A trial looking at romidepsin and carfilzomib for people with peripheral T cell lymphoma that has come back or treatment has stopped working (RomiCar)

Cancer type:

Blood cancers
High grade lymphoma
Lymphoma
Non-Hodgkin lymphoma

Status:

Open

Phase:

Phase 1/2

This trial is looking at 2 drugs called romidepsin and carfilzomib for people with T cell lymphoma. It is for people with peripheral T cell lymphoma Open a glossary item that has come back or treatment has stopped working.

More about this trial

Peripheral T cell lymphoma (PTCL) is a type of high grade (quickly growing) non Hodgkin lymphoma (NHL) that affects blood cells called T cells.

Doctors often use chemotherapy to treat PTCL. But sometimes it continues to grow, or comes back after the treatment has finished. So doctors are looking for new ways to treat people in this situation.

In this trial, researchers are looking at 2 drugs called romidepsin and carfilzomib. Romidepsin blocks proteins (enzymes) called histone deacetylases (pronounced dee-as-et-isle-azes). Cells need these enzymes to grow and divide. The research team hope that blocking them may stop cancer growing. Drugs that block these enzymes are called histone deacetylase inhibitors, or HDAC inhibitors.

Carfilzomib is a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.

The researchers want to see if romidepsin and carfilzomib help people who have already had other treatment for PTCL.

The aims of the trial are to

  • Find the best dose of romidepsin and carfilzomib
  • Find out  if the combination of romidepsin and carfilzomib can help people with peripheral T cell lymphoma
  • Learn more about the side effects

Who can enter

You may be able to join this trial if all of the following apply.

  • You have peripheral T cell lymphoma Open a glossary item and tests show it is one of the subtypes being studied in this trial (the trial team can advise you about this)
  • Your lymphoma has come back or treatment has stopped working
  • A CT scan shows the you have at least one area of lymphoma that measures more than 1.5cm across or you have an enlarged spleen Open a glossary item that measures more than 14cm long
  • You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • You have satisfactory blood test results
  • You are at least 16 years old
  • You are willing to use reliable contraception during the trial and for 3 months afterwards if there is any chance you or your partner could become pregnant

You cannot join this trial if any of these apply.

  • You have lymphoma that has spread to your brain or spinal cord (central nervous system)
  • Your doctors are planning for you to have any other treatment for peripheral T cell lymphoma during the time you are taking part in the trial unless this includes low dose steroids. This may also include steroid creams, inhalers or eye drops.
  • You are having steroid treatment to your whole body to help with a side effect of having a stem cell transplant with somebody else's cells called graft versus host disease (GVHD Open a glossary item)
  • You have had treatment with drugs known as ‘histone deactylase inhibitors’ or ‘proteasome inhibitors’ in the past (your doctor can advise you about this)
  • You have had radiotherapy Open a glossary item in the last month unless it was for symptom control only, or in the last 2 weeks if you had radiotherapy to one area
  • You have had hormone therapy or immunotherapy Open a glossary itemin the last month
  • You have had treatment as part of a clinical trial in the last month
  • You haven’t recovered from the side effects of other treatments unless they are mild
  • You are having antibiotics through a drip into a vein for an infection
  • You aren’t able to swallow tablets
  • You are taking any medication that blocks an enzyme called CYP3A4 apart from dexamethasone
  • You have certain heart problems (the trial team can advise you about this)
  • You have high blood pressure
  • You have had major surgery in the last 4 weeks
  • You have an active hepatitis B or C infection
  • You are HIV positive
  • You have had any other cancer in the past 3 years unless it was successfully treated apart from non melanoma skin cancer Open a glossary item or very early cancer of the cervix (CIS)
  • You have any other medical or mental health condition that the trial team thinks could affect you taking part in this trial
  • Are pregnant or breast feeding

Trial design

This is a phase 1/2 trial. The researchers need 58 people to join. There are 2 parts to this trial. You will join part 1 or part 2. Everyone taking part will have romidepsin and carfilzomib.

In the 1st part, doctors are trying to find the highest safe dose of romidepsin and carfilzomib to give. The first 3 patients taking part will have the lowest dose. If they don’t have any serious side effects, the next 3 patients will have a higher dose. And so on, until they find the best dose. This is called a dose escalation study. When they find the best dose, the 2nd part of the trial can begin.

In the 2nd part of the trial, doctors want to see how well treatment works. You have the highest safe dose of romidepsin and carfilzomib.

You have romidepsin through a drip into a vein once a week for 3 weeks and then 1 week with no romidepsin. You have carfilzomib through a drip into a vein twice in the 1st week and then once a week for 3 weeks. Each 4 week period is called a cycle of treatment. Having romidepsin takes about 4 hours. Having carfilzomib takes about 30 minutes.

If you join part 1 or part 2, you have treatment for up to 8 months. If the treatment is helping and you don’t have any bad side effects, the trial doctors will talk to you about having it for longer.

Samples for research
If you agree to take part in this study, the researchers will ask for a sample of your lymph node tissue that was removed when you had a biopsy Open a glossary item.They may ask to take another biopsy during treatment if your lymphoma gets worse. They will also ask for 4 extra blood samples. If you don’t want to give these samples for research you don’t have to. You can still take part in the trial.

Hospital visits

You see the doctor and have some tests before you can take part in this trial. These include

  • Physical examination
  • Heart trace (ECG Open a glossary item)
  • Heart scan (echocardiogram Open a glossary item) or a MUGA scan Open a glossary item
  • Bone marrow test
  • CT scan
  • Blood tests

You go to hospital to have romidepsin and carfilzomib. On the 1st day of each treatment cycle you see the doctor for a physical examination and some blood tests. You have more blood tests in the 1st and 2nd week of treatment.

You have a CT scan every 2 months during treatment.

You have regular ECG’s for both parts of the trial. You have these more frequently in the first 2 months of treatment if you are joining part 1.

When you finish treatment you see the doctor for a check up and a CT scan. If you stop treatment and your lymphoma hasn’t got worse, you see the trial team every 3 months for a year. After that the trial team will see how you are getting on every 6 months. This may be at a routine hospital or via your GP.

If your lymphoma has got worse during the trial, the doctors may recommend other treatment but the trial team will continue to follow you up at routine hospital appointments for up to 3 years.

Side effects

The most common side effects of romidepsin and carfilzomib include

Location

Birmingham
Leeds
Leicester
Liverpool
London
Manchester
Nottingham
Oxford
Plymouth
Southampton

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Graham Collins

Supported by

Bloodwise
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Birmingham

Other information

 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11008

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

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