* Asciminib evaluation in previously treated CML patients
Research type
Research Study
Full title
A phase 3b, multi-center, open-label, treatment optimization study of oral asciminib in patients with Chronic Myelogenous Leukemia in chronic phase (CML-CP) previously treated with 2 or more tyrosine kinase inhibitors
IRAS ID
302263
Contact name
Dr Dragana Milojkovic
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2020-006057-21
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, months, days
Research summary
Chronic myeloid leukemia (CML) is a type of cancer that starts in certain blood-forming cells of the bone marrow. In the majority of subjects 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). If untreated, the disease progresses from an initial chronic phase (duration about 3 to 5 years) to an accelerated phase (of shorter duration) to a fatal blast (abnormal white blood cell) crisis, the terminal phase of CML. Tyrosine Kinase Inhibitors (TKI’s) have revolutionised treatment of CML resulting in overall survival close to normal life expectancy.
The purpose of the study is to optimise the treatment of asciminib in patients with CML in chronic phase (CML-CP) previously treated with 2 or more TKI’s. The study will investigate the use of two different doses. Patients will be randomized to either receive asciminib 40 mg twice a day or of 80 mg once a day. In patients not achieving Major Molecular Response (MMR) at 48 weeks, or losing the response after the week 48 assessment up to week 108, the asciminib dose may be escalated to 200mg once a day.
The trial will enrol a total of approximately 186 patients:
• 156 patients with CML-CP who were treated with two or more TKIs and who were either resistant or intolerant to the last treatment. Intolerant patients must not have achieved MMR at baseline visit. For this population, the primary endpoint for MMR at 48 weeks will be assessed.• Up to 30 additional patients intolerant only to their last TKI treatment and in MMR at baseline will also be enrolled. This patient population will not be part of primary endpoint analysis, but they will still complete all study assessments.
REC name
North West - Haydock Research Ethics Committee
REC reference
22/NW/0248
Date of REC Opinion
24 Sep 2021
REC opinion
Further Information Favourable Opinion