An observational study in Chronic Myeloid Leukemia and Chronic Myeloid Leukemia - Chronic Phase, sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto · Observational
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.
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.
894 studies on the registry are indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive; 109 are open to participants now.
This study's planned enrollment of 98 is below the median of 141 across 147 observational studies indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive.
Browse Leukemia, Myelogenous, Chronic, BCR-ABL Positive studies →Gruppo Italiano Malattie EMatologiche dell'Adulto is the lead sponsor of 135 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with chronic phase myeloid leukemia treated in second or subsequent lines with asciminib according to clinical practice
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
Time frame: 24 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Leukemia, Myelogenous, Chronic, BCR-ABL Positive →
Gruppo Italiano Malattie EMatologiche dell'Adulto →