"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial looking at bortezomib and CHOP chemotherapy for relapsed mantle cell lymphoma
This trial was for mantle cell lymphoma that has not responded to treatment or had come back. Mantle cell lymphoma is a rare type of non Hodgkin Lymphoma. This trial was supported by Cancer Research UK.
More about this trial
Doctors usually treat mantle cell lymphoma with chemotherapy. But sometimes this type of lymphoma does not respond very well to chemotherapy or it comes back after treatment (relapsed). Doctors wanted to find out if bortezomib could improve treatment for this type of cancer.
Bortezomib is a type of biological therapy called a proteasome inhibitor. Proteasomes are substances found in all cells that help break down proteins. Bortezomib interferes with the way they work, leading to a build up of proteins in the cells. This causes cells to die. Research has shown that cancer cells are more sensitive to bortezomib than normal cells.
In this trial, some people had chemotherapy and some people had chemotherapy and bortezomib.
The aims of this trial were:
- to find out if chemotherapy and bortezomib worked better than chemotherapy alone for mantle cell lymphoma
- to learn more about the side effects
Summary of results
The trial team found that adding bortezomib to chemotherapy improved the treatment for people with mantle cell lymphoma.
The original aim of the trial was for 66 people to take part. The trial team found that people who had bortezomib and chemotherapy were doing better than those who had chemotherapy alone. So the trial closed early.
This phase 3 trial recruited 46 people. This means the people taking part were put into 1 of 2 treatment groups by a computer. Neither they nor their doctor chose which group they were in.
- 23 people had CHOP chemotherapy
- 23 people had CHOP and bortezomib
CHOP chemotherapy includes the following drugs:
The trial team were able to measure the cancer in 41 of the patients. They looked at how many people had no signs of lymphoma. This is called a
- 4 out of the 19 people (about 22%) who had CHOP alone
- 8 out of 22 people (about 35%) who had CHOP and bortezomib
The researchers also looked at whose lymphoma got a bit better. This is called a
- 4 out of the 19 people (about 26%) who had CHOP alone
- 11 out of 22 people (about 48%) who had CHOP and bortezomib
The researchers looked at the time it took for the cancer to start growing again. On average it was
- just over 8 months for people who had CHOP alone
- 16 ½ months for people who had CHOP and bortezomib
The researchers concluded that these results were not significant because they could have happened by chance. One reason for this was because more people who had CHOP on its own withdrew early from the trial.
The trial team looked at how long people lived for. They found that on average:
- people having CHOP lived for just under 1 year
- people having CHOP and bortezomib lived for just under 3 years
The researchers decided these results were significant and that no more people should be recruited to the CHOP alone treatment group. So the trial closed early.
The most common side effects reported in both groups were:
- a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- tiredness (fatigue)
More people who had CHOP and bortezomib developed
- Numbness and tingling in their hands and feet (peripheral neuropathy)
Infections in both groups were not serious and treated successfully. Numbness and tingling were also mild and often only lasted for a short period of time.
The researchers concluded that generally people who had chemotherapy and bortezomib coped well with the increase in side effects.
The researchers recognise that adding another drug to chemotherapy, called rituximab, has also shown promise in trials. Rituximab is a type of biological therapy called a
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
Professor Simon Rule
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Johnson and Johnson Pharmaceutical R+D
NIHR Clinical Research Network: Cancer
University Hospitals Plymouth NHS Trust
This is Cancer Research UK trial number CRUKE/07/056.