"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial comparing ofatumumab and rituximab for lymphoma that has come back (ORCHARRD)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at a new biological therapy called ofatumumab and comparing it to rituximab as treatment for people who have diffuse large B cell (DLBCL) or follicular lymphoma that has come back.
If you have advanced disease, doctors usually treat these types of non Hodgkin lymphoma with a drug called rituximab and chemotherapy. Sadly the lymphoma can come back and doctors may treat it with rituximab and chemotherapy again, followed by a stem cell transplant.
Doctors know that if you have had rituximab in the past, it doesn’t always work as well the second time you have it. They want to see if a new drug called ofatumumab is better than rituximab for people having treatment for the second time.
In this study doctors will compare DHAP chemotherapy and rituximab with DHAP chemotherapy and ofatumumab, followed by stem cell transplant to treat the lymphoma that has come back.
Ofatumumab is a type of biological therapy called a monoclonal antibody. Doctors already use ofatumumab to treat some types of leukaemia and want to know how well it works treating these types of lymphoma.
The aim of this study is to find out if ofatumumab is better than rituximab for people with diffuse large B cell (DLBC) or follicular lymphoma that has come back.
Who can enter
You can enter this trial if you
- Have diffuse large B cell lymphoma (DLBCL) or follicular lymphoma (grade 3b at diagnosis) that has come back after treatment or did not go away with treatment with rituximab and chemotherapy
- Have a protein called CD20 on your lymphoma cells (CD20 positive NHL)
- Have lymphoma than can be seen on PET scan
- Have lymphoma that can be measured on CT scan, with an area that is at least 2cm across, or 1.5cm if there are 2 areas or more
- Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
- Are able to have high dose chemotherapy and stem cell transplant - your doctor will advise you about this
- Are willing to use reliable contraception during the trial and for 1 year after treatment if there is any chance you or your partner could become pregnant
- Have satisfactory blood test results
- Are at least 18 years old
You cannot enter this trial if you
- Have lymphoma in your brain or spinal cord (central nervous system)
- Have had treatment for your lymphoma other than rituximab, chemotherapy or radiotherapy
- Have had chemotherapy in the last 2 weeks
- Have had an experimental drug as part of another clinical trial in the last 4 weeks
- Are HIV, hepatitis B or hepatitis C positive
- Have an infection that cannot be controlled with medication, or any other condition that could make it unsafe for you to take part in this trial
- Have had a heart attack in the last 6 months or another serious heart condition that is not well controlled with medication
- Have had any other cancer, apart from
carcinoma in situor non melanoma skin cancer or a cancer that was successfully treated more than 5 years ago
- Have already had an anti CD 20 monoclonal antibody apart from rituximab
- Are pregnant or breastfeeding
This is a randomised trial. The people taking part are put into 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
People in groups 1 and 2 have DHAP chemotherapy. This is a combination of the following drugs
You have treatment in 3 week periods. Each 3 week period is called a cycle of treatment. You will have up to 3 cycles.
People in group 1 have ofatumumab and DHAP chemotherapy on day 1 of each treatment cycle and ofatumumab on day 8 of the 1st cycle only. This is repeated every 3 weeks.
People in group 2 have rituximab and DHAP chemotherapy on day 1of each treatment cycle and rituximab on day 8 of the 1st cycle only. This is repeated every three weeks.
If the treatment has not worked then you will not have a stem cell transplant but discuss further treatment options with your lymphoma specialist. You will see the study doctors for a physical examination and blood test at the end of the trial treatment. The study doctors will then see you every 3 months for 2 years after treatment, and then every 6 months for the next 3 years.
You will also be asked to fill out a questionnaire
- Before you start treatment
- On day 1 of each treatment cycle
- Before your stem cell transplant
- At the end of your treatment
- Then every 3 months for 2 years
- Every 6 months for 3 years after that
The questionnaire will ask about any side effects you have had and about how you have been feeling. This is called a quality of life study.
If you agree to take part in this study, the researchers will ask your permission to take an extra blood sample before you start treatment. You do not have to give this extra sample for research if you do not want to. You can still take part in the trial. The researchers will use the sample to look at why the treatment works better for some people than others.
You will see the doctors and have some tests before you start treatment. The tests include
On day 1 of each treatment cycle, you have a physical examination and blood tests.
You will be in hospital for 3 to 5 days during each cycle. You have a CT scan at the end of cycles 2 and 3, and a PET scan at the end of cycle 3.
During cycle 2 or 3 you will visit the hospital daily for up to 5 days to have your stem cell collection.
If the treatment has worked then you will have a stem cell transplant. You will stay in hospital for at least 4 weeks for this. Your doctor will discuss this with you.
After you have had your stem cell transplant you will have a physical examination, blood tests and a bone marrow biopsy (if necessary)
- Every 3 months for 2 years
- Then every 6 months for 3 years
You will have a CT scan 1 year and 2 years after starting the study.
As with most treatments, ofatumumab has some side effects. It is quite a new drug so there may be side effects we don’t know about yet. But the most common side effects we do know about are
- Fever and chills
- A drop in blood cells
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.
When you have rituximab you may have side effects such as
- Fever and chills
- Feeling sick
- Itchy rash
DHAP chemotherapy has the following common side effects
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 Andrew McMillian
Experimental Cancer Medicine Centre (ECMC)
HOVON Dutch-Belgian Cooperative Trial Group for Hematology-Oncology
National Institute for Health Research Cancer Research Network (NCRN)