* ASC4FIRST: Asciminib vs TKI in newly diagnosed CML-CP
Research type
Research Study
Full title
A phase III, multi-center, open-label, randomized study of oral asciminib versus Investigator selected TKI in patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase
IRAS ID
299347
Contact name
Dragana Miliokovic
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2021-000678-27
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 0 months, 0 days
Research summary
Chronic myelogenous leukemia (CML) is an uncommon type of bone marrow cancer. CML occurs when there is a change to the Philadelphia chromosome and it starts creating an abnormal protein called BCR-ABL1 which causes some abnormal immature white blood cells (blasts) to grow too quickly and build up in the body crowding out the normal white blood cells that make up the immune system.
CML in the Chronic Phase (CML-CP; when the blood and bone marrow contain <10% blasts) is treated with drugs called tyrosine kinase inhibitors, which prevent the BCR-ABL1 gene producing the BCR-ABL1 protein. The most common TKI used to treat newly diagnosed CML-CP patients is imatinib. The current standard of care treatments all target a specific part of the BCR-ABL1 gene called the ATP-binding site. Asciminib is a new treatment for CML-CP which also inhibits the production of BCR-ABL1 protein but targets a different part of the BCR-ABL1 gene.
The trial purpose is assessment of whether asciminib will have better efficacy and tolerability than current standard of care TKIs in newly diagnosed CML-CP. The measurement of efficacy is whether patients will have a major molecular response (BCR-ABL1 gene is ≤0.1% after 48 weeks of treatment). This is a randomised study where patients have an equal chance of receiving asciminib or TKI. The TKI arm of the study is stratified so that half of patients receiving TKIs will receive imatinib and half will receive one of nilotinib, dasatinib or bosutinib (as decided by their study doctor). Patients will also be stratified on the Euro Long-Term Survival Score (ELTS; how well patients are expected to respond to treatment based on individual and disease characteristics). Patients will remain on study until 5 years after the last patient starts treatment.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
22/SC/0355
Date of REC Opinion
26 Oct 2021
REC opinion
Further Information Favourable Opinion