Asciminib versus Bositunib in Chronic Myeloid Leukaemai
Research type
Research Study
Full title
A phase 3, multi-centre open-label randomised study oforal ABL001 versus bosutinib in patients with Chronic Myelogenous Leukemia in chronic phase (CML-CP), previously treated with 2 or more tyrosine kinase inhibitors
IRAS ID
229242
Contact name
Adam Mead
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Limited
Eudract number
2016-002461-66
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 1 months, 17 days
Research summary
The purpose of this pivotal study is to compare the efficacy of ABL001 with that of
bosutinib in the treatment of patients with CML-CP who have previously been treated
with a minimum of two prior ATP-binding site TKIs with BCR-ABL ratios ≥ 1% IS at
screening.There remains an unmet need for new compounds in patients with CML who have
failed at least two prior TKIs. Current practice suggests that a second generation
TKI will have been used for first line therapy for about one half of patients with
CML, meaning that most patients who have failed at least two prior TKIs will have
failed at least one if not two second generation TKIs: dasatinib and/or nilotinib.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
17/EM/0338
Date of REC Opinion
26 Sep 2017
REC opinion
Further Information Favourable Opinion