Summary of results
This trial showed that the combination of ibrutinib and rituximab could be a useful treatment for mantle cell lymphoma.
Results
A total of 397 people joined this trial. They were put into 1 of 2 treatment groups at random:
half had ibrutinib and rituximab (IR)
half had rituximab and chemotherapy (R-chemo)
People had one of these treatments for about 6 months. And then had rituximab every 2 months for up to 2 years. This is called maintenance treatment.
The doctors decided which chemotherapy treatment was best for those in the R-chemo group. Of 198 people in this group:
53 people had R-CHOP
145 people had bendamustine and rituximab (BR)
The research team looked at the results in 2024. First they looked at how long it was until half the people taking part had died or their lymphoma had got worse. And half the people were living and their lymphoma had not got worse. This is called median progression free survival.
They found it was:
5 years and 5 months (65 months) for those who had IR
3 years and 6 months (42 months) for those who had R-chemo
They also looked at how many people in each group were living 5 years after they joined the trial. They found this was similar in the two groups:
just under 6 out of 10 people (58%) who had IR
more than 5 out of 10 people (55%) who had R-chemo
When they looked in more detail, they found both of these results were a bit higher for those who had BR compared to those who had R-CHOP.
Side effects
The team looked at the side effects people had up to the end of their maintenance rituximab treatment.
Some people taking part had side effects that were mild. But some people in each group had more severe side effects.
The research team looked at how many people in each group had more severe side effects that affected their blood system. This could be side effects such as a drop in blood cells.
This was:
less than 2 out of 10 people (17%) who had IR
5 out of 10 people (50%) who had R-CHOP
more than 3 out of 10 people (34%) who had BR
Some people also had other more severe side effects. We don’t have any more details about what these were.
The percentage of people who had other side effects were:
just over 6 out of 10 people (61%) who had IR
just over 5 out of 10 people (52%) who had R-CHOP
just over 5 out of 10 people (52%) who had BR
One of the reasons this is higher in the IR group was because some people in that group had treatment for longer.
Quality of life
The people taking part completed questionnaires before, during and after treatment. The questionnaires asked people about various aspects of their physical and mental health.
The results showed that, half way through treatment, the people having IR had a higher quality of life score than those having R-chemo.
Conclusion
The trial team concluded that IR can help stop mantle cell lymphoma growing for longer than R-chemo. It also caused fewer side effects and people had a better quality of life part way through treatment.
The team suggest IR should be considered as an option for for older people with mantle cell lymphoma who haven’t had treatment yet.
