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NCT07804901
Asciminib Frontline Risk Adapted
Conditions: Chronic Myeloid Leukemia (CML)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 200
Sponsor: Prof. Dr. med. Andreas Hochhaus
Location: Universitätsklinikum Jena Jena
Summary
This is a multi-center, prospective, non-randomized but stratified interventional phase II study of newly diagnosed CML patients in chronic phase. All patients will be treated with asciminib 80 mg QD. Patients with unfavorable risk factors will commence dasatinib 80 mg 5 days/week 4 weeks after start of asciminib. The study will be conducted in Germany.
Eligibility Criteria
Inclusion Criteria:
1. Signed informed consent must be obtained prior to participation in the trial
2. Newly diagnosed patients with BCR::ABL1+ CML-CP up to 12 weeks after diagnosis
3. Evidence of any BCR::ABL1 transcript except transcripts lacking ABL1 exon a2.
4. Male or female patients ≥ 18 years of age
5. ECOG performance status of ≤2
* Diagnosis of CML-CP (ELN 2025 criteria)
* Documented chronic phase CML will meet all the below criteria (Apperley et all 2025) with \
Source: ClinicalTrials.gov (NCT07804901). StuddyBuddy aggregates publicly available trial information.
