CITADEL: a phase 2 trial to find out if T-cells that target EBV can be used to treat EBV-positive extranodal NK/T-cell lymphoma

This study aims to find out if giving you large numbers of T cells that target EBV can reduce extranodal NK/T-cell lymphoma.


Purpose of trial

Extranodal NK/T-cell lymphoma is a rare, fast-growing type of lymphoma. It is very strongly associated with the Epstein-Barr virus (EBV). EBV is a very common virus, which also causes glandular fever.

Around 9 in 10 people have been infected by EBV by adulthood and the vast majority do not go on to develop lymphoma.

It is not known why a few people who have EBV go on to develop lymphoma.

Extranodal NK/T-cell lymphoma can be difficult to treat, particularly if it relapses (comes back) or you cannot have standard treatment.

When your immune system reacts to EBV infection, it produces EBV-specific T cells (white blood cells that fight infection) that help to kill infected cells. This trial is testing whether giving you large numbers of these cells could help clear the lymphoma. Your own T cells are used so that your immune system does not react against them.

You might be able to enter this trial if you have extranodal NK/T-cell lymphoma and you have limited treatment options because:

  • your lymphoma has relapsed (come back)
  • you are not fit enough for standard treatment.

People with extranodal NK/T-cell lymphoma at high risk of relapsing after standard treatment might also be able to enter this study. The trial treatment is then made and saved in case you do relapse.


Treatments

You have blood taken before treatment in order to produce the EBV-positive T-cells. You are then given 2 intravenous (given into a vein) infusions of EBV-specific T-cells 2 weeks apart.

Your lymphoma is assessed 8 weeks after starting treatment. If it has reduced or stayed the same, you can have up to 3 more treatments at 8 weeks, 3 months and 6 months after starting treatment.


Who can enter

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

Around 35 people are needed for this trial

You may be able to enter if:

  • You have EBV-positive extranodal NK/T-cell lymphoma that has relapsed, is at high risk of relapse or you cannot have standard treatment.
  • You’ve had previous treatment with a chemotherapy regimen (combination of drugs) containing asparginase and at least 1 cycle of chemotherapy that included gemcitabine or you cannot have asparginase-based treatment.
  • Your last course of chemotherapy was completed at least 2 weeks ago and you have recovered from the side effects of your treatment.
  • You weigh at least 35 kg.
  • You are well enough to look after yourself and up and about more than 50% of your waking hours, even if you are not well enough to work.
  • You and your partner are willing to use reliable contraception during treatment and for at least 6 months after treatment has finished if there is any chance of you or your partner becoming pregnant.
  • You can breathe well enough without being given oxygen.
  • You are 18 or over.

You will not be able to enter if:

  • Your lymphoma is in your central nervous system (brain and spinal cord) or you have NK cell leukaemia or hemophagocytic lymphohistiocytosis.
  • You are HIV positive or have hepatitis C, hepatitis B or syphilis.
  • You have another cancer as well or you’ve had another cancer in the last 5 years, unless it was one of a group of certain localised cancers.
  • You’ve had an allogeneic stem cell transplant or an organ transplant.
  • You’ve had systemic (whole body, not applied only to the skin) steroids in the past 10 days.
  • You’ve had another experimental drug in the last 4 weeks.
  • You’ve had radiotherapy in the last 3 weeks.
  • You’ve had major surgery in the last 2 weeks.
  • You have significant heart problems.
  • You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment.
  • You are pregnant or breastfeeding.

Further information

More information about this trial is available at clinicaltrials.gov.