A trial comparing different doses of ofatumumab in chronic lymphocytic leukaemia (COSMIC)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This trial is looking at different doses of ofatumumab in combination with chemotherapy for people with chronic lymphocytic leukaemia (CLL).
More about this trial
Doctors usually treat chronic lymphocytic leukaemia (CLL) with chemotherapy. But sometimes the cancer starts to grow again. When this happens it is often more difficult to treat.
In this trial, doctors want to use bendamustine or a combination of fludarabine and cyclophosphamide, with either the standard dose or a higher dose of ofatumumab.
Ofatumumab (pronounced off-ah-too-moo-mab) is a type of biological therapy called a monoclonal antibody. These can seek out cancer cells by looking for particular proteins.
The aims of this trial are to find out
- The best dose of ofatumumab to use in combination with chemotherapy
- More about the side effects
Who can enter
You may be able to enter this trial if you
- Have chronic lymphocytic leukaemia (CLL) that has come back following treatment
- Have had at least 1 type of chemotherapy in the past
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Are willing to use reliable contraception during treatment and for 12 months afterwards if there is any chance that you or your partner could become pregnant
- Are at least 18 years old
You cannot enter this trial if you
- Are not well enough to have fludarabine chemotherapy or you have had it in the past and it did not help you - you can ask your doctor about this
- Have CLL that has come back (relapsed) within 12 months of having treatment with fludarabine, cyclophosphamide and rituximab (FCR)
- Have a change to a gene called 17p the doctor will test your
bone marrow 
for this - Have had ofatumumab before
- Have an infection that cannot be controlled or any other condition that could make it unsafe for you to take part in this trial
- Have taken part in a drug trial in the last month
- Have had another type of cancer, apart from
carcinoma in situ or non melanoma skin cancer or any other cancer that was successfully treated at least 2 years ago - Have had a monoclonal antibody that targets the CD20 protein, such as rituximab, in the last 3 months
- Have had a monoclonal antibody called alemtuzumab in the last 3 months
- Have certain heart problems
- Are HIV, hepatitis B or hepatitis C positive
- Are pregnant or breastfeeding
- Have blood test results that could make it unsafe to take part in the trial
Trial design
This trial will recruit 82 people from around the UK.
Everybody taking part has either bendamustine or a combination of fludarabine and cyclophosphamide to begin with. Your doctor will decide which of these treatments is best for you.
If you have bendamustine, you have it through a drip into a vein on the first two days of every 4 weeks. If you have fludarabine and cyclophosphamide, you have it daily for 5 days every 4 weeks. You may have these through a drip into a vein or as tablets. Each 4 week period is called a cycle of treatment.
Everybody taking part then has ofatumumab through a drip into a vein. This part of the trial is randomised. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. Everybody has treatment for up to 24 weeks (6 cycles).
People in group 1 have the standard dose of ofatumumab. You have this twice in your first cycle of treatment, and then once every 4 weeks after that.
People in group 2 have the higher dose of ofatumumab. You have it once a week for 8 weeks, and then once every 4 weeks after that.
If you agree to take part in this study, the researchers will ask for extra samples of blood and spit (saliva). If you don’t want to give extra samples for this trial you don’t have to. You can still take part in the trial.
Hospital visits
You see the doctors and have some tests before you start treatment. The tests include
- Blood tests
- Physical examination
- Heart trace (
ECG ) - CT scan
- Bone marrow test
- Chest X-ray
You see the doctors and have blood tests frequently while you are having treatment and again when you stop treatment.
When you stop treatment, you see the trial doctor 3 months later and have a physical examination, blood tests, a bone marrow test and a CT scan.
You then see the doctor every 6 months up to 2 years, then once a year. At these visits you will have a physical examination and blood tests. You may also need to have a CT scan and your doctor will discuss this with you.
Side effects
The most common side effects of fludarabine are
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- A cough
- Diarrhoea
- Feeling or being sick
- Fever
- Tiredness (fatigue)
The most common side effects of cyclophosphamide are
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Hair loss
- Sore mouth
- Changes in skin colour
- Changes in taste
- Feeling or being sick
The most common side effects of bendamustine are
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Feeling or being sick
- A rash
- Tiredness (fatigue)
- Sore mouth
The most common side effects of ofatumumab are
- A cough
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- A rash
- Fever and chills
Some people have an allergic reaction to ofatumumab. You will have some medication before each treatment to help stop this happening. And your nurse will keep a close eye on you while you are having treatment.
There is more information about bendamustine, fludarabine, cyclophosphamide and ofatumumab in our cancer drugs section.
Recruitment start:
Recruitment end:
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.
Chief Investigator
Professor Peter Hillmen
Supported by
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
Leeds Institute of Clinical Trials Research (University of Leeds)
Leeds Teaching Hospitals NHS Trust
Novartis
NIHR Clinical Research Network: Cancer
Other information
This is Cancer Research UK trial number CRUKE/11/018.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
