Ask4More: Asciminib Add-on Phase II
Research type
Research Study
Full title
A phase 2, multi-center, open-label, randomized study of oral asciminib added to imatinib versus continued imatinib versus switch to nilotinib in patients with CML-CP who have been previously treated with imatinib and have not achieved deep molecular response
IRAS ID
249450
Contact name
Jane Apperley
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2018-001594-24
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 10 months, 3 days
Research summary
In 95% of subjects Chronic Myeloid Leukaemia (CML) occurs when a chromosome translocation results in the production of BCR-ABL protein, a constitutively active tyrosine kinase that causes over production of immature blood cells (leukaemia). Tyrosine Kinase Inhibitors (TKIs) have revolutionised treatment of CML resulting in overall survival close to normal life expectancy. New goals for CML patients are quality of life improvement and achieving Treatment Free Remission; patients must have achieved deep molecular response (DMR) measured as a response level of at least 4-log reduction in the production of BCR-ABL (MR4.0 International Scale). Current standard of care is treatment with TKIs, usually imatinib (400mg, once daily - QD). Patients that don’t achieve the desired molecular response on treatment with imatinib, within 2 years, may be good candidates for treatment with a new TKI, asciminib; the combination of imatinib and asciminib is expected to result in more potent inhibition of BCR-ABL1 resulting in a higher possibility of achieving DMR. This is a phase 2 study to compare efficacy and safety of treatment of CML patients with either continued treatment with imatinib (400mg QD) or treatment of imatinib and asciminib (40mg or 60mg QD), or switch to nilotinib (another TKI; 300mg twice a day). Patients must have received prior treatment with imatinib only and have achieved cytogenetic response but not MR4.0. Efficacy will be measured as patients who achieve a 4.5 log reduction in the production of BCR-ABL (MR4.5 IS) after 48 weeks of treatment. 120 patients will be randomised 1:1:1:1 and will continue on the allocated treatment until treatment failure or intolerability or up to 96 weeks. Patients in the imatinib only arm who have not achieved MR4.5 at 48 weeks will be allowed to cross over to receive 60mg QD asciminib in combination with imatinib 400mg QD.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
18/SC/0444
Date of REC Opinion
24 Sep 2018
REC opinion
Further Information Favourable Opinion