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:
Status:
Phase:
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 (
) 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 ) 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 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 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.
Samples for research
The researchers will ask for samples of your lymphoma () 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:
You might also have a bone marrow test and
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
There is a small chance that you might have a mild reaction to blinatumomab. This can cause:
- chills
- fever
- headache
- low blood pressure
- feeling and being sick
There is also a small chance that blinatumomab can cause central nervous system problems such as:
- shaking
- dizziness
- seizures (fits)
- memory loss
Your doctor will keep a close eye on you and treat these straight away. They will explain all the possible side effects before you join the study.
We have information about the side effects of R-CHOP.
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 Nick Morley
Supported by
Amgen
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
