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PQR309: a phase 2 trial testing a targeted drug, PQR309, in people with relapsed or refractory systemic (whole-body) lymphoma

People with any type of lymphoma who have had at least two previous courses of treatment might be able to enter this trial.


Purpose of trial

The aim of the trial is to find out if a new drug called ‘PQR309’ is safe and can help control or reduce lymphoma in people with any type of lymphoma that has come back (relapsed) or didn’t respond (was refractory) to previous treatment.


Treatments

PQR309 is a targeted drug that works by blocking signalling pathways that control how cells grow and divide. In lymphoma, abnormal cells grow and divide in an uncontrolled way. Treating these abnormal cells with PQR309 can block their growth and division or even cause them to die.

Everyone in this trial is given PQR309 capsules to take on 2 days of each week.

Different doses are being tested to identify the best dose first in terms of safety (side effects) and then in terms of whether the drug can control or reduce lymphoma.

You will be given information about the treatment and you will be told how often to take the capsules.

You continue to take the capsules for as long as your lymphoma is responding to treatment and you don’t have any side effects bad enough to have to stop treatment. You can decide to stop participating in the trial at any time and you don’t have to give a reason. 


Who can enter

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

Around 100 people are needed for this trial.

You may be able to enter if:

  • You have relapsed or refractory lymphoma and have had at least 2 previous courses of treatment including chemotherapy with antibody therapy.
  • If you have relapsed chronic lymphocytic leukaemia (CLL), you may be eligible if you’ve had at least 1 previous course of treatment.
  • Your diagnosis must be confirmed by a biopsy.
  • Your lymphoma is measurable by the tests used in the trial.
  • You are generally well, even if you are not well enough for physically strenuous work or activity.
  • Your blood test results meet the requirements for this trial.
  • You are able and willing to swallow capsules.
  • You and your partner are willing to use reliable contraception if there is any chance of you or your partner becoming pregnant during the trial and for at least 90 days after you finish treatment.
  • You are 18 or over.

You will not be able to enter if:

  • Your immune system is lowered due to allogeneic stem cell transplant or HIV or you’ve had immunosuppressive therapy in the 4 weeks prior to starting trial treatment.
  • You’ve had an autologous stem cell transplant in the 3 months before starting trial treatment.
  • You are having other anti-cancer treatments or have had chemotherapy, immunotherapy or major surgery in the 21 days prior to starting trial treatment.
  • You are taking medicines that reduce acidity in your digestive system, like proton-pump inhibitors (for example omeprazole), H2-antagonists (for example ranitidine) and antacids.
  • You have digestive problems that mean you can’t properly absorb the study drug.
  • You’ve taken another investigational drug in the 21 days prior to starting trial treatment.
  • You’ve previously had a bad reaction to a similar drug.
  • Your lymphoma is in your central nervous system (CNS; brain and spinal cord) and this is causing symptoms.
  • You haven’t recovered from the side effects of your previous treatment.
  • You have serious heart problems or very high blood pressure or you have had procedures on your heart, a heart attack or severe/unstable angina in the last 3 years.
  • You have diabetes that isn’t well controlled.
  • You have a serious infection at the time of treatment or any other medical condition that your doctor thinks makes it unsafe for you to enter the trial.
  • You are pregnant or breastfeeding.

Further information

More information about this trial is available at clinicaltrials.gov