ABT-263 in patients with untreated CLL (Study ABT4710n)

• Research type

  Research Study

• Full title

  A PHASE II, MULTICENTER, RANDOMIZED, CONTROLLED, OPEN-LABEL STUDY OF THE SAFETY, EFFICACY AND PHARMACOKINETICS OF ABT-263 IN COMBINATION WITH DOSE-INTENSIVE RITUXIMAB, OR DOSE INTENSIVE RITUXIMAB ALONE IN PREVIOUSLY UNTREATED PATIENTS WITH B-CELL, CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)

• IRAS ID

  54540

• Contact name

  John Gribben

• Sponsor organisation

  Abbott GmbH & Co. KG

• Eudract number

  2009-012152-24

• Clinicaltrials.gov Identifier

  NCT01087151

• Research summary

  This is a Phase II, randomised, open-label, multicentre, international study of patients with previously untreated, B-cell Chronic Lymphocytic Leukaemia (CLL). The purpose of this study is to determine whether the combination of rituximab and the study drug ABT-263 is more effective in managing CLL than rituximab alone and to determine if this combination of medicines is safe and well tolerated. Approximately 120 patients will be randomised to one of three treatment arms. Patients in Arm A will receive dose-intense, rituximab monotherapy weekly for 8 weeks; patients in Arms B will receive the same dose-intense rituximab regimen plus ABT-263 for a maximum of 12 weeks beyond the lead-in dose period; patients in Arm C will receive the same dose-intense rituximab regimen plus ABT-263 until progression of CLL or unacceptable toxicity, respectively.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  10/H0605/45

• Date of REC Opinion

  17 Sep 2010

• REC opinion

  Further Information Favourable Opinion