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.
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 have marginal zone lymphoma (MALT lymphoma, nodal marginal zone lymphoma, splenic marginal zone lymphoma), confirmed by biopsy.
- You are willing to have a biopsy of your lymphoma if a sample of your lymphoma is not available for tests.
- Your lymphoma is measurable with the tests used in the trial.
- Your blood and other health test results are satisfactory.
- You are 18 or over.
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.
More information about this trial is available at www.clinicaltrials.gov/ct2/show/study/NCT03144674.