A Phase 1b study in patients with B-Cell Chronic Lymphocytic Leukemia

• Research type

  Research Study

• Full title

  A Multicenter, Double-Blind, Randomized, And Placebo-Controlled Phase Ib Study Evaluating The Safety Of Adding Tocilizumab To Standard Premedication Prior To Administration Of Obinutuzumab In Combination With Chlorambucil In Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia And Comorbidities.

• IRAS ID

  165400

• Contact name

  John Gribben

• Contact email

  j.gribben@qmul.ac.uk

• Sponsor organisation

  F Hoffmann­La Roche Ltd

• Eudract number

  2014-004594-16

• Duration of Study in the UK

  3 years, 8 months, 31 days

• Research summary

  This study is taking place in four countries in the world. The study is looking whether adding a new pre-medication, Tocilizimab, in addition to standard pre-medications, reduces the occurrence of infusion related reactions in patients who receive Obinituzumab and Chlorambucil treatment for their CLL. The study will include 60 patients, 40 of whom will receive the Tocilizumab pre-medication in addition to standard pre-medications and 20 patients who will receive a placebo infusion in addition to standard pre-medications before their first infusion of Obinituzumab.

  The study will look at the safety and tolerability of the combination of treatments, as well as some exploratory analyses to help better understand infusion related reations several biomarker analyses to try and understand further the infusion related reactions and their sequela in patients treated with Obinutuzumab.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  15/NE/0070

• Date of REC Opinion

  16 Mar 2015

• REC opinion

  Further Information Favourable Opinion