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New hope for leukemia patients: asciminib study launches in china

NCT ID NCT07375355

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at how well and how safely the drug asciminib works for people newly diagnosed with a type of leukemia called chronic myeloid leukemia (CML). About 200 adults in China will take the drug and be followed for at least 12 months. The main goal is to see how many achieve a deep reduction in cancer cells.

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 200 people

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

Started

Feb 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

patients newly diagnosed with CML-CP and confirmed with Ph+ CML in medical records

Ages

18 to 99 years

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: Patients eligible for inclusion in this study must meet all the following criteria: 1. 18 years or older at the time of ICF signing; 2. Newly diagnosed with Ph+ CML-CP within 3 months before enrollment; \- The diagnosis documentation must include the type and quantitative level of the BCR-ABL1 transcript. 3. Prior treatment with a maximum of 2 weeks of TKIs; 4. Prior treatment with non-TKI regimens, including interferon and hydroxyurea, is allowed; 5. Patients scheduled to initiate treatment with asciminib; \- Patients beginning asciminib treatment must receive the first dose within 14 days of signing the ICF; 6. Signed ICF. Exclusion Criteria: Patients meeting any of the following criteria are not eligible for inclusion in this study: 1. Previous diagnosis of CML-accelerated phase or blast crisis; 2. Currently participating in an interventional clinical study for CML; 3. Having rare, atypical transcript types that cannot be standardised internationally; 4. Women who are pregnant, lactating or planning to become pregnant during the study; 5. Concurrent other malignancies (refer to the International ICD-11 diagnosis codes, with diagnostic text including carcinoma, malignant neoplasm, etc.); 6. Other conditions that are considered not suitable for the study by the investigator.

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Conditions

The condition(s) this trial relates to.

chronic myelogenous leukemia, BCR-ABL1 positive

As listed by the trial registrant

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

Chronic myeloid leukemia in chronic phase

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Novartis Investigative Site

    RECRUITING

    Wuhan, Hubei, 430022, China

More trials for these conditions

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