P+R-ICE

• Research type

  Research Study

• Full title

  Pembrolizumab in combination with R-ICE chemotherapy in relapsed/refractory diffuse large B-cell lymphoma.

• IRAS ID

  1004066

• Contact name

  Andrew Davies

• Contact email

  a.davies@soton.ac.uk

• Sponsor organisation

  University Hospital Southampton NHS Foundation Trust

• Eudract number

  2018-001886-18

• ISRCTN Number

  ISRCTN86607306

• Clinicaltrials.gov Identifier

  NCT05221645

• Research summary

  More than 13,000 new cases of non-hodgkins lymphoma are diagnosed in the UK each year. Diffuse large B cell lymphoma (DLBCL) is the most common accounting for around 5,000 new cases per annum. Rituximab with CHOP chemotherapy is the standard first line treatment but in a third of patients, it does not work. The majority of these patients will die from their disease, as the success of salvage treatments is limited after prior treatment with rituximab. Patients who have few other complications are able to have high dose therapy (stem cell transplant) after 2nd line (+) treatment but only if they are in complete remission. There is a growing need to find better second line treatments that allow patients eligible for high dose therapy, to receive it.
  This is a phase two, open label, multi-centre, randomised trial for patients who have been treated at least once for their lymphoma but it has returned (relapsed) or the treatment did not work (refractory). Sixty five patients will be randomised (with a 3:1 randomisation to the experimental arm) 16 control (Arm A) patients and 49 experimental (Arm B) patients so that 44 evaluable patients are treated with Pembrolizumab in combination with R-ICE (rituximab, ifosfamide, carboplatin and etoposide) chemotherapy. Arm A patients will receive 3 cycles of a standard regimen known as R-ICE. Arm B patients will receive 3 cycles of R-ICE in combination with pembrolizumab. Patients will be recruited from 10 participating NHS sites in the UK. Those who have a complete response and a partial response on both arms, following initial treatment will go on to have a stem cell transplant and then if on Arm B will receive maintenance pembrolizumab for one year. Patients will be followed up to monitor their continuing response to the treatment.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  21/EE/0248

• Date of REC Opinion

  10 Jan 2022

• REC opinion

  Further Information Favourable Opinion