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

Retrospective and Prospective Observational Study on the Efficacy and Tolerability of Asciminib in Real-world Clinical Practice in Patients With Chronic Myeloid Leukemia Treated in Second or Subsequent Lines: ASCIRLI (ASCIminib in Real-Life Italy)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Myeloid Leukemia; Chronic Myeloid Leukemia - Chronic Phase

Detailed Description

ASCIRLI is an observational, multicenter, retrospective and prospective study designed to 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 asciminib in third or greater line was approved in July 2023, while treatment in the other lines of therapy was approved in December 2025. Patients will be included according to these timelines. The study aims to generate comprehensive real-world evidence on the effectiveness, safety, tolerability, and health-related quality of life (HRQoL) associated with asciminib use in routine clinical practice, complementing data derived from controlled clinical trials and reflecting treatment patterns, patient characteristics, and outcomes observed in an unselected population. Treatment with asciminib will be independent from participation to this observational study and must not be initiated for the purpose of participating to this study.

Clinical data at the time of enrollment will be collected, together with previous history of resistance and/or intolerance to previous lines of treatment, including type of adverse events and mutations. Cytogenetic (eventually) and molecular responses will be collected at 3, 6,12 and subsequent follow-up according to ELN criteria.

Discontinuation and dose adjustments will be recorded. Patients will be followed according to the routine medical practice expected at least every 3-6 months.

The recruitment period is planned for 24 months from the first patient included, observation period for 36 months, with a total study duration of 60 months.

• Study Type: Observational
• Enrollment (Estimated): 98

Contacts and Locations

• Study Contact: Name: Enrico Crea; Phone Number: +390670390514; Email: e.crea@gimema.it
• Study Contact Backup: Name: Paola Fazi; Phone Number: +39 0670390528; Email: p.fazi@gimema.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

1. Patients aged ≥ 18 years and no upper age limit;
2. 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);
3. Patients treated with asciminib in second or subsequent lines of therapy (≥2L)
4. Patients who provide written informed consent to participate in the study (if applicable).

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Investigators: Principal Investigator: Massimo Breccia, Sapienza University, Rome

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: June 1, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: chronic myeloid leukemia; asciminib; second line; real-life
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Bone Marrow Diseases; Leukemia; Myeloproliferative Disorders; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase
• Other Study ID Numbers: CML1826

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No