"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial of rituximab as an injection under the skin for diffuse large B cell lymphoma (MabEase)
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
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).
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.
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.
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 (
How to join a clinical trial
Dr Andrew Hodson
NIHR Clinical Research Network: Cancer