Frontline Asciminib Combination in Chronic Phase CML
Status:
Recruiting
Trial end date:
2027-12-01
Target enrollment:
Participant gender:
Summary
Adult male and female patients with newly diagnosed Philadelphia chromosome positive (Ph+)
and/or BCR-ABL1 positive CML can be included in the study until 3 months after diagnosis. A
<4 week pretreatment with hydroxyurea is permitted. Patients treated for <6 weeks with
nilotinib 300 mg BID, imatinib 400 mg QD, dasatinib 100 mg QD or without any therapy are
eligible for recruitment and will be allocated to the respective cohort. All patients must
provide written informed consent to be enrolled in the trial. Cohorts were designed to allow
assessment of QD and BID asciminib based combinations to optimize quality of life and
compliance. Patients will not be randomized. In general, cohorts will be filled
consecutively. Asciminib therapy will be commenced 12 weeks after start of nilotinib,
imatinib or dasatinib and after recovery of hematopoiesis or in case of no therapy so far 6
weeks after diagnosis as first line treatment. Referred patients already treated with
imatinib, nilotinib or dasatinib will remain on the initial drug and will be allocated to the
respective cohort.
Phase:
Phase 2
Details
Lead Sponsor:
Prof. Dr. med. Andreas Hochhaus University of Jena
Collaborators:
Ludwig-Maximilians - University of Munich Novartis Pharmaceuticals