Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase

PHASE2RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

April 22, 2022

Primary Completion Date

February 29, 2032

Study Completion Date

February 29, 2032

Conditions
Chronic Myeloid Leukemia, Chronic PhaseAdult CMLLeukemia, MyeloidLeukemia,Myeloid, Chronic
Interventions
DRUG

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.

COMBINATION_PRODUCT

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."

OTHER

Elective Free Treatment

Once central eligibility has been obtained the patient should discontinue asciminib and if applicable lowTKI within 14 days.

Trial Locations (6)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

14263

RECRUITING

Roswell Park Comprehensive Cancer Center, Buffalo

30912

RECRUITING

Georgia Cancer Center at Augusta University, Augusta

48201

RECRUITING

Karmanos Cancer Institute, Detroit

53226

RECRUITING

Froedtert Hospital & the Medical College of Wisconsin, Milwaukee

84112

RECRUITING

Huntsman Cancer Institute, Salt Lake City

All Listed Sponsors
collaborator

H. Jean Khoury Cure CML Consortium

OTHER

lead

Augusta University

OTHER