
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at different doses of ofatumumab in combination with chemotherapy for people with chronic lymphocytic leukaemia (CLL).
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
You may be able to enter this trial if you
You cannot enter this trial if you
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.
You see the doctors and have some tests before you start treatment. The tests include
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.
The most common side effects of fludarabine are
The most common side effects of cyclophosphamide are
The most common side effects of bendamustine are
The most common side effects of ofatumumab are
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.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Peter Hillmen
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
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
“I think it’s really important that people keep signing up to these type of trials to push research forward.”