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Real-World check: Asciminib's performance in Tough-to-Treat CML

NCT ID NCT07640750

Disease control Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will follow about 98 adults with chronic myeloid leukemia who are taking asciminib after other treatments have stopped working. Researchers want to see how many patients achieve a major molecular response (a key sign of disease control) after two years. The goal is to understand how effective and tolerable asciminib is in real-world settings, outside of controlled clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
asciminib
What this could lead to
If successful, this study could confirm that asciminib is a reliable option for controlling CML when other treatments have failed.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. It is also relatively small (98 participants) and not yet recruiting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 98 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic myelogenous leukemia, BCR-ABL1 positive Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic myeloid leukemia Chronic myeloid leukemia, chronic phase

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.