Chronic Myeloid LeukemiaASCIRLINCT07640750
Efficacy of Asciminib in Real-world in Patients With Chronic Myeloid Leukemia in Second or Subsequent Lines
An observational study of Chronic Myeloid Leukemia and Chronic Myeloid Leukemia - Chronic Phase, run by Gruppo Italiano Malattie EMatologiche dell'Adulto.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia, Chronic Myeloid Leukemia - Chronic Phase
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- None
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Keywords
- chronic myeloid leukemia, asciminib, real-life, second line
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2031 (estimated)
- Study completion1 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Massimo Breccia, Principal investigator, Sapienza University, Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640750
- Sponsor's protocol ID
- CML1826
- Acronym
- ASCIRLI
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07640750
- Acronym / sponsor ID
- ASCIRLI / CML1826
- Keywords
- chronic myeloid leukemia, asciminib, real-life, second line
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2031 (estimated)
- Study completion
- 1 Dec 2031 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of response to asciminib
Time frame: 24 months
Proportion of patients achieving Major Molecular Response (MMR) by RT-PCR at 24 months after the start of asciminib treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Massimo Breccia principal investigator
Sapienza University, Rome
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukemia and Chronic Myeloid Leukemia - Chronic Phase, run by Gruppo Italiano Malattie EMatologiche dell'Adulto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paola Fazi (+39 0670390528, p.fazi@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of response to asciminib (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.