RomiCar: a phase 1/2 trial to find the best dose and test the effectiveness of 2 newer drugs - romidepsin and carfilzomib - in people with relapsed or refractory peripheral T-cell lymphoma

This trial is testing new targeted drugs for people who have PTCL that has already been treated but needs more treatment.


Purpose of trial

People with peripheral T-cell lymphoma (PTCL) are usually treated with chemotherapy. However, PTCL can be difficult to treat. In some people, the lymphoma relapses (comes back) after treatment. Others have PTCL that is refractory (doesn’t respond) to chemotherapy. The aim of this trial is to test whether a combination of 2 newer drugs can help people who have relapsed or refractory PTCL.


Treatments

The drugs involved in the study are:

  • Romidepsin, which is a histone deacetylase inhibitor. It blocks the activity of histone deacetylases (HDACs), which are proteins that help cells grow and divide
  • Carfilzomib, which is a proteasome inhibitor. It upsets the balance of proteins within the cells. This disruption seems to be particularly harmful to certain types of lymphoma cells, which are then no longer able to work properly and die.

Everyone in this trial has both romidepsin and carfilzomib.

There are 2 parts to the trial:

  • Part 1 is to find out the highest safe dose of both drugs. This is done by ‘dose escalation’. Participants are treated in groups of 3. The first 3 participants have the lowest dose. The next 3 have a higher dose. This continues until the highest safe dose is identified. The highest dose that doesn’t cause serious side effects is used in part 2 of the trial.
  • Part 2 is to test how well the highest safe dose of the study drugs works. People entering this part of the trial all have the same doses of study drugs.

You might enter part 1 or part 2.

You have both drugs intravenously (through a drip into a vein).

The drugs are given in 4 week cycles. In each cycle you have:

  • romidepsin once a week for 3 weeks
  • carfilzomib twice a week for 3 weeks
  • 1 week with no treatment.

You can have up to 8 cycles, but it may be possible to continue treatment for longer if you are responding well and not having any serious side effects.


Who can enter

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

Around 58 people are needed for this trial overall.

You may be able to enter if:

  • You have relapsed or refractory PTCL (peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma, enteropathy associated T-cell lymphoma, extranodal NK/T-cell lymphoma, transformed mycosis fungoides, hepatosplenic T-cell lymphoma).
  • Your lymphoma is measurable by the tests used in the trial.
  • 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.
  • Your blood and other health test results are satisfactory.
  • You and your partner are willing to use reliable contraception during treatment and for at least 3 months after treatment if there is any chance of you or your partner becoming pregnant.
  • You are 16 or over.

You will not be able to enter if:

  • You still have significant side effects from your previous treatment.
  • You have been treated with a similar drug before.
  • Your doctor plans to treat you with another anti-cancer drug.
  • You need intravenous antibiotics for an infection You can’t swallow tablets or capsules.
  • Your lymphoma is in your central nervous system (brain and spinal cord).
  • You’ve had surgery in the last 4 weeks You have certain heart problems or pulmonary hypertension, which is raised blood pressure in the blood vessels that carry blood from your heart to your lungs.
  • 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 Cancer Research UK