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TRANSFORM: A phase 3 trial testing lisocabtagene maraleucel CAR T-cell therapy in people with relapsed or refractory high-grade B-cell non-Hodgkin lymphoma

This trial is testing a CAR T-cell therapy called liscabtagene maraleucel (also known as JCAR017) in adults with relapsed or refractory high-grade B-cell non-Hodgkin lymphomas who are able to have a stem cell transplant.


Purpose of trial

The aim of this trial is to find out whether lisocabtagene maraleucel (a CAR T-cell therapy) is as safe and effective as high-dose chemotherapy and a stem cell transplant for adults who have high-grade B-cell non-Hodgkin lymphomas who have not responded to previous treatment (refractory lymphoma) or whose lymphoma has come back (relapsed) after first-line therapy.


Treatments

People who take part in this trial are randomly put into one of two treatment groups:

  • Group 1 has the current standard treatment for people with relapsed or refractory high-grade B-cell lymphoma. This involves having a course of chemotherapy to reduce your lymphoma as much as possible. Your medical team can choose the chemotherapy regimen they feel is most appropriate for you. You then have high-dose chemotherapy and a self (autologous) stem cell transplant.
  • Group 2 has 3 days of chemotherapy drugs called fludarabine and cyclophosphamide, followed by treatment with lisocabtagene maraleucel.

You can’t choose which treatment you have and neither can your doctor. You are told which treatment you are having and given information about it.

Lisocabtagene maraleucel is a type of targeted treatment called CAR T-cell therapy.

In CAR T-cell therapy, white blood cells called T cells are collected from your own bloodstream. These cells are sent to a lab where they are genetically modified (changed) to allow them to recognise and kill lymphoma cells. These genetically modified T cells are known as ‘CAR T cells’. After they have been modified, the CAR T cells are grown in the lab until there are enough of them to treat your lymphoma. They are then given back to you, like a blood transfusion.


Who can enter

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

Around 182 people are needed for this trial.

You may be able to enter if:

You won’t be able to enter if:

  • You have B-cell skin lymphoma (primary cutaneous large B-cell lymphoma), EBV-positive DLBCL, Burkitt lymphoma or chronic lymphocytic leukaemia/small lymphocytic lymphoma that has transformed to DLBCL (Richter transformation).
  • You are not able to have a stem cell transplant.
  • You are due to have a donor (allogeneic) stem cell transplant.
  • You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment.
  • You’ve had a similar type of treatment before.
  • You have active hepatitis B or active hepatitis C.
  • You have HIV.
  • You have an illness affecting your central nervous system (CNS; brain and spinal cord).
  • You have an autoimmune condition that requires treatment to dampen down your immune system.
  • You have an infection that isn’t controlled by medication.
  • You’ve had heart failure, a heart attack, unstable angina, or a procedure to widen the blood vessels in your heart in the past 6 months.
  • You have had another cancer in the past, unless you have been cancer-free for at least 2 years or you have had certain localised cancers.
  • You are pregnant or breastfeeding.

Further information

More information about this trial is available at clinicaltrials.gov/ct2/show/NCT03575351