A trial looking at treatment for B cell non-Hodgkin lymphoma that has got worse (Glo-BNHL)

Cancer type:

Blood cancers
Children's cancers
Non-Hodgkin lymphoma

Status:

Open

Phase:

Phase 2/3

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 Open a glossary item
  • radiotherapy Open a glossary item
  • stem cell transplant Open a glossary item or bone marrow transplant Open a glossary item
  • targeted drugs Open a glossary item
  • immunotherapy Open a glossary item

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 targeted drugs Open a glossary item. 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 monoclonal antibody Open a glossary item which can attach to two different targets on the cancer cell at the same time. It works by helping your immune system Open a glossary item cells find and kill lymphoma cells. 

Loncastuximab tesirine is a type of drug called an antibody drug conjugate Open a glossary item (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. 
 
Who can take part

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)
  • had a transplant of your own stem cells or bone marrow (autologous transplant Open a glossary item) 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 Open a glossary item (GvHD) in the past 28 days that needed treatment that reaches the whole body, treatment that damps down the immune system Open a glossary item, 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 Open a glossary item 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 Open a glossary item or Bloom syndrome that is caused by a gene change (mutation Open a glossary item)
  • 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 Open a glossary item. 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 Open a glossary item 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 course of chemotherapy Open a glossary item 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 cycles of treatment Open a glossary item. 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 (intrathecal injection Open a glossary item). 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 (biopsy Open a glossary item) 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:

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
During treatment you might have scans 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:

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 Open a glossary item and low sperm count Open a glossary item 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

Birmingham
Bristol
Manchester

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

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

Last review date

CRUK internal database number:

19867

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Last reviewed:

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