A trial looking at inotuzumab ozogamicin for diffuse large B cell lymphoma (INCA)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
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
Trial design
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 . They will use these samples to find out more about diffuse large B cell lymphoma.
Hospital visits
You see the doctor to have some tests before taking part in this trial. These tests include
- A physical examination
- Blood tests
- Heart trace (
ECG ) - CT scan
- Bone marrow test
- Lumbar puncture (if needed)
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.
Side effects
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
- Tiredness
- Feeling or being sick
- Feeling weak
- High temperature (fever)
- Headaches
- Tummy (abdominal) pain
- Nosebleeds
- 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.
We have information about gemcitabine, R-CVP and their side effects in our cancer drugs section.
Recruitment start:
Recruitment end:
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.
Chief Investigator
Dr Andrew McMillan
Supported by
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Pfizer
University College London (UCL)
Other information
This is Cancer Research UK trial number CRUKE/11/060.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
