CITADEL-204: a phase 2 trial testing INCB050465 for people with marginal zone lymphoma who have had previous treatment

This trial is for people with marginal zone lymphoma, including MALT lymphoma, nodal marginal zone lymphoma, and splenic marginal zone lymphoma.


Purpose of trial

The aim of this trial is to find out if INCB050465 could be a safe and effective treatment for people with marginal zone lymphoma who have had previous treatment.


Treatments

INCB050465 is a cell signal blocker that works in a similar way to idelalisib, which is a drug already available for some people with lymphoma. It works by stopping the B cells from staying alive and dividing. 

There are two treatment groups in this trial:

  • people who have previously received ibrutinib or a similar drug
  • people who have not received ibrutinib or a similar drug

You take INCB050465 orally (by mouth) as tablets or capsules. 

In each treatment group, two different dosing schedules are being tested. Everyone takes INCB050465 at a dose of 20 mg every day for 8 weeks. You then take:

  • 20 mg once a week, or
  • 2.5 mg every day.

You are told how often to take INCB050465.

You continue to take treatment for as long as it is benefitting you.


Who can enter

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

120 people are needed for this trial.

You may be able to enter if:

You won't be able to enter if:

  • Your lymphoma has transformed (changed) into a high-grade (faster-growing) type of lymphoma.
  • You have lymphoma in your central nervous system (brain, spinal cord and eyes).
  • You have been treated with idelalisib or a similar drug before.
  • You have had a donor (allogeneic) stem cell transplant in the last 6 months or a stem cell transplant using your own cells (autologous) in the last 3 months.
  • You have active graft-versus-host disease (a complication of donor stem cell transplants).
  • You have liver disease, including hepatitis B virus or hepatitis C virus.
  • You are pregnant or breastfeeding.
  • You have any other problems that your doctor thinks might make it unsafe for you to have the study treatment.

Further information

More information about this trial is available at www.clinicaltrials.gov/ct2/show/study/NCT03144674.

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