RecruitingPhase 2NCT04838041

Protocol Number: HJKC3-0003. Treatment Free Remission After Asciminib Based Therapy in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation


Sponsor

Medical College of Wisconsin

Enrollment

51 participants

Start Date

Nov 11, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether patients with chronic myeloid leukemia (CML) — a type of blood cancer — can safely stop taking their leukemia medication (a TKI) a second time after previously failing a first attempt, especially when using a newer drug called asciminib to help achieve deeper remission first. **You may be eligible if:** - You are 18 or older with CML in the chronic (stable) phase - You previously attempted to stop your leukemia medication once before and the cancer came back - You were retreated and have now reached a very deep remission (very low to undetectable cancer levels in the blood) - You have been on a TKI medication such as imatinib, dasatinib, or nilotinib - You have adequate kidney, liver, and blood counts **You may NOT be eligible if:** - Your CML has ever been in a more aggressive phase (accelerated or blast phase) - You have a history of pancreatitis in the past year - You have previously been treated with asciminib - You have had a prior stem cell transplant - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAsciminib 40 MG

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

DRUGAsciminib 40 MG Twice Daily

40 mg twice daily when used with nilotinib.

DRUGAsciminib 80 MG daily

80 mg daily when used with dasatinib or taken alone.

DRUGImatinib

Maximum dose of 400 mg PO once daily.

DRUGNilotinib

Maximum dose of 300 mg twice daily.

DRUGDasatinib

Maximum dose of 100 mg PO once daily.


Locations(4)

The Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT04838041


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