Efficacy of Asciminib in Real-world in Patients With Chronic Myeloid Leukemia in Second or Subsequent Lines

NCT07640750 | Not Yet Recruiting

• 1 other identifier: CML1826
• Study Type: observational
• Target: 98
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to evaluate the efficacy and tolerability of asciminib in real-life in patients with chronic myeloid leukemia treated in second or subsequent lines. The main object of the study is to assess the achievement of Major Molecular Response.

Conditions

Chronic Myeloid Leukemia; Chronic Myeloid Leukemia - Chronic Phase

Keywords

chronic myeloid leukemia; asciminib; real-life; second line

Outcome Measures

Primary Outcomes (1)

• Evaluation of response to asciminib

  Proportion of patients achieving Major Molecular Response (MMR) by RT-PCR at 24 months after the start of asciminib treatment

  24 months

Study Arms (1)

Patients with chronic myeloid leukemia treated with asciminib in the real-life

Patients with chronic phase myeloid leukemia treated in second or subsequent lines with asciminib according to clinical practice

Eligibility Criteria

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

Study Population

The study will include all adult patients with chronic-phase chronic myeloid leukemia (CML-CP) who initiated second-line or subsequent lines of therapy with asciminib after the date of its commercial availability. In detail, treatment with asciminb in third or greater line was approved in July 2023, while treatment in the other lines of therapy was approved by EMA in December 2025. Patients will be included according to these timelines.

You may qualify if:

• Patients aged ≥ 18 years and no upper age limit;
• Patients with a diagnosis of CML-CP who started treatment with asciminib according to clinical practice - from the date of commercial availability of asciminib - until the end of recruitment period (two years after the first patient included);
• Patients treated with asciminib in second or subsequent lines of therapy (≥2L)
• Patients who provide written informed consent to participate in the study (if applicable).

You may not qualify if:

• None

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase

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

Study Officials

• Massimo Breccia

  Sapienza University, Rome

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Fazi

CONTACT

+39 0670390528; p.fazi@gimema.it

Enrico Crea

CONTACT

+390670390514; e.crea@gimema.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share