Asciminib Frontline Risk Adapted

NCT07804901 | Not Yet Recruiting Phase 2

• 2 other identifiers: ARTIST2026-528103-13-00
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center, prospective, non-randomized but stratified interventional phase II study of newly diagnosed CML patients in chronic phase. All patients will be treated with asciminib 80 mg QD. Patients with unfavorable risk factors will commence dasatinib 80 mg 5 days/week 4 weeks after start of asciminib. The study will be conducted in Germany.

Conditions

Chronic Myeloid Leukemia (CML)

Outcome Measures

Primary Outcomes (1)

• Rate of MMR at 12 months

  rate of response after 12 months

  12 months after start of therapy

Study Arms (2)

asciminib 80 mg QD

ACTIVE COMPARATOR

Asciminb 80 mg QD is the usual standard of care for CML patients

Drug: Standarc of Care

Asciminib 80mg QD + Dasatinib 80mg QD (5 times a week)

EXPERIMENTAL

Patients with unfavorable risk factors will commence dasatinib 80 mg 5 days/week, 4 weeks after start of asciminib.

Drug: Dasatinib 80mg QD (5 days per week)

Interventions

Standarc of Care DRUG

Asciminib 80mg QD ist the usual standard of care therapy for CML

asciminib 80 mg QD

Dasatinib 80mg QD (5 days per week) DRUG

Patients with unfavorable risk factors will commence dasatinib 80 mg 5 days/week 4 weeks after start of asciminib.

Asciminib 80mg QD + Dasatinib 80mg QD (5 times a week)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent must be obtained prior to participation in the trial
• Newly diagnosed patients with BCR::ABL1+ CML-CP up to 12 weeks after diagnosis
• Evidence of any BCR::ABL1 transcript except transcripts lacking ABL1 exon a2.
• Male or female patients ≥ 18 years of age
• ECOG performance status of ≤2
• Diagnosis of CML-CP (ELN 2025 criteria)
• Documented chronic phase CML will meet all the below criteria (Apperley et all 2025) with \<20% blasts in PB and BM
• No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly.
• Adequate end organ function prior to randomization as defined by:
• Total bilirubin (TBL) \< 3 x ULN; participants with Gilbert's syndrome may only be included if TBL ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN
• eGFR ≥ 30 mL/min/1.73m2 as calculated using the CKD-EPI 2021 equation
• Serum lipase ≤ 1.5 x ULN. For serum lipase \> ULN - ≤ 1.5 x ULN, value must be considered not clinically significant and not associated with risk factors for acute pancreatitis
• Participants must have the following laboratory values within normal limits or corrected to within normal limits with supplements prior to randomization:
• Potassium (potassium increase of up to 6.0 mmol/L is acceptable if associated with eGFR\* ≥ 90 mL/min/1.73m2)
• Total calcium (corrected for serum albumin); (calcium increase of up to 12.5 mg/dl or 3.1 mmol/L is acceptable if associated with eGFR\* ≥ 90 mL/min/1.73m2)

You may not qualify if:

• Previous treatment for CML or any other anticancer agents including chemotherapy and/or biologic agents or prior stem cell transplant, with the exception of hydroxyurea for a maximum of 12 weeks or any TKI for a maximum of 2 weeks.
• BCR::ABL1 transcripts lacking ABL1 exon a2 (e.g., e13a3, e14a3, e1a3)
• Known cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS involvement, lumbar puncture not required)
• Impaired cardiac function or cardiac repolarization abnormality including but not limited to any one of the following:
• History of myocardial infarction, angina pectoris, coronary artery bypass graft within 6 months prior to starting study treatment.
• 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).
• QTcF ≥ 450 ms on the average of three serial baseline ECG (using the QTcF formula). If QTcF ≥ 450 ms and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTcF.
• Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
• Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia.
• Concomitant medication(s) with a "Known risk of Torsades de Pointes" per crediblemeds.org that cannot be discontinued or replaced 7 days prior to starting study treatment by safe alternative medication.
• Inability to determine the QTcF interval.
• Severe and/or uncontrolled concurrent medical disease that in the opinion of the Investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. uncontrolled diabetes mellitus, active or uncontrolled infection; uncontrolled arterial or pulmonary hypertension, uncontrolled clinically significant hyperlipidemia)
• History of significant congenital or acquired bleeding disorder unrelated to cancer.
• Major surgery within 4 weeks prior to trial entry or patients who have not recovered from prior surgery.
• History of acute pancreatitis within 1 year prior to randomization or medical history of chronic pancreatitis.

Sponsors & Collaborators

• Prof. Dr. med. Andreas Hochhaus: lead

Study Sites (1)

Universitätsklinikum Jena

Jena, 07747, Germany

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Central Study Contacts

Christian Fabisch, Dr.

CONTACT

+49 3641 939 66 70; artist@med.uni-jena.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: non-randomized but stratified; All patietns start with Asciminib, patients with standard risk factors commence in standard of Care, patients with risk factors start additional therapy with Dasatinib (in combination with Asciminib).

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 4, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): June 30, 2031
• Last Updated: September 4, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)