Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.
A trial looking at inotuzumab ozogamicin for diffuse large B cell lymphoma (INCA)
This trial is looking at inotuzumab ozogamicin with R-CVP for diffuse large B cell lymphoma.
More about this trial
The standard treatment for diffuse large B cell lymphoma (DLBCL) is a combination of chemotherapy drugs and a monoclonal antibody called rituximab. This is called R-CHOP. Because one of the chemotherapy drugs can affect the heart, R-CHOP isn’t suitable for everyone. For people in this situation doctors usually give another drug combination called R-CVP. But this doesn’t work as well as R-CHOP. So doctors are looking for another drug to replace the one that affects the heart.
We know from research that adding the chemotherapy drug gemcitabine to R-CVP may work just as well for people who can’t have R-CHOP.
Inotuzumab ozogamicin (pronounced in-oh-too-zoo-mab oz-oh-ga-my-sin) is a monoclonal antibody. The researchers think that adding it to R-CVP may work for people who can’t have R-CHOP.
The aim of this trial is to compare gemcitabine and R-CVP with inotuzumab ozogamicin and R-CVP to find out which works best for people with diffuse large B cell lymphoma (DLBCL) who can’t have R-CHOP.
Who can enter
You may be able to enter this trial if you
- Have diffuse large B cell lymphoma and your lymphoma cells make the CD20 protein (they are CD20 positive)
- Have at least 1 area of lymphoma that can be measured on a scan
- Are not able to have treatment with a chemotherapy drug from the
anthracycline chemotherapy group– your doctor can advise about this
- Have satisfactory blood test results
- 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 at least 1 year afterwards if there is any chance you or your partner could become pregnant
- Are at least 18 years old
You cannot enter this trial if
- Your lymphoma has spread to your brain or spinal cord and is causing symptoms
- You had a previous diagnosis of a low grade lymphoma and you have had treatment that reaches the whole body (systemic therapy), such as chemotherapy
- You had another cancer and are still having side effects from treatment or there is a 1 in 10 chance (10%) or more of your cancer coming back
- You have had treatment for your lymphoma
- You have problems with your liver
- Your doctor thinks you may have a problem with alcohol
- You are known to be HIV, hepatitis B or hepatitis C positive
- You have had a bad reaction to other monoclonal antibodies
- You have a serious infection
- You are pregnant or breastfeeding
This is a phase 2 trial. It will recruit 132 people. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to choose which group you are in.
Before you are put into a treatment group, you may have been taking steroids. If your doctor thinks you are well enough you will be put into 1 of 2 treatment groups. If your doctor thinks you aren’t well enough you won’t take part in the trial.
People in group 1 will have gemcitabine, rituximab, cyclophosphamide, vincristine and prednisolone (Gem-R-CVP).
People in group 2 will have inotuzumab ozogamicin, rituximab, cyclophosphamide, vincristine and prednisolone (IO-R-CVP).
You have gemcitabine, rituximab, cyclophosphamide, vincristine and inotuzumab ozogamicin as a drip into a vein. You have gemcitabine twice in 3 weeks and the other drugs once every 3 weeks. Each 3 week period is called a cycle of treatment.
Prednisolone is a tablet. You take it for the first 5 days of each cycle of treatment.
You have gemcitabine, cyclophosphamide, vincristine, inotuzumab ozogamicin and prednisolone for 6 cycles and rituximab for 8 cycles, as long as the treatment is helping you and the side effects aren’t too bad.
The trial team will ask you to fill out a questionnaire before you start treatment, after your 3rd treatment, at the end of treatment and at 6 months and 2 years after treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.
They will also ask for extra blood samples and a sample of your lymphoma that was removed when you had a
You see the doctor to have some tests before taking part in this trial. These tests include
During treatment you see the doctor twice every 3 weeks for a physical examination and blood tests. You have heart traces done every 3 weeks. You have a CT scan after 3 months.
At the end of treatment you see the doctor for the same tests as at the start, apart from the heart trace. You have a CT scan at the end of treatment, then after another 3 months and 1 year.
After treatment you see the doctor every 3 months for the 1st year, every 4 months for the 2nd year, every 6 months for the 3rd year and then every year after that.
The most common side effects of inotuzumab ozogamicin are
- A drop in blood cells causing an increased risk of infection, bruising and bleeding
- Constipation or diarrhoea
- Changes to the way your liver works
- Feeling or being sick
- Feeling weak
- High temperature (fever)
- Tummy (abdominal) pain
- Shortness of breath
- An allergic reaction – this may include high temperature and a drop in blood pressure
Your doctor will talk to you about the possible side effects of treatment before you agree to take part in the trial.
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 McMillan
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University College London (UCL)
This is Cancer Research UK trial number CRUKE/11/060.