Brief Summary
The purpose of this trial is to assess efficacy of an induction phase of combination therapy with asciminib plus low dosethe amount of medication taken dasatinib in newly diagnosed chronica long-lasting disease that changes slowly over time phase CML (CP-CML) with high-risk genetics, with respect to achievement of major and deep molecular response.
CML14 (ASCENDANCE) is a successor trial to the ALLG-sponsored CML13 (ASCEND-CML, ACTRN12620000851965). CML14 aims to further improve outcomes through the use of our NGS panel to identify AGAs, and offer these patients with AGAs frontline treatment with combination asciminib / dasatinib therapy.
Intervention/Treatment
- Drug: Asciminib.
- Drug: Dasatinib.
Inclusion Criteria
- Newly diagnosed Ph-positive Chronic Phase (CP)-CML patients aged 18 or older.
- No prior (Tyrosine Kinase Inhibitor) TKI exposure of more than 14 days. (Hydroxyurea, anagrelide, leukapheresisa procedure used to quickly reduce dangerously high levels of white blood cells to a safer level allowed prior, and up to 1 week after starting study treatment).
- Must be 6 months or less from diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results to screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening.
- Must have e13a2 (b2a2) and/or e14a2 (b3a2) or e1a2 transcript on screening.
- Must have bone marrowsoft, spongy tissue found in bones that makes blood cells aspirateto draw out fluid or tissue from the body, often with a syringe confirming chronic phase as per ELN (not WHO) criteria. Additional cytogenetic abnormalities at baseline or diagnosis do not classify a patient as accelerated phase for the purpose of this study.
- Willingly provide informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. and agree to comply with study protocol.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status 0-2.
- Based on known medical history, expected to have a life expectancy of 12 months or more.
- Eligible for a reimbursed treatment with imatinib or dasatinib under the Pharmaceutical Benefit Scheme (PBS) complex drug program in Australia, the Pharmac system in New Zealand or through other arrangements with regulatory and funding authorities (compassionate supply or hospital funded supply).