneous injection).

The aims of this trial were to find out if rituximab injections under the skin:

  • worked as well as rituximab into a vein
  • caused fewer side effects
  • improved quality of life
     

Summary of results

The research team found that there wasn’t much difference in how well the two ways of having rituximab worked for diffuse large B cell lymphoma. And 
patients said having injections into the skin was better in some ways.

About this trial
This trial was for people with diffuse large B cell lymphoma (DLBCL) who hadn’t had any treatment yet.

Everyone taking part had CHOP chemotherapy. This is made up of the chemotherapy drugs cyclophosphamide, doxorubicin and vincristine, and the steroid prednisolone. 

Everyone taking part also had rituximab. Some people had it through a drip into a vein (intravenous). And some people had it as an injection under the skin (subcutaneous).

Results
572 people had treatment as part of this trial. They were put into 1 of 2 treatment groups at random. They all had CHOP chemotherapy, and:

  • 378 had rituximab as an injection under the skin (subcutaneous)
  • 194 had rituximab through a drip into a vein (intravenous)

The research team looked at how well the treatment worked. They found that the lymphoma went away or got a bit better in:

  • just over 8 out of 10 people (82%) who had subcutaneous rituximab
  • just under 8 out of 10 people (78%) who had intravenous rituximab

They then looked at how many people’s lymphoma had not started to grow again after 3 years. It was more than 7 out of 10 (70%) in each group:

  • 72% of those who’d had subcutaneous rituximab
  • 79% of those who’d has intravenous rituximab

And when they looked at how many people were living, they found there wasn’t much difference between the 2 groups. It was more than 8 out of 10 (80%) in each group.

How long treatment took
People who had injections under the skin were at the hospital for less time than those who had the infusion into a vein.

The research team looked at how many people were at the hospital for 4 hours or more when they had their second dose of rituximab. They found it was:

  • less than 2 out of 10 people (17%) who had subcutaneous rituximab
  • more than 6 out of 10 people (61%) who had intravenous rituximab

Quality of life
The researchers asked the people who took part how having treatment affected their quality of life. They asked about things such as:

  • how much it affected their day to day life
  • how convenient it was
  • whether they were satisfied with the treatment
  • how much it affected them physically
  • how much it affected them psychologically 

There wasn’t much difference between the two groups for most of these issues. But they were all a bit better for people who had rituximab as an injection under the skin (subcutaneous rituximab). 

The biggest difference was the convenience and impact on daily life for people who had subcutaneous rituximab.

Side effects
About 9 out of 10 people (90%) in each group had at least one side effect. Many were mild or short lived. But more than 5 out of 10 people in each group had more severe side effects:

  • 58% of those who had subcutaneous rituximab
  • 54% of those who had intravenous rituximab

The most common side effects were a drop in red and white blood cells, extreme tiredness, feeling sick and hair loss.

We have more information about the side effects of R-CHOP in our Cancer Drugs section.

Conclusion
The trial team concluded that rituximab as an injection under the skin worked as well as a rituximab into the vein, and didn’t cause any more side effects. They also found people generally found treatment easier.

The team suggest that subcutaneous rituximab should be considered as a treatment option for diffuse large B cell lymphoma.

Where this information comes from    
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 Andrew Hodson

Supported by

NIHR Clinical Research Network: Cancer
Roche

Freephone 0808 800 4040

Last review date

CRUK internal database number:

10669

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

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