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NCT05143840

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

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Alabama at Birmingham
~100 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:Single Agent AsciminibLow TKIElective Free Treatment

At a glance

Recruiting sites
0 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Outcome Measure 1: Deep Molecular Response
Measured over 24 months
+1 more outcome measured

Conditions

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

Explore related trials

Chronic Myeloid Leukemia, BCR-ABL1 PositiveBCR/ABL1 Fusion Gene

Where it's being run

8 sites across 6 states
Georgia2
New York2
Alabama1
Michigan1
Utah1
Wisconsin1

Study leadership

  • Jorge S Cortes, MD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

AST and ALT \< 3 times the institutional upper limit of normal (ULN)
eGFR ≥ 30 mL/min as calculated using the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine equation (https://www.kidney.org/professionals/kdoqi/gfr\_calculator)
Total bilirubin \< 1.5 times the institutional ULN or \< 3.0 x the institutional ULN with Gilbert Syndrome (unless direct bilirubin is within normal limits) 7. Adequately controlled blood pressure, defined as systolic blood pressure of \<140 mmHq and diastolic of \<90 mmHg, at the time of enrollment. 8. Lipase ≤ 1.5 x ULN. For lipase \> ULN - ≤ 1.5 x ULN, value should be considered not clinically significant and not associated with risk factors for acute pancreatitis. 9. Creatine phosphokinase \< 2.5 x ULN 10. Female patients must meet one of the following:

What this trial measures

  • Primary Outcome Measure 1: Deep Molecular Response24 months

    The proportion of patients achieving BCR::ABL1 \<0.01% IS (MR4.0) within 12 months of treatment with single agent asciminib

  • Digital Droplet PCR2 years

    Digital droplet PCR (ddPCR). Our Consortium work in the LAST study showed that ddPCR is more sensitive than conventional PCR and is very important in predicting TFR in detecting BCR::ABL1 in cases without detectable disease by conventional PCR29. Thus, samples taken for BCR::ABL1 monitoring in this trial will also be tested by ddPCR using the Bio-Rad platform. This will allow for a head to head comparison of these two methods.