Bosutinib vs Imatinib in Newly Diagnosed CML
Research type
Research Study
Full title
A Multicenter Phase 3 Randomized Open-Label Study of Bosutinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia.
IRAS ID
149876
Contact name
Jennifer Byrne
Contact email
Sponsor organisation
Pfizer Limited
Eudract number
2013-005101-31
Clinicaltrials.gov Identifier
Research summary
This study will assess the safety and efficacy of bosutinib, a drug currently approved to treat patients with Chronic Myelogenous Leukemia (CML) who have been previously treated, compared to the current standard therapy imatinib in patients with newly diagnosed CML This study will investigate the use of bosutinib as a first treatment for patients with CML. A previous study conducted comparing the same drugs in CML patients showed their efficacy to be similar but with distinct safety profiles. It is felt that some aspects of the design of that trial contributed to bosutinib not being found to be superior, namely choice and timing of the primary endpoint and also management of the side effect profile of bosutinib. This study is being conducted with actions taken to address these issues. This study is important as it will confirm whether or not bosutinib is superior to imatinib and if it is found to be then may lead to the approval of bosutinib for patients with newly diagnosed CML and provide an additional important drug option in the treatment of CML.
Study patients will be randomly assigned to take bosutinib or imatinib and both patient and doctor will know what drug they are taking. Patients will take the assigned drug once a day for the duration of the study. Over the course of the trial they would visit the hospital for a total of 22 visits over 5 years (10 visits in year one, 4 visits in year two, 4 visits in year three, 2 visits in year four and 2 visits in year 5). The primary endpoint of the study is Major Molecular Response at 12 months, an important prognostic factor in patient survival and control of CML.
REC name
London - Riverside Research Ethics Committee
REC reference
14/LO/1192
Date of REC Opinion
16 Jul 2014
REC opinion
Favourable Opinion