Please note this summary is about the results of those people who had induction therapy with alemtuzumab, dexamethasone and lenalidomide (CamDexRev).
A smaller number of people were recruited to this part of the trial than expected. So the trial team were not able to come to any firm conclusions. But they thought that this combination of drugs was a treatment that worked and was safe.
Those people who took part in this trial after September, 2012 had induction treatment with ofatumumab (Arzerra), dexamethasone and lenalidomide.
We hope to include the results for this group of people when they become available.
Induction therapy
- 6 months of induction therapy
- stem cell or bone marrow transplant for those who were suitable
- randomisation into maintenance treatment for people whose induction treatment had gone well, but were not suitable for a transplant
Sixteen people had induction therapy with:
Of these 16 people, 10 people completed 6 months of induction therapy. Other people didn’t finish their induction therapy for various reasons. For example, the side effects were too severe, or their leukaemia got worse (
relapsed 
).
Following induction therapy, the researchers looked at how well treatment had worked. Out of the 10 people the leukaemia:
- was well controlled in 8 people (partial remission)
- was very well controlled in 2 people (complete remission)
Three of the 10 people then had a
stem cell transplant. They stopped taking part in this trial before they had their transplant.
Maintenance therapy
The trial doctors then discussed maintenance therapy using lenalidomide with the other 7 patients.
This part of the trial was
randomised. 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.
Out of the 5 people who agreed to take part in the lenalidomide randomisation:
- 3 people had lenalidomide capsules every day
- 2 people had no further treatment
Those who had lenalidomide continued treatment for as long as it was controlling their leukaemia.
Out of the 3 people who have maintenance therapy using lenalidomide:
- 1 person’s leukaemia was still under control (in remission) after 2 years
- 1 person stopped lenalidomide after 2 months because their leukaemia started to grow again (relapse)
- 1 person stopped lenalidomide after 3 months to have a transplant
The researchers looked at the time it took for the leukaemia to come back (relapse) in all those taking part. They were able to record this in 15 of the 16 patients. On average it was just under 2 ½ years.
The most common side effects reported with induction therapy included:
- a drop in blood cells causing an increased risk of infection such as chest infection
- a drop in blood cells causing an increased risk of tiredness and breathlessness (anaemia
)
- a drop in blood cells causing an increased risk of bleeding problems
- build up of fluid in the legs (oedema)
The trial team continued to see people at regular appointments for just under 4 years. They asked people about their side effects. 14 of the 16 patients had at least one severe side effects during this time.