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LOTIS-5: A phase 3 trial of loncastuximab tesirine and rituximab in people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

A trial testing a new treatment called loncastuximab tesirine, combined with rituximab, in people with DLBCL that has not responded (refractory) or has come back (relapsed) after previous treatment.


Trial aim and background

This is a phase 3 trial to find out if loncastuximab tesirine plus rituximab is more effective than chemotherapy plus antibody therapy for people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

The trial is in two parts:

  • Part 1 is to test the safety of loncastuximab tesirine plus rituximab in people with relapsed or refractory DLBCL. 
  • Part 2 is to compare loncastuximab tesirine plus rituximab with chemotherapy plus rituximab. 

Loncastuximab tesirine is a type of targeted treatment called an antibody–drug conjugate: an antibody joined to a toxic drug. The antibody sticks to a protein called CD19 found on the surface of some lymphoma cells, and carries the drug straight to them. It is given through a drip into the vein (intravenously) once every 3 weeks. 


Who can enter

Adults with diffuse large B-cell lymphoma (DLBCL), including double-hit or triple-hit lymphoma, or lymphoma that has transformed from a slower-growing type of lymphoma, which has come back or not responded after at least one previous course of treatment and are not able to have a stem cell transplant may be eligible for this trial.


Locations

Recruitment is taking place in the following UK locations:

  • NHS Greater Glasgow and Clyde, Glasgow
  • The Christie NHS Foundation Trust, Manchester
  • The Royal Marsden NHS Foundation Trust, Sutton

Further information

More information about what treatments are involved, the criteria you must meet in order to take part in the trial and where this trial is taking place are available at: https://clinicaltrials.gov/ct2/show/NCT04384484

Lymphoma Action are not able to refer people to specific trials. If you are interested in taking part in this trial we recommend that you print the trial summary and discuss it with your medical team. They can advise you on whether you might be eligible for the trial and how you can take part based on your individual circumstances.