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Using asciminib as the first treatment for patients with chronic myeloid leukemia

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)

Phase 2 Interventional Augusta University · NCT05143840

This study is testing if a new medication called asciminib can be an effective first treatment for people newly diagnosed with chronic myeloid leukemia.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment100 (estimated)
Ages18 Years and up
SexAll
SponsorAugusta University Academic / other
Drugs / interventionsasciminib, chemotherapy, dasatinib, imatinib, nilotinib
Locations7 sites (Atlanta, Georgia and 6 other locations)
Trial IDNCT05143840 on ClinicalTrials.gov

What this trial studies

This multicenter Phase 2 study evaluates the efficacy and safety of asciminib in patients newly diagnosed with Chronic Myeloid Leukemia in chronic phase. Participants will receive asciminib 80 mg orally once daily, with response monitored through PCR blood tests. If patients do not achieve a response after 24 to 36 months, they may be offered a low dose tyrosine kinase inhibitor at the investigator's discretion. The study aims to determine the proportion of patients achieving a specific molecular response and to assess the safety profile of asciminib.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have been newly diagnosed with chronic phase CML within the last 6 months.

Not a fit: Patients with advanced stages of CML or those who have previously received extensive TKI therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with chronic myeloid leukemia by enhancing molecular response rates.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific use of asciminib in newly diagnosed patients is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age ≥18 years old
2. Willing and able to give informed consent
3. Newly diagnosed with CML in chronic phase within 6 months from confirmed diagnosis via bone marrow biopsy/aspirate and have either the b3a2 (e14a2) or b2a2 (e13a2) variants that give rise to the p210 BCR::ABL1 protein. Subtype classification whether b3a2 (e14a2) or b2a2 (e13a2) is not required for study eligibility.
4. Minimal prior CML therapy with a TKI for less than or equal to 30 days. Treatment with hydroxyurea, busulfan, anagrelide or other non-specific chemotherapy agents is allowed with no time restrictions within the eligible time from diagnosis.
5. ECOG performance status 0-2 (appendix 1)
6. Adequate organ function:

   * 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:

    1. Postmenopausal for at least one year before the screening visit,
    2. Surgically sterile
    3. If they are of childbearing potential, agree to practice two effective methods of contraception from the time of signing of the informed consent form through 90 days after the last dose of study drug,
    4. Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable
    5. Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, postovulation methods\] and withdrawal are not acceptable contraception methods.)
11. Male patients, even if surgically sterilized (i.e., status post vasectomy), must agree to one of the following:

    1. Practice effective barrier contraception during the entire study treatment period and through 90 days after the last study drug dose
    2. Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable
    3. Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, postovulation methods\] and withdrawal are not acceptable methods of contraception.)

Exclusion Criteria:

1. Patients with accelerated or blast phase CML (refer to appendix 4)
2. Active second malignancy requiring active treatment
3. History of recent (within 12 months) acute pancreatitis or chronic pancreatitis
4. Subjects who have previously received treatment with asciminib.
5. Subjects with PLT count \< 50,000 mm3 or ANC of \< 500 mm3 or Hemoglobin \< 8 g/dL
6. Cardiac or cardiac repolarization abnormality, including any of the following:

   1. History within 6 months prior to starting study treatment of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG)
   2. Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block)
   3. QTcF at screening greater than or equal to 450 msec (male patients), greater than or equal to 460 msec (female patients) unless patient has a pacemaker
   4. Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:

   i. Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia ii. Concomitant medication(s) with a "Known risk of Torsades de Pointes" per wwwcrediblemeds.org/ that cannot be discontinued or replace 7 days prior to starting study drug by safe alternative medication.

   iii. Inability to determine the QTcF interval
7. Pregnant or lactating
8. Taking a strong inhibitors or inducers of CYP3A4 or CYP3A4 substrates with narrow therapeutic index (refer to appendix 6) at time of enrollment
9. Unable to comply with lab appointment schedule and PRO assessments
10. Another investigational drug within 4 weeks of enrollment
11. Any serious medical or psychiatric illness that could, in the investigator's opinion, interfere with the completion of treatment according to this protocol
12. Patient has undergone a prior allogeneic stem cell transplant
13. Known clinical history of active HBV infection

Where this trial is running

Atlanta, Georgia and 6 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Myeloid Leukemia, Chronic PhaseAdult CMLLeukemia, MyeloidLeukemia,Myeloid, ChronicChronic Myeloid Leukemiatyrosine kinase inhibitorsH. Jean Khoury Cure CML ConsortiumHJKC3-0004
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.