RIAltO version 3

• Research type

  Research Study

• Full title

  RIAltO: A Randomised Investigation of Alternative Ofatumumab-containing regimens in less fit patients with CLL

• IRAS ID

  76092

• Contact name

  Andrew Pettitt

• Sponsor organisation

  University of Liverpool

• Eudract number

  2011-000919-22

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  This is a randomised, controlled, phase III trial comparing ofatumumab and chlorambucil (O-Chl) with ofatumumab and bendamustine (O-B) in patients with chronic lymphocytic leukaemia (CLL) who are considered not fit enough to receive more intensive combination chemotherapy.The primary purpose of the trial is to establish if O-B is more effective at controlling the disease compared with O-Chl.670 patients are to be enrolled in total (335 per treatment arm) from approximately 100 centres throughout the United Kingdom.Patients will receive between 3 and 12 cycles of treatment depending on which treatment arm they are allocated to and how well they respond to the treatment. The schedule of treatment is as follows:Arm 1: O-Chl repeated every 28 days for up to 12 cycles depending on clinical response after cycles 3, 6 and 9.Arm 2: O-B repeated every 28 days for up to 6 cycles depending on clinical response after cycle 3.All patients will be followed up for a minimum of 2 years from trial entry.Depending on the routine practice of the centre involved, 1-3 additional CT scans and bone marrow biopsies will be performed during the course of the trial. These are the only trial tests (other than blood tests) that are above and beyond those normally performed routinely at all centres.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  11/NW/0548

• Date of REC Opinion

  14 Sep 2011

• REC opinion

  Further Information Favourable Opinion