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

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)

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07640750

Acronym

ASCIRLI

Enrollment

Registered

2026-06-11

Start date

2026-09-01

Completion date

2031-12-01

Last updated

2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myeloid Leukemia, Chronic Myeloid Leukemia - Chronic Phase

Keywords

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

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.

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of response to asciminib	24 months	Proportion of patients achieving Major Molecular Response (MMR) by RT-PCR at 24 months after the start of asciminib treatment

Contacts

CONTACTPaola Fazi

p.fazi@gimema.it+39 0670390528

CONTACTEnrico Crea

e.crea@gimema.it+390670390514

PRINCIPAL_INVESTIGATORMassimo Breccia

Sapienza University, Rome

Outcome results