"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 treatment for people with newly diagnosed chronic lymphocytic leukaemia (ADMIRE)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Doctors usually treat CLL with 2 chemotherapy drugs called fludarabine and cyclophosphamide. Sometimes they give chemotherapy in combination with a newer type of biological therapy called rituximab. Doctors call this combination FCR.
Earlier trials showed that adding a chemotherapy drug called mitoxantrone to FCR is a useful treatment for CLL. Doctors call this combination FCM-R. The doctors in this trial think that this combination will help to lower the number of leukaemia cells that can be left behind after treatment. Doctors call these remaining cancer cells ‘minimum residual disease’ or MRD. An undetectable MRD level means the leukaemia is less likely to come back.
The aims of this trial are to find out
- If FCM-R is better than FCR for people with newly diagnosed CLL
- More about the side effects
Who can enter
You can enter this trial if you
- Have B cell chronic lymphocytic leukaemia (B cell CLL) including a type called small lymphocytic (SLL) and you have not had treatment
- Have a high number of lymphocytes, low numbers of platelets and a low red blood cell count – you can check this with your doctor
- Have enlarged lymph nodes,
liveror spleen– you can check this with your doctor
- Have stage B or C CLL or you have stage A that has worsened and you need treatment
- Have at least one of the following symptoms– significant weight loss, tiredness (fatigue) that makes it difficult to go about your usual daily activities, high fevers for at least 2 weeks with no signs of an infection or night sweats for more than 2 months with no signs of an infection
- Are well enough to take part (performance status 0, 1 or 2)
- Are willing to use reliable contraception if there is any chance that you or your partner could become pregnant
- Have satisfactory blood and urine test results
- Are at least 18 years old
You cannot enter this trial if you
- Have already had treatment for B cell CLL
- Have B cell CLL that has spread to your brain or spinal cord (central nervous system)
- Have ‘mantle cell’ lymphoma
- Have a very low number of neutrophils and platelets or you have regular blood transfusions unless this is because your CLL is in the
- Have significant heart problems or angina that is not controlled with medication
- Have significant bleeding problems
- Have kidney problems
- Have an infection that won’t get better
- Have had a sudden, severe allergic reaction (‘anaphylactic shock’) after antibody treatment
- Have had any other cancer apart from basal cell skin cancer
- Are pregnant or breastfeeding
- Have Hepatitis B, Hepatitis C or HIV
218 people will take part in this phase 2 trial. It is a
Each 4 week period is one cycle of treatment. You take fludarabine and cyclophosphamide tablets everyday for the first 5 days of each treatment cycle. You have rituximab as a drip into a vein on the first day of each treatment cycle. If you are in group 2 you also have mitoxantrone as a drip into a vein on the first day of each treatment cycle. Everyone will have up to 6 cycles of treatment. The treatment will take up to 6 months in total.
You will have some tests after the third cycle of treatment. If the tests show treatment is working well, you will continue to have 3 more treatment cycles. If the treatment is not helping you the doctor will probably decide to stop treatment and will discuss further treatment options with you.
You will see the doctors and have some tests before you start treatment. The tests include
- Physical examination
Heart trace (ECG)
- Bone marrow test
- CT scan of your chest, stomach and pelvic area
- Chest X-ray
- Blood tests
- Urine tests
3 months after you finish treatment you will have some of these tests again, to see how well the treatment has worked. You will also see the trial doctor every 6 months for up to 2 years and then yearly after that.
The most common side effects of chemotherapy include
- A drop in blood cells causing an increased risk of infection, shortness of breath, tiredness and bleeding or bruising problems
- Tiredness (fatigue)
- Hair loss
Rituximab does not seem to cause serious side effects. But when you first have rituximab you may have side effects such as
- Fever and chills
- Feeling sick
- Itchy rash
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Peter Hilmen
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
The Leeds Teaching Hospitals NHS Trust
University of Leeds
This is Cancer Research UK trial number CRUKE/09/016.