"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 ofatumumab for people with chronic lymphocytic leukaemia who cannot have more intensive treatment (RIAltO)
This trial is looking at using ofatumumab with bendamustine or chlorambucil chemotherapy for people with chronic lymphocytic leukaemia who cannot have intensive treatment. This trial is supported by Cancer Research UK.
More about this trial
Doctors often treat chronic lymphocytic leukaemia (CLL) with fludarabine, cyclophosphamide and a biological therapy called rituximab. This combination of drugs is called FCR. FCR is intensive treatment and works well for people who are reasonably fit. For people who may not be able to cope with the side effects of FCR your doctor may suggest chlorambucil or bendamustine.
The aims of this trial is to compare ofatumumab and chlorambucil with ofatumumab and bendamustine to find out which is the best combination for people with CLL who are not fit enough for more intensive treatment.
Who can enter
- Your doctors can see your
bone marrowis getting worse because your numbers of red blood cellsand platelets are dropping
- You have a very enlarged spleen that may be causing pain or discomfort
- You have very swollen lymph nodes that may be causing pain or discomfort
- The number of white blood cells called
lymphocytesin your blood has doubled in the last 6 months
- You have not been treated for CLL - if you have had radiotherapy to an area of your body, such as your spleen or lymph nodes, you may be able to take part
- Your doctor thinks you are not fit enough to have the full dose of fludarabine, cyclophosphamide and rituximab (FCR)
- Your doctor thinks you are well enough to have chlorambucil
- Your other blood test results are satisfactory
- You are willing to use reliable contraception during treatment and for a year afterwards if there is any chance you or your partner could become pregnant
You cannot enter this trial if you
- Have CLL that has spread to your brain or spinal cord
- Have CLL that has changed to Richter’s syndrome
- Have a condition called
autoimmune haemolytic anaemiaor thrombocytopeniathat is not controlled
- Have had a
bone marrow or stem cell transplant from a donor
- Have had an organ transplant
- Are taking a drug (steroid) that damps down your
immune systemunless it is a small dose
- Have had a
monoclonal antibodyin the last 3 months
- Have a serious heart problem or have had a heart attack in the last 6 months
- Have had major surgery in the last month
- Are in bed or a chair all the time and need complete help (performance status 4)
- Have an infection
- Have had a vaccination for yellow fever in the last month
- Are allergic to ofatumumab, bendamustine, chlorambucil or any of their ingredients
- Have had treatment as part of another clinical trial in the last month
- Have had another cancer in the last 3 years apart from non melanoma skin cancer or
carcinoma in situthat has been successfully treated
- Have another serious condition that could affect you taking part in this trial
- Are pregnant or breastfeeding
This is a phase 3 trial. It will recruit 670 people in the UK. It is a randomised trial. You will be put into 1 of 2 treatment groups. The treatments that the people in each of the groups will have are
- Ofatumumab and chlorambucil
- Ofatumumab and bendamustine
You have treatment in this trial repeated every 4 weeks. Each 4 week period is called a cycle of treatment.
You have ofatumumab and bendamustine as a drip into a vein. You can have up to 6 cycles of bendamustine.
Chlorambucil is a tablet. You take it for the first week of each cycle. You can have up to 12 cycles of chlorambucil.
The researchers will ask you to fill in a couple of questionnaires every 3 months while you are in the trial. They will ask how you have been and about any side effects you have had. This is called a quality of life study.
They will also ask your permission to take some extra blood samples, saliva samples, and to keep samples taken when you have a bone marrow test. These samples will be stored safely and may be used in the future for research purposes only. Studying these samples may help researchers learn more about leukaemia.
You don’t have to agree to these extra samples if you don’t want to. You can still take part in the main trial.
You see the doctor and have some tests before taking part in this trial. These tests include
- A physical examination
- Blood tests
- A test to see how quickly you can get out of a chair, walk a few steps and sit down again
- CT scan
- Bone marrow test
During treatment you see the doctor for a blood test every 4 weeks, before each cycle.
You see the doctor 3 months after finishing treatment for the same tests you had at the start apart from the bone marrow test. You then see the doctor every 3 months for a maximum of 6 years.
The side effects of ofatumumab include a reaction the first time you have the drug which can cause breathlessness, skin rash, a high temperature (fever) and shivering (rigors). You have medicine beforehand to try to prevent a reaction. The study team will watch you very closely during the treatment. If you do have a reaction, they can slow down or stop the drip until the side effects stop. They can then start the drip again at a slower rate.
Other possible side effects of ofatumumab include
- A drop in the number of white blood cells causing an increased risk of infection
- Feeling faint
- Feeling sick (nausea)
Very rarely, ofatumumab may cause a condition called progressive multifocal leukoencephalopathy (PML). This is serious and affects the
The most common side effects of chlorambucil and bendamustine include
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Feeling or being sick
- Mouth ulcers
- Tiredness (fatigue)
How to join a clinical trial
Professor Andrew Pettitt
Cancer Research UK
Chugai Pharma UK Ltd
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
This is Cancer Research UK trial number CRUKE/10/052.