Aim of the trial:
Why is the trial important?
Conditioning therapy is given before a stem cell transplant to prepare your body for the process. It normally consists of chemotherapy and sometimes radiotherapy as well. It removes any abnormal cells from your blood and creates space in your bone marrow for the donated stem cells to develop and multiply.
Although conditioning therapy is an essential part of the transplant journey, it can cause a variety of side effects including sickness, weight loss, fatigue and pain. These side effects vary depending on the type of conditioning therapy used. If patients are not healthy enough to cope with these side effects, they might be given reduced intensity conditioning (RIC) therapy. This generally reduces the number of side effects but can increase the chance of relapse and other complications occurring.
In early studies, the new treatment combination being tested here appears to have fewer side effects than the current NHS standard treatment. It now needs to be tested on more patients with ALL to confirm this finding and measure the effect it could have on the rate of relapse.
Who can take part?
Patients between the ages of 40 and 70 with ALL who need an allogenic stem cell transplant and are currently in complete remission.
What will happen to me?
Every patient on the trial will be given one of two types of conditioning treatment before their transplant. Half the patients will receive the current standard NHS treatment. This consists of two chemotherapy drugs called ‘fludarabine’ and ‘melphalan’ and an antibody that targets white blood cells called ‘Alemtuzumab’ (also known as ‘Campath’).
The second group will be given a new combination of treatments – Alemtuzumab, a chemotherapy drug called ‘cyclophosphamide’, and radiotherapy of the whole body.
Throughout the trial, you will be asked to undergo various check-ups and answer questionnaires that will be used to assess how effective the treatment is.
How will we know if the trial is successful?
The main objective of the trial is to see if fewer patients treated with the new combination experience relapse in the two years after transplant.
The study will also look at how each treatment affects patient wellbeing during recovery. This will be done by recording how many patients develop side effects like GvHD and infections, how often they need hospital treatment and other quality of life measurements.
If the new treatment combination is shown to be better at preventing relapse and/or improve quality of life, it could become the standard of care for all patients with ALL in the future.
Stage: Phase 2
Study lead: Professor David Marks, Bristol BMT Unit
Recruitment: 247 patients by September 2022
Study length: Seven years from Sept 2018
Information published: 03/09/20
Next review due: 03/09/23