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REMoDL-A: A phase 2 trial of a targeted drug called acalabrutinib added to standard treatment for people with diffuse large B-cell lymphoma

This trial is testing acalabrutinib, in combination with R-CHOP, in people with DLBCL who have not been treated before.


Trial aim and background

The aim of this trial is to find out whether adding acalabrutinib to standard treatment for DLBCL is safe and effective.

Everybody who takes part in this trial has one cycle of R-CHOP chemoimmunotherapy. After this, people are randomly allocated to one of two groups:

  • Group 1 has five more cycles of R-CHOP
  • Group 2 has five more cycles of R-CHOP plus acalabrutinib.

R-CHOP (rituximab plus cyclophosphamide, doxorubicin [or hydroxydaunorubicin], vincristine [Oncovin] and prednisolone) is standard treatment for DLBCL. 

Acalabrutinib is a type of targeted drug called a cell signal blocker. It blocks a protein called ‘BTK’ on B cells. This disrupts the signals that help B cells to stay alive and divide. It is already approved for some types of lymphoma. 


Who can enter

Patients over 16 with the following types of lymphoma that tests positive for a protein called CD20 who have not had any previous treatment may be eligible for this trial:


Locations

Recruitment is taking place in the following UK locations:

  • Monklands Hospital, Airdrie
  • Victoria Hospital, Blackpool
  • University Hospital Dorset NHS Foundation Trust (Bournemouth and Poole Hospitals), Bournemouth
  • Queens Hospital, Burton On Trent
  • Addenbrooke's Hospital, Cambridge
  • Royal Derby Hospital, Derby
  • Royal Devon and Exeter Hospital, Exeter
  • Beatson West of Scotland Cancer Centre, Glasgow
  • Ipswich Hospital, Ipswich
  • St James Hospital, Leeds
  • Leicester Royal Infirmary, Leicester
  • Chase Farm and Barnet Hospitals, London
  • Lewisham and Greenwich NHS Trust, London
  • University College London Hospital, London
  • Maidstone Hospital, Maidstone
  • The Christie Hospital, Manchester
  • Milton Keynes University Hospital, Milton Keynes
  • Freeman Hospital, Newcastle
  • Norfolk and Norwich University Hospital, Norwich
  • Nottingham City Hospital, Nottingham
  • Royal Oldham Hospital, Oldham 
  • Churchill Hospital, Oxford 
  • Derriford Hospital, Plymouth
  • Queen Alexandra Hospital, Portsmouth
  • Queen's Hospital, Romford
  • Southampton General Hospital, Southampton
  • Royal Stoke University Hospital, Stoke-on-Trent
  • Singleton Hospital, Swansea
  • Torbay Hospital, Torquay
  • Royal Cornwall Hospital, Truro
  • Worthing and St Richards Hospitals, Worthing, United Kingdom
  • Colchester General Hospital, Colchester
  • East Kent Hospitals NHS Foundation Trust, Canterbury

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/ct2/show/NCT04546620                

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.