Stopping nilotinib treatment for CML patients
Research type
Research Study
Full title
A phase II, single arm, open label study of treatment-free remission after achieving sustained MR4.5 on nilotinib.
IRAS ID
127189
Contact name
Jennifer Byrne
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2012-003186-18
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
This study is a phase II, single arm open label study of treatment-free remission after achieving sustained Molecular response 4.5 log reduction from baseline (MR4.5) on nilotinib, The purpose of this study is to see whether it is safe to stop current treatment with nilotinib for treating Chronic Myeloid Leukaemia (CML) patients. Patients will have previously started treatment with imatinib when they were first diagnosed and then switched to nilotinib for at least 2 years and will have been treated for their CML for at least 3 years in total. Eligible patients must have the BCR-ABL protein in their blood. About 117 patients will take part in this study worldwide with their total duration in the study being approximately 5 years.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
13/WM/0140
Date of REC Opinion
24 Jun 2013
REC opinion
Further Information Favourable Opinion