Polatuzumab vedotin plus rituximab, ifosfamide, carboplatin and etoposide (Pola-R-ICE) versus R-ICE

• Research type

  Research Study

• Full title

  An open-label, prospective Phase III clinical study to compare polatuzumab vedotin plus rituximab, ifosfamide, carboplatin and etoposide (Pola-R-ICE) with rituximab, ifosfamide, carboplatin and etoposide (R-ICE) alone as salvage therapy in patients with primary refractory or relapsed diffuse large B-cell lymphoma (DLBCL).

• IRAS ID

  1004045

• Contact name

  Sabrina Pigur

• Contact email

  polarice@g-wt.de

• Eudract number

  2019-002962-10

• ISRCTN Number

  ISRCTN13438605

• Clinicaltrials.gov Identifier

  NCT04833114

• Research summary

  This clinical trial is for patients diagnosed with a type of lymphoma called diffuse large B-cell lymphoma (DLBCL). The aim of the study is to see how a new treatment (polatuzumab vedotin) works in comparison to an existing treatment (R-ICE). Patients must have either refractory (not responded to initial treatment) or relapsed (returned) disease.
  Half of the patients will be given the standard treatment of rituximab, ifosfamide, carboplatin and etoposide (R-ICE) and half of the patients will be given the standard treatment plus the new drug, polatuzumab vedotin, rituximab, ifosfamide, carboplatin and etoposide (Pola-R-ICE)
  This is an international study, being conducted across Germany, Spain, Austria and the UK. The UK will aim to recruit 75 patients, across 15 hospital sites.
  Treatment will be given in ‘cycles’, which means that patients will have their treatment over a few days and then have a rest to allow the body to recover. In this trial each cycle will be 21 days and each patient will receive 3 cycles. After the treatment phase, patients will continue to be followed up every 3 months, for a minimum of 21 months and until the last patient recruited has completed their 21 months of follow up.
  The study involves patients giving a number of tissue and blood samples at various stages of the study. There is also the option to provide additional blood samples which will allow scientists to look at the disease (DLBCL) at an individual cell (genetic) level to see if this is linked to the way the disease responds to treatment.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  21/SC/0358

• Date of REC Opinion

  24 Dec 2021

• REC opinion

  Further Information Favourable Opinion