ASC2ESCALATE (CABL001AUS08) = Asciminib Monotherapy, With Dose Escalation, for 2nd Line Chronic Myelogenous Leukemia [United States]

What is the purpose of the study

This is a study to evaluate oral asciminib in patients with CML in chronic phase (CP) without T315I mutation who did not respond or were intolerant to 1 previous tyrosine kinase inhibitor (TKI) therapy.

What will happen during the study

This single-arm, open label trial consists of three periods: screening and baseline for up to 28 days, treatment with ascimib for up to 104 weeks and a safety follow up period for 30 days.

Patients with CML-CP without T315I mutation who have received 1 prior TKI therapy will be enrolled in this trial.

For the first 6 months of the treatment period, patients will receive oral asciminib 80 mg once a day. At six months, patients who have achieved Major Molecular Response (MMR, BCR-ABL1IS <1%) will continue on the 80 mg once a day dosage. For those who did not achieve MMR, the dosage will be increased to 200 mg once a day. At 12 months or 52 weeks, patients will either continue on 80 mg once a day, 200 mg once daily, or increase to 200 mg twice a day dependent on MMR. Investigators may also choose the patient’s dosage at 12 months.

Key inclusion criteria

This study includes patients of all sexes who:

• are aged 18 years or older
• have chronic myelogenous leukemia in chronic phase (CML-CP), no previous accelerated phase (AP) or blast crisis (BC)
• have treatment failure/resistance to first line TKI therapy and BCR-ABL1IS at screening is
  – >10% if they received first line TKI treatment for a duration between 6 and 12 months
  – >1% if they received first line TKI treatment for longer than 12 months
• have treatment intolerance to first line TKI and BCR-ABL1IS at screening is >0.1%.

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

Key exclusion criteria

This study does not include patients who:

• have been treated with 2 or more ATP-binding site TKIs
• have been treated previously with asciminib
• have known presence of a T315I mutation at any time before study entry
• have a known second chronic phase of CML after previous progression to AP/BC.

Further criteria 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 registry ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health.

Study centers / principal investigators

United States

Colorado

Rocky Mountain Cancer Centers USOR
Bolder, Colorado, 80304
Principal Investigator: David J. Andorsky

Ohio

Hematology Oncology Care
Cincinnati, Ohio, 45236
Principal Investigator: Kruti Patel

Texas

Texas Oncology P A TX Oncology Baylor
Dallas, Texas, 752521
Principal Investigator: Koji Sasaki