PARADIGME: a phase 2 trial comparing two different doses of Betalutin and lilotomab in people with relapsed or refractory follicular lymphoma

This trial is recruiting people with follicular lymphoma who have already had at least two courses of treatment but their lymphoma has come back (relapsed) or did not respond (was refractory) to treatments containing anti-CD20 antibodies, such as rituximab.


Purpose of trial

The aim of this trial is to compare two different doses of a new type of treatment called Betalutin®, and to find out:

  • how effective each dose is at reducing lymphoma
  • more about the safety of each dose. 

This trial is the second part of the LYMRIT 37-01 trial, which tested this treatment in different types of lymphoma and identified the doses for further testing. Initial results of LYMRIT 37-01 have already been presented, and showed promising response rates in people with follicular lymphoma. 


Treatments

Betalutin® is a radio-immunotherapy, which is an antibody attached to a radioactive molecule. The antibody binds (sticks) to lymphoma cells and brings the radiation directly to the lymphoma cells, and kills them. The radiation does not last long in your body. You will be asked to follow a few restrictions in the first few days. You will be given more information about these restrictions, but examples include:

  • Don’t get too close to children or pregnant women; for example, minimise hugging and holding small children.
  • Don’t share a bed. 

The restrictions only apply for a few days and you can then resume normal contact.

The antibody in Betalutin® is called lilotomab. It binds to a protein called ‘CD37’, which is found on several different types of B-cell lymphoma cells, including follicular lymphoma cells. The radiation only acts over a very short distance, so it can target the lymphoma without damaging other parts of your body.

This trial is randomised. If you agree to take part and you are eligible for the trial, you are randomly assigned to one of two dose groups. Everyone receives the new treatment, but the treatment doses are different depending which group you are in. You can’t choose which group you are in and neither can your specialist. 

You have one cycle of treatment, which is given on 2 days, 2 weeks apart: 

  • On the first day, you have an injection of rituximab to reduce the number of B cells in your blood. You do not have to stay in hospital overnight. 
  • Two weeks later, you have an injection of lilotomab (the antibody without the radioactive molecule) followed by an injection of Betalutin® on the same day. Most people can go home on the same day.

All of the treatments are given as an injection into a vein. 

After receiving your Betalutin® treatment, you are asked to return to your hospital for regular check-ups. The check-ups are more frequent initially (for the first year) and then 6 monthly for a total of 5 years.


Who can enter

Your consultant can give you advice on whether you might be suitable for this trial.

Approximately 130 people are needed for this trial.

You may be able to enter if:

  • You have follicular lymphoma.
  • You have already had at least two courses of chemotherapy and your lymphoma did not respond (refractory lymphoma) or has come back (relapsed) within 6 months of your last anti-CD20 treatment.
  • Your previous treatment included an anti-CD20 antibody (for example rituximab) and chemotherapy that included a type of drug called an ‘alkylating agent’ (for example the CHOP regimen).
  • Your lymphoma is measurable by the tests used in the trial.
  • You are well enough to take part in the trial.
  • Your blood and other health test results are satisfactory.
  • You are 18 or over.

You won’t be able to enter if:

  • You’ve had a stem cell transplant.
  • You have HIV, hepatitis B or hepatitis C.
  • Your lymphoma has transformed (changed) from follicular lymphoma to diffuse large B-cell lymphoma.
  • You’ve previously had total body irradiation (radiotherapy to your whole body).
  • You’ve had another anti-cancer treatment in the past 4 weeks.
  • Your lymphoma is in your central nervous system (CNS; brain and spinal cord).
  • You’ve had another cancer unless it was a localised cancer (your doctor can advise you if this applies to you). 
  • You’ve had a drug targeting the protein CD37 before.
  • You’ve previously had a bad reaction to any of the treatments used in the trial.
  • You’ve had a live vaccine in the last 30 days.

Further information 

More information about this trial is available at www.clinicaltrials.gov/ct2/show/study/NCT01796171

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Further information and support

If you would like further information or would like to talk about any aspect of your lymphoma, please contact us on 0808 808 5555.