RO5541007 in lymphoma

• Research type

  Research Study

• Full title

  A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL COMPARING THE EFFICACY AND SAFETY OF POLATUZUMAB VEDOTIN IN COMBINATION WITH RITUXIMAB AND CHP (R-CHP) VERSUS RITUXIMAB AND CHOP (R-CHOP) IN PREVIOUSLY UNTREATED PATIENTS WITH DIFFUSE LARGE B-CELL LYMPHOMA

• IRAS ID

  234222

• Contact name

  Andrew Davies

• Contact email

  A.Davies@soton.ac.uk

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2017-002023-21

• Duration of Study in the UK

  7 years, 3 months, 1 days

• Research summary

  The purpose of this study is to test if the study drug is safe and effective at treating patients with Diffuse Large B-Cell Lymphoma.

  About 875 people will participate in the study. Eligible patients will be randomly assigned to receive combination treatment in one of the following two arms:

  Arm A – Polatuzumab Vedotin + R-CHP:
  - Polatuzumab vedotin
  - Rituximab
  - Cyclophosphamide
  - Doxorubicin
  - Placebo for vincristine
  - Prednisone

  Arm B – Placebo + R-CHOP:
  - Placebo for polatuzumab vedotin
  - Rituximab
  - Cyclophosphamide
  - Doxorubicin
  - Vincristine
  - Prednisone

  Patients in each arm will be asked to take the study treatment for approximately 18 to 24 weeks. The study doctor will then ask them to return to the study centre 4 to 8 weeks after their last dose of study treatment. Patients will remain on the study for about 5.5 years.

  A number of assessments and procedures may be performed during the study including physical examinations, blood sample tests, radiological assessments (CT/MRI and/or PET), heart function assessments (ECHO/MUGA), ECG (electrocardiograms), bone marrow examinations and complete quality of life questionnaires. These assessments are performed as part of the evaluation to determine if the study drug is effective and safe.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  18/SC/0037

• Date of REC Opinion

  6 Mar 2018

• REC opinion

  Favourable Opinion