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Asciminib Frontline Risk Adapted

NCT07804901 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-09-04

No results posted yet for this study

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)

Interventions

DRUG

Dasatinib 80mg QD (5 days per week)

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

DRUG

Standarc of Care

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

Sponsors & Collaborators

  • Prof. Dr. med. Andreas Hochhaus

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-01
Primary Completion
2030-12-31
Completion
2031-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07804901 on ClinicalTrials.gov