To learn if asciminib can help to control CML. The safety and effects of this drug will also be studied.
Adult participants age ≥18 years.
Participants must have a diagnosis of Ph-positive or BCR::ABL1 positive CML in early chronic phase (i.e., time from diagnosis ≤12 months).
Participants who received prior hydroxyurea, 1 to 2 doses of cytarabine, and/or an FDA approved TKI for <30 days are eligible.
Participants with additional chromosomal abnormalities at diagnosis (early disease) and no other criteria for accelerated phase will be eligible for this study.
Participants who have received more than 30 days of prior FDA approved TKI or more than 2 doses of cytarabine.
Had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.
Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia.
Participants who are receiving any other investigational agents.
Single group
Asciminib
DrugGiven by PO
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
Novartis Pharmaceuticals
Collaborator
