A trial looking at treatment for B cell non-Hodgkin lymphoma that has got worse (Glo-BNHL)
Cancer type:
Status:
Phase:
This trial is looking at different types of new medicines to treat B cell non-Hodgkin lymphoma that has come back after treatment or got worse during treatment.
The drugs currently being tested are odronextamab and loncastuximab tesirine
with chemotherapy. Loncastuximab tesirine is also called lonca.
It is open to children and young adults up to and including the age of 25 with B cell non-Hodgkin lymphoma that has come back after treatment or got worse during treatment.
Cancer Research UK supports this trial.
You pronounce odronextamab as oh-dron-ex-ta-mab.
You pronounce loncastuximab tesirine as lon-cas-tuk-si-mab tes-i-reen.
Please note we use the term ‘you’ in this summary, but of course if you are a parent of a child with cancer, we are referring to your child.
More about this trial
Doctors can treat B cell non-Hodgkin lymphoma with:
chemotherapy 
radiotherapy stem cell transplant or bone marrow transplant targeted drugs immunotherapy
They can also use these treatments if the first treatment for the lymphoma stops working or doesn’t work. Researchers are always looking for ways to improve treatment for people in this situation.
In this trial the team are currently looking at 2 . They are:
- odronextamab
- loncastuximab tesirine
Odronextamab is a type of drug called a bispecific antibody. They are also called T cell engagers. It is a type of which can attach to two different targets on the cancer cell at the same time. It works by helping your cells find and kill lymphoma cells.
Loncastuximab tesirine is a type of drug called an (ADC). It is made up of a monoclonal antibody and chemotherapy. Loncastuximab is the monoclonal antibody. This finds the lymphoma cells. The chemotherapy is tesirine. It goes into the lymphoma cell and kills it. You will have a drug combination called modified RICE with the loncastuximab tesirine.
You will have either odronextamab by itself or loncastuximab tesirine with modified RICE. Your doctor will discuss this with you.
The aims of the trial are to find:
- how well odronextamab works
- how well loncastuximab tesirine with modified RICE works
- how safe these treatments are
- more about the side effects
Who can enter
The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
| Below are the general entry conditions for this trial. There are certain entry conditions for treatment with odronextamab and loncastuximab tesirine. Your doctor will know what these entry conditions are. |
You may be able to join this trial if all of the following apply. You:
- have a mature B cell lymphoma such as diffuse large B cell lymphoma (DLBCL), Burkitt lymphoma, Burkitt leukaemia, atypical Burkitt lymphoma, Burkitt like lymphoma, primary mediastinal large B cell lymphoma (PMLBCL) or a not otherwise specified mature B cell lymphoma that came back after treatment or that got worse during treatment. Your doctor will know about this.
- have lymphoma the doctor can measure. Your doctor will know about this.
- are well enough to have treatment. This means you might need quite a lot of help to care for yourself if you are a young adult (Karnofsky performance scale 50 and above). Or you might be a child who gets dressed but might need to lie down for most of the day and might only take part in quiet play and activities (Lansky performance scale 50 and above).
- have satisfactory blood test results
- have satisfactory kidney test results
- are willing to use reliable contraception during treatment and for a time after, if you are sexually active and you or your partner could become pregnant
- are up to 25 years old (inclusive)
Who can’t take part
Cancer related
You cannot join this trial if any of these apply. You:
- have acute B cell lymphoblastic leukaemia (B-ALL)
- have acute B cell lymphoblastic lymphoma (BLBL)
- have lymphoma that first started in brain or the spinal cord
- had a transplant of your own stem cells or bone marrow (
autologous transplant ) within the past 45 days - had a transplant using a donor’s stem cells or bone marrow (allogeneic transplant) within the past 90 days
- have had
graft versus host disease (GvHD) in the past 28 days that needed treatment that reaches the whole body, treatment that damps down the immune system , or both - have had radiotherapy to your brain and spinal cord within the past 28 days, or 90 days if you are to have odronextamab. Or you have any other radiotherapy within the past 14 days.
- have ongoing severe side effects from previous lymphoma treatment
- have had medication that affects the
bone marrow such as chemotherapy within 7 days of joining the trial - have had treatment that is similar to the treatments in this trial. Your doctor will know this.
Medical conditions
You cannot join this trial if any of these apply. You:
- have a medical condition such as
ataxia telangiectasia or Bloom syndrome that is caused by a gene change (mutation ) - have a medical condition called post transplant lymphoproliferative disorder (PTDL). This can happen after an organ transplant or a stem cell transplant from a donor.
- have a medical condition that affects how well the immune system works
- have an infection that is not controlled
- have HIV
- have or had hepatitis B. Your doctor will test for this if you have not had testing for hepatitis B before.
- have certain
heart problems . You have a test that looks at how well your heart works. - have any other medical conditions, mental health conditions or social situations that could affect you taking part
Other
You cannot join this trial if any of these apply. You:
- have a
live vaccine within 28 days of joining the trial. The COVID-19 vaccines are not live vaccines and are allowed. - are allergic or sensitive to any of the treatments or medications used in the trial or any of their ingredients
- are pregnant or breastfeeding
Trial design
In this trial the team are looking at different types of treatments for children and young adults with B cell non-Hodgkin lymphoma that has come back after treatment or got worse during treatment. At the moment there are 2 treatment groups in this trial. We will update this summary as more treatment groups are opened.
The 2 current treatment groups are:
- odronextamab
- loncastuximab tesirine and modified RICE
Your doctor will discuss with you which is the best treatment group for you to go into.
Odronextamab
In this group the team expect to recruit 30 to 60 children or young people worldwide including about 3 children or young people in the UK.
You have odronextamab as a drip into a vein over 4 hours. You have it 2, or 3, times a week for 3 weeks:
- then every week until 12 weeks
- then every 2 weeks until 9 months
- then every 4 weeks for up to 2 years
You might have a before starting the odronextamab. This is to reduce the amount of lymphoma in the body. Your doctor will discuss this with you.
You may need to stay in hospital during the first few weeks of treatment.
You may be able to have odronextamab for up to 2 years as long as it is helping and the side effects aren’t too bad. Your doctor will discuss this with you if it applies to you.
Loncastuximab tesirine and modified RICE
In this group the team expect to have 15 to 30 children or young people worldwide including around 2 children or young people in the UK. You have 3 . Each cycle of treatment is 3 weeks long.
You have loncastuximab tesirine as a drip into a vein.
You have some of the drugs in the RICE combination as a drip into a vein. You may have one of the RICE drugs by mouth. You will also have some other chemotherapy as an injection into the fluid around the brain and spinal cord (). This is called intrathecal chemotherapy. Your doctor will tell you more about RICE and the intrathecal chemotherapy and how you have it.
You may need to stay in the hospital for about a week to have the treatment.
You may be able to have loncastuximab tesirine alone, without modified RICE, after the first 3 cycles. This is as long as this is the best option for you and the side effects aren’t too bad. Your doctor will discuss this with you if it applies to you.
Samples for research
The team take extra blood samples. Where possible they take these blood samples when you have routine blood taken as part of your care.
They will ask for a piece of tissue samples () from previous biopsies. If you have fresh biopsies taken during the trial the team will ask for a piece of the tissue.
Researchers will use these samples to find out:
- what happens to odronextamab and loncastuximab tesirine in the body
- how odronextamab and loncastuximab tesirine affect the body
- more about B cell lymphomas
You must agree to have some of these samples as part of this trial. But you do not have to agree to other samples. Your doctor will tell you more about this.
Hospital visits
You see the doctor for tests before taking part. These tests include:
- a
physical examination - blood tests
- heart trace (ECG), only if you are having odronextamab
- heart scan (ECHO or
MUGA ), only if you are having odronextamab - CT scan or MRI scan. Your doctor will tell you which scan you are to have.
- bone marrow test
- lumbar puncture
Your doctor might need to take a fresh tissue sample (biopsy) of the lymphoma. This is to make sure that you get the best treatment. Your doctor will discuss this with you if a fresh biopsy is needed.
With odronextamab, you may need to stay in hospital during the first few weeks of treatment. With loncastuximab tesirine and modified RICE, you may stay in hospital for about 7 days at the beginning of each cycle. Your doctor can explain this a bit more.
Both groups during treatment
You see the doctor regularly during treatment. This is:
- to see how you are
- for blood tests
- to check for any side effects
Scans for odronextamab group
Children and young people in the odronextamab group have a scan at 12 weeks. This is to see how the treatment is working. If it is working well, you may continue to have odronextamab for up to 2 years.
If it isn’t working well, your doctor will discuss other treatment options.
Scans for loncastuximab tesirine group
You have a scan after each to see how the treatment is working. Your doctor will tell you more about this.
If it isn’t working well, your doctor will discuss other treatment options.
End of treatment visit for both groups
You see the doctor when you have finished all your treatment. This is to see how you are. You might also have blood tests and scans.
Follow up for both groups
You see the doctor for 2 years after treatment. Your doctor will tell you how often they want to see you and what tests you have.
Side effects
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
The possible side effects of odronextamab include:
- high temperature (fever)
- chills
- tiredness and weakness (fatigue)
- feeling or being sick
- changes to how your liver works
- a drop in blood cells causing an increased risk of infection, tiredness, bruising and bleeding
- diarrhoea
- high blood sugar (hyperglycaemia)
- muscle pain, weakness and numbness
- skin changes such as a rash and itching
- lung infection and cough
- low blood pressure
- fast heartbeat
- stiff joints
- headache
- loss of appetite
- infusion reactions such as high temperature (fever) and a rash
Tumour lysis syndrome can be a complication of having some cancer drugs, including odronextamab. When cancer drugs kill the cancer cells, the body breaks down the dead cells. The breakdown of dead cells releases large amounts of substances into the bloodstream. These changes can affect your heart or kidneys. Your doctor will closely monitor your blood levels during treatment.
Another possible side effect is called cytokine release syndrome (CRS). Odronextamab can cause the release of a chemical in the body called cytokines. The side effects of the release of these cytokines can be mild to severe. They can include:
- high temperature
- aching muscles
- low blood pressure
- difficulty breathing
The possible side effects of loncastuximab tesirine include:
- a drop in blood cells causing an increased risk of infection, tiredness, bruising and bleeding
- changes to how the liver works
- feeling sick
- tiredness (fatigue)
- high blood sugar (hyperglycaemia)
- skin changes such as a rash, itching and redness. Your skin will be more sensitive to sunlight.
- swelling
- muscle or joint pain
- breathlessness
- fluid around the heart, lungs or both
- infection such as lung infection. This could be severe, life-threatening or fatal.
- tummy (abdominal) pain
- changes to how the kidneys work
- shrinking of the
testes and low sperm count in males - infusion reactions such as high temperature (fever) and a rash
We have more information about RICE and its side effects.
Your doctor will tell you about the possible side effects of the treatments and answer any questions you may have before you agree to take part.
Location
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
Professor Amos Burke
Supported by
University of Birmingham
Cancer Research UK
Fight Kids Cancer
Regeneron Pharmaceuticals
ADC Therapeutics
Innovative Therapies for Children with Cancer (ITCC)
The European Inter-Group for Childhood Non-Hodgkin Lymphoma (EINCHL)
Children’s Oncology Group
Other information
This is Cancer Research UK trial number CRUK/21/019.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
