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All eligible patients will begin a combination of asciminib in combination with a TKI cycle 1 day 1 in the combination treatment phase. They will continue combination therapy for a total of 12 cycles (minimum of 12 months). 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 TKI and be monitored off treatment.

40 mg by mouth (PO) when used with imatinib.

Asciminib 40 MG

40 mg twice daily when used with nilotinib.

Asciminib 40 MG Twice Daily

Asciminib 80 MG daily

Imatinib

Medical College of Wisconsin Cancer Center Clinical Trials Office

Ehab Atallah, MD

Sharon Prokop

Jay Yang, MD

Michael Mauro, MD

Srinivas Tantravahi, MBBS

Michael J. Mauro, MD

This is a single arm phase II study that will enroll a minimum of 47 subjects with a maximum of 51. All patients will have a confirmed diagnosis of chronic phase chronic myeloid Leukemia and must have previously attempted to discontinue Tyrosine Kinase inhibitors (TKI). All patients must have restarted the same TKI they were on prior to discontinuation at the time of relapse in order to be eligible for this trial.

All eligible patients will begin asciminib in combination with a TKI 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 also discontinue their TKI 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 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.

Protocol Number: HJKC3-0003. Treatment Free Remission After Combination Therapy With Asciminib (ABL001) Plus Tyrosine Kinase Inhibitors (TKI) in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation

This will be measured by the number of subjects who achieve one-year treatment-free remission after 12 months of combination therapy with TKI plus asciminib. These subjects have previously failed a first treatment free remission attempt.

H. Jean Khoury Cure CML Consortium

Medical College of Wisconsin

Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Protocol Number: HJKC3-0003. Treatment Free Remission After Combination Therapy With Asciminib (ABL001) Plus Tyrosine Kinase Inhibitors (TKI) in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation	NCT04838041	Chronic Phase C...	Asciminib 40 MG Asciminib 40 MG... Asciminib 80 MG... Imatinib Nilotinib Dasatinib	18 Years -	Medical College of Wisconsin
Protocol Number: HJKC3-0003. Treatment Free Remission After Combination Therapy With Asciminib (ABL001) Plus Tyrosine Kinase Inhibitors (TKI) in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation	NCT04838041	Chronic Phase C...	Asciminib 40 MG Asciminib 40 MG... Asciminib 80 MG... Imatinib Nilotinib Dasatinib	18 Years -	Medical College of Wisconsin

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