100
Participants
Start Date
April 22, 2022
Primary Completion Date
February 29, 2032
Study Completion Date
February 29, 2032
Single Agent Asciminib
taken orally once a day starting cycle 1 day 1 for up to 24 months during the single agent asciminib phase. Asciminib is a potent allosteric inhibitor of BCR::ABL1.
Low TKI
"Low dose tyrosine kinase inhibitor (lowTKI) (dasatinib 50 mg daily or imatinib 300 mg daily or nilotinib 300 mg daily) at investigators discretion, may be added to asciminib in the following situations:~* Patients who have treatment failure at any time based on ELN criteria (Appendix 7)~* Patients who have a warning response after 12 months of single agent asciminib based on ELN criteria (Appendix 7)~* Patients who have not achieved MR4.5 after 24 months, but no later than 36 months, of single agent asciminib."
Elective Free Treatment
Once central eligibility has been obtained the patient should discontinue asciminib and if applicable lowTKI within 14 days.
RECRUITING
Memorial Sloan Kettering Cancer Center, New York
RECRUITING
Roswell Park Comprehensive Cancer Center, Buffalo
RECRUITING
Georgia Cancer Center at Augusta University, Augusta
RECRUITING
Karmanos Cancer Institute, Detroit
RECRUITING
Froedtert Hospital & the Medical College of Wisconsin, Milwaukee
RECRUITING
Huntsman Cancer Institute, Salt Lake City
H. Jean Khoury Cure CML Consortium
OTHER
Augusta University
OTHER