A trial looking at romidepsin and carfilzomib for peripheral T cell lymphoma (RomiCar)

Cancer type:

Blood cancers

High grade lymphoma

Lymphoma

Non-Hodgkin lymphoma

Status:

Results

Phase:

Phase 1/2

This trial looked at 2 drugs called romidepsin and carfilzomib for people with T cell lymphoma.

It was for people with peripheral T cell lymphoma that had come back (relapsed) or treatment had stopped working (refractory).

The trial was open for people to join between 2015 and 2019. The team reported the results in 2022.

More about this trial

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

When this trial was done, the standard treatment for PTCL was chemotherapy. Sometimes PTCL continues to grow or comes back after treatment. So in this trial doctors were looking for ways to treat people in this situation.

In this trial, researchers looked at 2 drugs called romidepsin and carfilzomib.

Romidepsin blocks proteins (enzymes) called histone deacetylases. Cells need these enzymes to divide and grow. The research team hoped 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 targeted cancer drug Open a glossary item called a cancer growth blocker. It stops signals that cancer cells use to divide and grow.

The aims of this phase 1/2 trial were to:

find the best dose of romidepsin and carfilzomib to give
find out if the combination of romidepsin and carfilzomib works for relasped or refractory peripheral T cell lymphoma
learn more about the side effects

Summary of results

The trial was in 2 parts. Part 1 looked at the best dose of romidepsin and carfilzomib. This was the highest dose that had the fewest side effects. Part 2 tested this dose in more people to see how well it worked.

50 people took part in total. This included 34 people in part 1 and 16 people in part 2.

The team found the best dose of romidepsin and carfilzomib to give.

They also looked at how well treatment worked. They had the results for 34 people. They found the lymphoma:

went away in 5 people (22%)
got a bit better in 6 people (26%)
stayed the same in 6 people (26%)
got worse in 6 people (26%)

The lymphoma also got worse in another 11 people. This was before the researchers could assess if the treatment in this trial was working.

This wasn’t better than the current approved treatments for PTCL at the time of the trial.

Side effects
Treatment can cause side effects. It is important to understand what the serious side effects are for treatment. Doctors class a side effect as serious if people need long term care or hospital treatment. Or if it’s particularly important to the trial treatment.

31 people in this trial had a side effect that was classed as serious. These included:

a serious complication of an infection (sepsis )
fever
infusion reaction
lung infections

Side effects that people have which aren’t serious can be mild or severe. Severe side effects are important but aren't immediately life threatening. The team also looked at the severe side effects of this treatment. The most common severe side effects included an increased risk of:

bruising and bleeding
breathlessness and tiredness
infections

1 person died because of trial treatment.

Conclusion
The trial team found the best dose of romidepsin and carfilzomib to give. They say this combination of treatment was safe, but it didn’t work well enough for most people who have relapsed or refractory peripheral T cell lymphoma (rrPTCL).

Sometimes trials show a different treatment isn’t useful for a particular type or stage of cancer. But these trials still add to our knowledge and understanding of cancer and how to treat it.

More detailed information
There is more information about this research in the reference below.

Please note, the information we link to here is not in plain English. It has been written for healthcare professionals and researchers.

RomiCar
NHS Health Research Authority Website
Accessed July 2023

Where this information comes from
We have based this summary on information from the research team. As far as we are aware, the information they sent us has not been reviewed independently (peer reviewed Open a glossary item ) or published in a medical journal yet. The figures we quote above were provided by the research team. We have not analysed the data ourselves.