"I am glad that taking part in a trial might help others on their own cancer journey.”
A study of ofatumumab with CHOP chemotherapy for Richter's syndrome (CHOP-OR)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at ofatumumab and CHOP chemotherapy for people with chronic lymphocytic leukaemia (CLL) who have just been diagnosed with Richter’s syndrome.
Advanced CLL can sometimes develop into a condition called Richter’s syndrome which is a type of
Doctors usually treat Richter’s syndrome with a combination of chemotherapy drugs called CHOP. You may also have a drug called rituximab. This treatment can help to improve symptoms, but the lymphoma often comes back.
In this trial, researchers are looking at a drug called ofatumumab. It is a type of biological therapy called a monoclonal antibody similar to rituximab. People taking part will have ofatumumab with CHOP chemotherapy to get rid of the lymphoma. This is called induction treatment. They then have more ofatumumab on its own to try to stop the lymphoma coming back. This is called maintenance treatment.
The aims of the trial are to
- See if CHOP chemotherapy and ofatumumab helps people with Richter’s syndrome
- Learn more about the side effects
Who can enter
You can enter this trial if you
- Have chronic lymphocytic leukaemia and have recently had a
biopsythat shows you now have diffuse large B cell lymphoma (Richter’s syndrome)
- Have had or are willing to have a CT scan
- Are well enough to take part in the study and don’t need complete care (performance status 0, 1, 2 or 3)
- Are willing to use a reliable form of contraception during the trial and for a year after finishing treatment if there is any chance you could become pregnant
- Are at least 18 years old
You cannot enter this trial if you
- Have CLL that has spread to your brain or spinal cord (central nervous system)
- Have had treatment for diffuse large B cell lymphoma in the last 6 months
- Have any other type of cancer that requires treatment, apart from non melanoma skin cancer that has not spread
- Are taking part in another trial or have had any other experimental drug in the last month
- Have had a stroke in the last 6 months
- Have heart pain (angina), heart failure, or any other heart problem that is a cause for concern
- Have an infection that needs treatment or any other serious medical condition
- Are hepatitis B or HIV positive
- Are pregnant or breastfeeding
This phase 2 trial aims to recruit 35 people. Everybody taking part will have CHOP chemotherapy and ofatumumab.
You have induction treatment in 3 week cycles of treatment. On the first day of each treatment cycle you have cyclophosphamide, doxorubicin and vincristine through a drip into a vein. You take prednisolone tablets on the first 5 days of each treatment cycle.
In the first cycle of treatment, you have ofatumumab once a week through a drip into a vein. From the 2nd treatment cycle onwards, you have ofatumumab just on the first day. You have 6 cycles of induction treatment, then you start maintenance treatment.
You have maintenance treatment in 8 week treatment cycles. You have ofatumumab on the first day of each cycle. You have up to have 6 cycles of maintenance treatment. So the study treatment can last for more than a year all together.
You will be asked to fill out some questionnaires at the beginning of the study, a number of times during treatment, and when you see the study team after you finish your treatment. The questionnaires will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.
You will see the doctors and have some tests before you start treatment. The tests include
You will have a lymph node biopsy if you have not had one in the last 6 weeks.
You go to hospital to have blood tests and treatment
- Weekly for the first 3 weeks of treatment
- Every 3 weeks for the rest of the induction treatment
- Every 8 weeks during the maintenance treatment
You have a CT scan at weeks 13 and 20 weeks during treatment. You see the study team and have another CT scan at week 72, which is about 3 months after you finish treatment. You may need to have another bone marrow test or lymph node biopsy at this time.
The common side effects of CHOP chemotherapy include
- A drop in the number of blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Feeling or being sick
- Constipation or diarrhoea
- Mouth ulcers
- Numbness and tingling in hands and feet (peripheral neuropathy)
- Dry skin
- Tiredness (fatigue)
- Loss of appetite
- Hair loss
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 reduce the risk of a reaction and 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.
Ofatumumab causes people to have a more severe form of hepatitis B. You will have a blood test to check for hepatitis B before you join the study. If this is positive, you will not be able to join this study.
Very rarely, ofatumumab may cause progressive multifocal leukoencephalopathy (PML). This is a serious infection affecting the
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.
Dr Anna Schuh
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Oxford
This is Cancer Research UK trial number CRUKE/09/038.