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STELLAR: a phase 2 trial of acalabrutinib in people with Richter syndrome

This trial is testing a targeted drug called acalabrutinib, on its own or with chemotherapy and antibody therapy, in people with Richter syndrome.


Trial aim and background

The aim of this trial is to find out if adding acalabrutinib to standard treatment can improve the response and outcome of participants with chronic lymphocytic leukaemia (CLL) that has changed (transformed) to a faster-growing type of lymphoma. This is called Richter syndrome.

There are two parts to this trial: a randomised trial (the main element of the trial) and two additional treatment groups (known as ‘cohorts’).

The randomised part of the trial

People with newly-diagnosed Richter syndrome who have not had CHOP chemotherapy and have not had ibrutinib in the last 4 weeks can be considered for the randomised part of the trial. People in this part of the trial are randomly allocated to one of two treatment groups:

  • rituximab plus CHOP chemotherapy (known as R-CHOP or CHOP-R)
  • R-CHOP plus acalabrutinib.

The cohorts

  • People who took part in the randomised part of the trial and had R-CHOP on its own might be given the opportunity to enter Cohort 1 if their disease comes back (relapses) or does not respond (refractory). People in Cohort 1 are treated with acalabrutinib on its own.
  • People with newly-diagnosed Richter syndrome who have not had CHOP chemotherapy but who have been treated with ibrutinib in the last 4 weeks can be considered for Cohort 2. People in Cohort 2 do not take part in the randomised part of the trial. People in Cohort 2 are treated with R-CHOP plus acalabrutinib.

Who can enter

Adults with Richter syndrome (chronic lymphocytic leukaemia that has transformed to a faster-growing type of lymphoma) and have not had previous treatment for it may be eligible for this trial.


Locations

  • Belfast City Hospital, Belfast
  • Royal Bournemouth Hospital, Bournemouth
  • University Hospital of Wales, Cardiff
  • Beatson West of Scotland Cancer Centre, Glasgow
  • St James's University Hospital, Leeds
  • Leicester Royal Infirmary, Leicester
  • King's College Hospital, London
  • St Bartholomew's Hospital, London
  • University College London Hospital, London
  • Christie Hospital, Manchester
  • Norfolk and Norwich University Hospital, Norwich
  • Nottingham City Hospital, Nottingham
  • Churchill Hospital, Oxford
  • Derriford Hospital, Plymouth
  • Royal Hallamshire Hospital, Sheffield
  • Southampton General Hospital, Southampton

Further information

 

More information about what treatments are involved, the criteria you must meet in order to take part in the trial and where this trial is taking place are available at: https://clinicaltrials.gov/study/NCT03899337

Lymphoma Action are not able to refer people to specific trials. If you are interested in taking part in this trial we recommend that you print the trial summary and discuss it with your medical team. They can advise you on whether you might be eligible for the trial and how you can take part based on your individual circumstances.