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:

Blood cancers

High grade lymphoma

Lymphoma

Non-Hodgkin lymphoma

Status:

Closed

Phase:

Phase 2

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).

INCA trial diagram

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 biopsy Open a glossary item . 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