CITADEL-202: a phase 2 trial testing a new drug, INCB050465, for people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

This trial might be suitable for people who have already had several courses of treatment for diffuse large B-cell lymphoma (DLBCL).

Purpose of trial

The aim of this trial is to test the safety and effectiveness of a new targeted drug called ‘INCB050465’ for people with diffuse large B-cell lymphoma (DLBCL) that has come back (relapsed) or didn’t respond (was refractory) to at least 2 previous lines of treatment.


Treatments

INCB050465 is a cell signal blocker. It blocks signals that allow lymphoma cells to grow. It works in a similar way to idelalisib, which is a drug that is already used for some types of lymphoma.

Everyone in this study has INCB050465. You take it as tablets once a day for 8 weeks. You then take it once a week. You continue to take the treatment for as long as it is helping you.


Who can enter

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

Around 120 people are needed for this trial.

You may be able to enter if

  • You have relapsed or refractory DLBCL.
  • You have had 2–5 previous courses of treatment.
  • You are not suitable for high-dose chemotherapy and an autologous stem cell transplant.
  • Your lymphoma is measurable with the tests used in the trial.
  • A sample of your biopsy is available or you are willing to have a fresh biopsy.
  • You are well enough to look after yourself and are up and about at least 50% of the day even if you are unable to work.
  • Your blood and other health test results are satisfactory.
  • You are 18 or over.

You will not be able to enter if

  • You have primary mediastinal large B-cell lymphoma (PMBL).
  • Your lymphoma is in your central nervous system (CNS; brain and spinal cord) or you have episodes of seizures (fits) that are not under control.
  • You have had an autologous stem cell transplant in the last 3 months or an allogeneic stem cell transplant in the last 6 months or you have active graft versus host disease (GvHD) after an allogeneic stem cell transplant.
  • You are taking or have recently taken medicines that could interfere with the trial treatment.
  • You have previously been treated with idelalisib , ibruitinib or similar drugs.

Further information

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