AsterA: Treatment-free Remission in Chronic Phase CML [Korea]

What is the purpose of the study

This is a study to assess if adding asciminib to tyrosine kinase inhibitors (TKI) can help patients in chronic phase chronic myeloid leukemia (CP CML) achieve treatment-free remission (TFR) who relapsed after a first attempt to stop treatment.

Key inclusion criteria

This study includes patients of all sexes who:

• are aged 19 years or older.
• have been diagnosed with chronic phase chronic myeloid leukemia (CP CML).
• have been taking TKIs (imatinib, nilotinib or dasatinib) for 5 years or more.
• have regained MR3.0 or deeper molecular response after restarting TKIs following an unsuccesful attempt to stop treatment.
• have been taking TKIs for 12 weeks to restart TKI treatment after an unsuccesful attempt to stop treatment.

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

Key exclusion criteria

This study does not include patients who:

• experienced grade 3 or higher adverse events with TKIs (imatinib, dasatinib, and nilotinib).
• are receiving any other investigational agents.
• currently have uncontrolled infections.
• have previously received Chimeric antigen receptor T-cell (CAR-T cell) therapy, allogeneic hematopoietic stem cell transplantation (allo-HSCT) or biologic therapy.
• have clinically significant cardiovascular disease or gastrointestinal dysfunction.
• have had thromboembolic episodes in the 3 months before entering the study.

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.

Study centers / principal investigators

South Korea

Gachon University Gil Medical Center
Incheon, 21565
Contact: Eunju Park