A study of blinatumomab after chemotherapy for newly diagnosed diffuse B cell lymphoma

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 study is for people who have a high risk of their cancer coming back after chemotherapy.

More about this trial

Diffuse large B cell lymphoma is a type of non Hodgkin lymphoma. Doctors usually treat diffuse large B cell lymphoma (DLBCL) with chemotherapy and a targeted cancer drug (biological therapy Open a glossary item ) called rituximab. In some people, there is an increased risk that the lymphoma might come back. So, researchers are looking at ways to improve treatment.

In this study, they are looking at drug called blinatumomab. It is a type of targeted cancer drug called a monoclonal antibody. Antibodies help the white blood cells (a part of the immune system Open a glossary item ) to defend the body against bacteria and viruses. They can also help attack cancer cells.

Blinatumomab seeks out particular proteins on the surface of cells. One part binds to the surface of a cancer cell. The other part binds to the surface of a white blood cell. This helps the white blood cells to find and kill the cancer cells.

This study is in 2 parts. In part 1, you have standard treatment Open a glossary item with chemotherapy and rituximab. If this helps, you might be able to join part 2 and have blinatumomab.

The aims of the study are to:

find out how safe blinatumomab is
find out how well it works
learn more about the side effects

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Part 1
You might be able to join part 1 of this study if all of the following apply. You

Have newly diagnosed diffuse large B cell lymphoma that has a high risk of coming back after treatment
Are able to have 6 cycles of standard chemotherapy and rituximab
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
Have satisfactory blood test results
Are at least 18 years old

You cannot join part 1 if the following apply. You

Have already had treatment for your lymphoma
Have had anti-CD19 treatment in the past
Have lymphoma in your brain or spinal cord (central nervous system)
Have had any other cancer in the last 3 years apart from very early cancers that were successfully treated
Have had a serious condition that affects your brain such as epilepsy, seizures (fits), a stroke or a severe brain injury
Have an autoimmune disease or have had one in the past that might have affected your brain or spinal cord
Have an infection that needs treatment
Have had treatment as part of a clinical trial within 30 days of joining this study
Are allergic to blinatumomab, immunoglobulins or anything they contain
Have hepatitis B or hepatitis C
Have HIV
Have any other serious medical condition or mental health problem that the study team think could affect you taking part
Are pregnant or breast feeding

Part 2
You might be able to join part 2 of the study if you had 6 cycles of chemotherapy and rituximab and one of the following applies. Your lymphoma

disappeared completely (a complete response)
got a bit better (a partial response)
stayed the same (stable disease)

And you are willing to use reliable contraception for up to 48 hours after the last dose of blinatumomab.

Trial design

This phase 2 study is taking place worldwide. The researchers need 38 people to take part including 2 from the UK.

This study is in 2 parts. In part 1, everyone has standard chemotherapy and rituximab. For example, you might have a treatment called R-CHOP. This includes the drugs:

rituximab
cyclophosphamide
doxorubicin
vincristine
prednisolone

You have treatment in cycles. Each 2 or 3 week period is called a cycle of treatment. You have 6 cycles over 21 weeks.

If the chemotherapy helps, you might be suitable to join part 2 and have blinatumomab. Your doctor will discuss other treatment options with you, if your lymphoma got worse during the chemotherapy.

You have blinatumomab over 8 weeks followed by 4 weeks without treatment. This 12 week period is 1 cycle of treatment. You have 1 cycle to begin with.

You have blinatumomab through a central line Open a glossary item into a vein in your chest. You have it through a pump. The pump gives you a continuous dose over 8 weeks. It fits into a small bag that you can attach to a belt. So you can go home and walk around as normal.

If the treatment helps, you might have a 2nd blinatumomab treatment. The study team can tell you more if this applies.

study diagram

Samples for research
The researchers will ask for samples of your lymphoma (a biopsy Open a glossary item ) that were removed when you had bone marrow tests. They also ask to take some extra blood samples. Where possible, you have these at the same time as your routine blood tests.

They plan to look at:

what happens to blinatumomab in the body (pharmacokinetics )
substances called biomarkers to help work out why treatment might work for some people and not for others
changes (mutations ) to any genes

You don’t have to give the samples for genetic testing if you don’t want to. You can still take part in the study.

Hospital visits

You see a doctor and have some tests before you can take part. These include:

physical examination
blood tests
heart trace (ECG )
CT scan
PET scan

You might also have a bone marrow test and lumbar puncture. Open a glossary item

You have your chemotherapy and rituximab in the hospital day unit. You shouldn’t need to stay overnight. The study team can give you more information about the individual chemotherapy drugs you have and how often you have them.

You stay overnight in hospital for the first 3 days of blinatumomab. You might have to go back to hospital for a short stay if the doctors need to change the dose. Otherwise you continue having the treatment at home. You go to hospital once or twice a week for check ups. However, you might not need such frequent visits if a study nurse can go to your house to change the blinatumomab infusion bag.

When you finish treatment, you go to hospital every 3 months for a check up for up to a year.

Side effects

Blinatumomab is a new drug for diffuse B cell lymphoma, so there might be some side effects we don’t know about yet. The study team will monitor you during the time you have treatment and you’ll have a phone number to call them if you are worried about anything.

So far the most common side effects include:

a drop in the number of blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
tummy pain
diarrhoea or constipation
tiredness (fatigue)
chest pain
bone, joint or back pain
pain in the arms, legs and hands
cough
rash
problems falling asleep or staying asleep
weight gain
high levels of sugar (glucose) in the blood
low levels of magnesium or potassium in the blood