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

ClinicalTrials.gov ID: NCT05143840

Public ClinicalTrials.gov record NCT05143840. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 25, 2026, 11:37 PM EDT

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Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT05143840
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: University of Alabama at Birmingham; Other
Enrollment: 100 participants

Conditions and interventions

Conditions

Interventions

Drug · Combination Product · Other

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 22, 2022 (Actual)
Primary completion: Feb 2032 (Estimated)
Completion: Feb 2032 (Estimated)
Last update posted: Jul 22, 2026

2022 – 2032

United States locations

U.S. sites: 8
U.S. states: 6
U.S. cities: 8

Facility	City	State	ZIP	Site status
University of Alabama at Birmingham	Birmingham	Alabama	35294	—
Winship Cancer Institute Emory University	Atlanta	Georgia	30322	—
Georgia Cancer Center at Augusta University	Augusta	Georgia	30912	—
Karmanos Cancer Institute	Detroit	Michigan	48201	—
Roswell Park Comprehensive Cancer Center	Buffalo	New York	14263	—
Memorial Sloan Kettering Cancer Center	New York	New York	10065	—
Huntsman Cancer Institute	Salt Lake City	Utah	84112	—
Froedtert Hospital & the Medical College of Wisconsin	Milwaukee	Wisconsin	53226	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05143840, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 22, 2026 · Synced Oct 25, 2026

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The complete public registry record, listed eligibility criteria, and available contact information for NCT05143840 live on ClinicalTrials.gov.

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