REMoDL-B: What We Found From Your Clinical Trial

REMoDL-B: What We Found From Your Clinical Trial

28.11.2022

We are writing to you because you kindly volunteered to take part in a clinical trial called REMoDL-B. We have analysed the results and this newsletter is a brief summary of what we found.

MAIN FINDINGS
REMoDL-B was a study to see if adding the drug bortezomib to standard treatment (known as R-CHOP) would benefit patients with diffuse large B-cell lymphoma. We found that for most participants, adding bortezomib did not make a difference to whether or not their lymphoma was likely to come back.
Participants who received bortezomib were slightly more likely to report peripheral neuropathy (reduced feeling in hands and feet), but otherwise people did not experience more problems when taking the extra drug. Almost 90% of participants completed all 6 cycles of treatment.

However, as an unexpected outcome of the trial we have identified a small group of patients whose lymphoma was worse than others and who may benefit from other types of treatment in the future. That type of lymphoma is called molecular highgrade (MHG) lymphoma.

It is also possible that patients with MHG and also those with activated B-cell (ABC) lymphoma have benefitted from the bortezomib, and we are still analysing results in more detail. The outcomes will be published next year.

Those are the main findings, but if you wish to read a more detailed account of this analysis, the results have been published in a scientific journal, The Lancet Oncology, Vol. 20, No. 5, p649–662.

A further scientific paper detailing the new MHG group has been published here, Journal of Clinical Oncology, 2019 Jan 20;37(3):202-212.

If you cannot find these articles online or your local library cannot access them, please contact us and we will be pleased to help.

MORE INFORMATION ABOUT REMoDL-B

WHAT WAS THE PURPOSE OF THE STUDY?
The aim of REMoDL-B was to find out if adding bortezomib to standard therapy (a drug combination called R-CHOP) would provide clinical benefit to those with large B-cell lymphoma. The name REMoDL-B is a summary of the scientific description – A Randomised Evaluation of Molecular Guided Therapy for Diffuse Large B-cell Lymphoma with Bortezomib.
WHO VOLUNTEERED TO TAKE PART?
1129 patients with diffuse large B-cell lymphoma volunteered to participate in the REMoDL-B trial, in the UK and in Switzerland, from June 2011 until June 2015.
HOW DID WE DELIVER THE STUDY?
For the first cycle of treatment, we gave all patients the standard therapy, which is RCHOP chemotherapy. Then a computer randomised participants to one of two arms; R-CHOP alone (the control arm) or RB-CHOP, ie R-CHOP with bortezomib (the intervention arm). Participants stayed on their arm for the five remaining cycles of treatment.

At the start of treatment, we analysed patients’ lymphoma biopsies to establish which subtype of diffuse large B-cell lymphoma was present. This information allowed us to ensure there were balanced number of subtypes in each treatment arm after randomisation. The subtypes we identified were either Activated B-Cell (ABC), Germinal Centre B-cell (GCB) or Unclassified (Unc). If you wish to find out what subtype
you had please contact your trial team.

This trial was sponsored by the University Hospital Southampton NHS Foundation Trust and was managed on their behalf by Southampton Clinical Trials Unit.

Finally, we would like to say thank-you once again for volunteering to take part in the REMoDL-B study. You have helped us understand more about lymphoma and how to treat it.