SADAL: a phase 2 trial testing a new targeted drug called selinexor for people with relapsed or refractory diffuse large B-cell lymphoma

You might be able to enter this trial if you have no other treatment options and you have diffuse large B-cell lymphoma (DLBCL) that has relapsed (come back) or was refractory (didn’t respond) to previous treatment. 


Purpose of trial

The aim of this trial is to see if selinexor, a new targeted drug, can help people with DLBCL. This trial was previously open testing two different doses of selinexor. It has re-opened testing the best dose of selinexor from the previous part of the trial.

Results from the previous part of the trial have been published.


Treatments

Everyone in this trial has selinexor.

Selinexor is the first drug of its kind. It works by activating pathways that lead to cell death in cancer cells.

You take selinexor orally (by mouth) twice a week for 3 weeks of every 4-week cycle. You have a week with no treatment before starting the next cycle of treatment.

You keep taking the drug as long as you don’t have serious side effects and your lymphoma does not get worse.


Who can enter

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

Around 130 people are needed for this trial.

You may be able to enter if:

  • You have DLBCL.
  • Your lymphoma has relapsed after or was refractory to at least 2 but no more than 5 previous treatments.
  • Your lymphoma is measurable by the tests used in the trial.
  • Your lymphoma has grown since your last treatment.
  • Your last anti-cancer treatment was at least 14 weeks ago if you did not respond to the treatment or at least 60 days ago if you did respond to the treatment.
  • You are well enough to enter the study.
  • You are 18 or over.

You will not be able to enter if:

  • Your DLBCL has transformed (changed) from a slower-growing type of lymphoma.
  • You have another type of lymphoma as well, such as MALT lymphoma or Hodgkin lymphoma.
  • You have primary mediastinal (thymic) large B-cell lymphoma (PMBL).
  • Your lymphoma is in your central nervous system (brain and spinal cord).
  • You are able to have high-dose therapy and an autologous stem cell transplant.
  • You are HIV positive or have active hepatitis C or hepatitis B.

You can’t swallow tablets or have issues with your digestive system that mean you might not absorb the drug.


Further information

More information about this trial is available at clinicaltrials.gov.