Purpose of trial
The aim of this trial is to test the safety and effectiveness of loncastuximab tesirine (formerly called ADCT-402) in treating people with DLBCL and other large B-cell lymphomas. It aims to find out:
- if loncastuximab tesirine can reduce lymphoma
- if responses to loncastuximab tesirine are durable (last a long time)
- how loncastuximab tesirine behaves in the body
- more about the side effects of loncastuximab tesirine.
Loncastuximab tesirine is a type of treatment called an ‘antibody-drug conjugate’. It is made up of an antibody joined to a drug that should kill lymphoma cells. The antibody targets a protein called ‘CD19’, which is found on the surface of many lymphoma cells. The antibody carries the drug to the lymphoma cells wherever they are in the body.
You have the treatment intravenously (through a drip into your vein) once every 3 weeks. It takes around 30 minutes for the drug to be given.
You continue to have loncastuximab tesirine every 3 weeks for up to 1 year, as long as the treatment is benefitting you and any side effects are manageable.
Who can enter
Your consultant can give you advice on whether you might be suitable for this trial.
Approximately 140 people are needed for this trial.
You may be able to enter if:
- You have DLBCL, PMBL, double-hit lymphoma or triple-hit lymphoma, or DLBCL that has transformed from follicular lymphoma.
- You have already had at least two courses of systemic (whole-body) treatment and your lymphoma did not respond (refractory lymphoma) or has come back (relapsed).
- A sample of your biopsy is available for tests.
- Your lymphoma cells have the protein CD19.
- 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.
- A pregnancy test shows that you are not pregnant and you agree to use contraception during the trial and for at least 16 weeks after your last dose of trial treatment if you or your partner is possibly able to get pregnant.
- You are 18 or over.
You won’t be able to enter if:
- You’ve had loncastuximab tesirine before.
- You’ve had a bad reaction to a CD19 antibody before.
- You have Burkitt lymphoma.
- You’ve had a self (autologous) stem cell transplant in the last 30 days or a donor (allogeneic) stem cell transplant in the last 60 days.
- You have active graft-versus-host disease (GvHD – a complication of a donor stem cell transplant).
- You have post-transplant lymphoproliferative disorder (your lymphoma is associated with an organ transplant).
- You’ve had another cancer unless it was a localised cancer (your doctor can advise you if this applies to you).
- You have HIV, hepatitis B or hepatitis C.
- Your lymphoma has transformed (changed) from follicular lymphoma to diffuse large B-cell lymphoma.
- You have certain other health conditions that might make it unsafe for you to take part in the trial, including but not limited to autoimmune problems (where your body attacks itself), Stevens-Johnson syndrome or toxic epidermal necrolysis (serious skin conditions), excessive fluid in your body, or heart conditions.
- Your lymphoma is in your central nervous system (CNS; brain and spinal cord).
- You’ve had major surgery, radiotherapy, chemotherapy or other anti-cancer treatments in the last 14 days.
- You’ve had another experimental treatment in the past 4 weeks.
- You need a live vaccine.
- You have not sufficiently recovered from the side effects of your previous treatment.
More information about this trial is available at www.clinicaltrials.gov/ct2/show/NCT03589469