Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Chronic Phase Chronic Myelogenous Leukemia
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This trial will use a combination of asciminib 40 mg by mouth (PO) twice daily (BID) plus imatinib (maximum dose of 400 mg PO once daily) in the combination treatment phase. The BCR-ABL tyrosine kinase inhibitor (TKI) that will be used for this trial is imatinib. All eligible patients will begin asc...

This trial will use a combination of asciminib 40 mg by mouth (PO) twice daily (BID) plus imatinib (maximum dose of 400 mg PO once daily) in the combination treatment phase. The BCR-ABL tyrosine kinase inhibitor (TKI) that will be used for this trial is imatinib. All eligible patients will begin asciminib in combination with imatinib on cycle 1 day 1 of the combination phase. They will continue combination therapy for a total of 12 cycles (minimum of 12 months). Each cycle will be ~28 days. At the end of 12 cycles asciminib will be discontinued and any patient who has met the criteria for the treatment-free remission (TFR) screening phase will enter into the TFR phase. Once in the TFR phase, patients will discontinue their imatinib and be monitored off treatment. The primary endpoint of this study is the 12-month "second" TFR rate after completion of 12 cycles of combination therapy. Patients will remain in the TFR phase of the study for up to three years and will have central polymerase chain reaction (PCR) testing during the first two years. Therefore, the total duration of the subject participation trial will be approximately five years (one year on combination treatment phase plus three years in the TFR phase plus one year of long-term follow-up post TFR or early discontinuation.

Tracking Information

NCT #
NCT04838041
Collaborators
H. Jean Khoury Cure CML Consortium
Investigators
Principal Investigator: Ehab Atallah, MD Medical College of Wisconsin Study Chair: Michael J. Mauro, MD Memorial Sloan Kettering Cancer Center