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PRIMO: A phase 2 trial of duvelisib in people with relapsed or refractory peripheral T cell lymphoma

This trial is testing a targeted drug called duvelisib in people with peripheral T cell lymphoma (PTCL) that has come back (relapsed) or not responded (refractory) after previous treatment.


Purpose of trial

The trial is in two parts.

  • The first part of the trial aims to find the best dose of duvelisib to use for people with peripheral T-cell lymphoma (PTCL) that has come back (relapsed) or not responded (refractory) after previous treatment.
  • The second part aims to find out if the dose of duvelisib selected in the first part is safe and effective for people with relapsed or refractory PTCL.

Treatments

Everybody in the trial is treated with duvelisib. Duvelisib is a type of targeted drug called a cell-signal blocker. It targets a protein called PI3K, which plays an important role in the growth and survival of B lymphocytes (the type of white blood cells that become abnormal in B-cell lymphomas).

In the first part of the trial, people are randomly put into one of two treatment groups:

  • People in group 1 start off taking duvelisib 25mg capsules by mouth twice a day. After one cycle of treatment (28 days), you have a scan. If you are responding to treatment, you carry on taking 25mg twice a day. If you are not responding to treatment and you don’t have any troublesome side effects, you move up to a dose of 50mg twice a day. After two more cycles of treatment (56 days), you have another scan. If you are responding to treatment, you carry on taking 50mg twice a day. If you are not responding to treatment and you don’t have any troublesome side effects, you move up again to a dose of 75mg twice a day.
  • People in group 2 take duvelisib 75mg capsules by mouth twice a day.

For the second part of the trial, everybody has the same dose of duvelisib capsules twice a day. The dose depends on the results of part 1 of the trial.

You are told which group you are in and given information about the treatment. You carry on having treatment unless your lymphoma gets worse, you develop troublesome side effects or you decide you no longer want to take part in the trial.


Who can enter

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

Around 120 people are needed for this trial.

You may be able to enter if:

You won’t be able to enter if:

  • You have any health problems that your doctor thinks might make it unsafe for you to have the trial treatment.
  • Your lymphoma has changed (transformed) to a faster-growing type.
  • Your lymphoma is in your central nervous system (CNS; brain and spinal cord).
  • You have or have had another cancer within the last 2 years, except certain localised cancers.
  • You have been treated with a similar drug (such as idelalisib) before.
  • You’re currently taking steroid treatment or medicine to dampen your immune system (immunosuppressants).
  • You’re being treated for an infection.
  • You are pregnant or breastfeeding.

Further information

More information about this trial is available at clinicaltrials.gov/ct2/show/NCT03372057