ASC4TARGET = Asciminib for CML-CP or CML-AP Patients With T315I Mutation [France]

What is the purpose of the study

The purpose of this study is to assess the potential of asciminib in managing patients with CML-CP or CML-CP with T315I mutation. The study also seeks to collect additional data on the effectiveness and safety of asciminib for these patients.

What will happen during the study

All patients will be given asciminib as tablets twice a day. The minimum dose to be administered in this study is 200 mg, while the maximum dose is 400 mg.

Key inclusion criteria

This study includes patients of all sexes who:

• are aged 18 years and older
• have CML in chronic phase (CP) or CML in accelerated phase (AP) with documented T315I mutation after at least one tyrosine kinase inhibitor (TKI) and are resistant, intolerant, or ineligible for treatment with ponatinib
• have not already been treated with asciminib or another allosteric inhibitor
• have failure (adapted from the 2020 & 2013 ELN Guidelines) or intolerance to ponatinib at the time of screening.

Further criteria may apply. Please discuss these with your doctor or study staff.

Key exclusion criteria

This study does not include patients who:

• have previously received treatment with a hematopoietic stem-cell transplantation
• have heart conditions as specified in the study protocol
• have severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
• have a history of clinical acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis (except if ponatinib-induced and completely resolved at time of screening)
• have a history of acute or chronic liver disease.

Further criteria may apply. Please discuss these with your doctor or study staff.

Estimated primary completion date

Where can I find additional information

You can find a study description in the US register ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health.
You can also find a study description on the EU Clinical Trials (EUCT) website. The website shows clinical trials for human medicines in the European Union (EU) and European Economic Area (EEA).

Study centers / principal investigators

France

Novartis Investigative Site
Lyon, 69373