RecruitingPhase 2NCT05143840

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

Asciminib as Initial Therapy With Addition of Lower Dose Tyrosine Kinase Inhibitors for Patients With Chronic Myeloid Leukemia Who do Not Achieve Optimal Response or a Deep Molecular Remission (ALERT CML)

Sponsor

Augusta University

Enrollment

100 participants

Start Date

Apr 22, 2022

Study Type

INTERVENTIONAL

Conditions

Leukemia, Myeloid Chronic Myeloid Leukemia, Chronic Phase Leukemia,Myeloid, Chronic Adult CML

Summary

This study is a multicenter Phase 2, non-randomized, open-label single-group frontline study administering asciminib in patients with newly diagnosed Chronic Myeloid Leukemia-Chronic Phase (CML-CP). The aim of this study is to evaluate the efficacy and safety of asciminib in newly diagnosed CML-CP. Patients will receive asciminib 80 mg orally once daily during the single asciminib phase. Response is determined by PCR (polymerase chain reaction) blood test during the study. Patients who have not achieved a response after 24 months (but no later than 36 months) of single agent asciminib will be offered the addition of a low dose tyrosine kinase inhibitor (low-TKI) namely dasatinib, imatinib, or nilotinib at the investigator's discretion. The following doses of the TKIs will be used: 1. Dasatinib 50 mg daily 2. Imatinib 300 mg daily 3. Nilotinib 300 mg daily Patients will discontinue study treatment if they experience disease progression, or unacceptable toxicity.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing asciminib, a newer targeted medication, as an initial treatment for people with newly diagnosed chronic myeloid leukemia (CML) — a type of blood cancer. Asciminib works differently from older CML drugs and may have fewer side effects. **You may be eligible if...** - You are 18 or older and recently diagnosed with CML (within the last 6 months) - Your CML is in the chronic phase (not advanced/blast phase) - You have taken little to no prior CML medication (30 days or less of a targeted therapy) - Your heart, kidney, liver, and blood counts are in acceptable ranges - You are able to use effective contraception during and after treatment **You may NOT be eligible if...** - Your CML has progressed to an accelerated or blast phase - You have a history of pancreatitis (within the last 12 months) - You have had a heart attack, major heart rhythm problem, or coronary artery bypass surgery recently - You have previously been treated with asciminib - You have a known active hepatitis B infection - 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

DRUGSingle 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_PRODUCTLow 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.

OTHERElective Free Treatment

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