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New CML drug asciminib under Real-World study

NCT ID NCT07549516

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Updated 8 times

Summary

This study is watching how well asciminib works and how safe it is in adults with a type of blood cancer called chronic myeloid leukemia. It includes people who are newly diagnosed or have already tried one other treatment. The main goal is to see how many patients reach a very low level of cancer cells after 12 months.

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 380 people

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

Started

Apr 2026

Expected to finish

Sep 2030

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

Adult Ph+ CML-CP patients, either newly diagnosed or previously treated with one ATP-competitive TKI, who initiate TKI treatment as recommended by the treating physician in a hematology center in Germany.

Ages

18 to 100 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: 1. Written informed consent must be obtained before participation in the study/prior to any study-related documentation. 2. Adult patients (≥18 years of age) with a confirmed diagnosis of Ph+ CML-CP. The presence of the Philadelphia chromosome may alternatively be confirmed by molecular detection of a BCR::ABL1 fusion gene/transcript (e.g., by reverse transcription polymerase chain reaction (RT-PCR)), in accordance with the World Health Organization (WHO) 2022 classification. 3. Patients who are either newly diagnosed or have received treatment with exactly one prior TKI. Prior TKI treatment is only permitted for patients in the Asciminib Cohort. Patients in the comparator cohorts (imatinib, dasatinib, bosutinib, nilotinib) must be newly diagnosed and must not have received any prior TKI treatment. 4. Patients for whom the treating physician has made a clinical decision to initiate treatment with asciminib or another TKI (imatinib, dasatinib, bosutinib, nilotinib) as part of routine care. The clinical decision for treatment must have been made prior to enrollment. Treatment must not have started more than 14 days before study inclusion, and treatment may also begin after baseline assessment. 5. Patients willing to participate in routine follow-up visits and complete patient-reported outcome questionnaires over the course of the study. Exclusion criteria: 1. Patients with contraindications to their respective chronic myeloid leukemia (CML) treatment as per the applicable Summary of Product Characteristics (SmPC) and relevant national treatment guidelines (e.g. Onkopedia CML), as well as additional disease- or treatment-related characteristics associated with distinct clinical scenarios that differ from the intended study population, including situations with specific treatment requirements or limited comparability, in which reliable interpretation of study outcomes may not be feasible, including the following asciminib specific considerations: * In first- or second-line treatment: presence of BCR::ABL1 fusion transcripts lacking exon a2 (e.g. e13a3, e14a3, e1a3). * In second-line treatment: * known BCR::ABL1 mutations associated with partial or complete resistance to asciminib (e.g. M244V, F359I/V/C). * presence of the BCR::ABL1 T315I mutation, regardless of eligibility for treatment according to SmPC (e.g., specific indication and dosing regimens). 2. Patients receiving or planned to receive asciminib or other TKIs outside the approved label (off-label use), including use in unapproved dosing regimens or frequency not covered by the respective SmPC. 3. Patients currently participating in an interventional clinical trial. 4. Patients unable or unwilling to provide written informed consent. 5. Patients who are unable to reliably complete patient-reported outcome questionnaires due to cognitive or language limitations relevant to the study assessments. 6. Patients for whom long-term follow-up is not feasible due to expected relocation or other logistical constraints. 7. The restriction to a maximum of one prior ATP-competitive TKI applies exclusively to patients treated with asciminib. Patients in the comparator cohorts (imatinib, dasatinib, bosutinib, nilotinib) must be TKI-naïve and are included at the start of their first-line TKI therapy and are not eligible if they have received any prior TKI treatment.

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Conditions

The condition(s) this trial relates to.

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

As listed by the trial registrant

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

Leukemia, chronic myeloid

How to take part

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

  1. The places running it

    65 sites. 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

    Baden-Baden, Baden-Wurttemberg, 76532, Germany

  • Novartis Investigative Site

    RECRUITING

    Heidenheim, Baden-Wurttemberg, 89522, Germany

  • Novartis Investigative Site

    RECRUITING

    Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany

  • Novartis Investigative Site

    RECRUITING

    Winnenden, Baden-Wurttemberg, 71364, Germany

  • Novartis Investigative Site

    RECRUITING

    Aschaffenburg, Bavaria, 63739, Germany

  • Novartis Investigative Site

    RECRUITING

    Augsburg, Bavaria, 86152, Germany

  • Novartis Investigative Site

    RECRUITING

    Donauwörth, Bavaria, 86609, Germany

  • Novartis Investigative Site

    RECRUITING

    Herrsching am Ammersee, Bavaria, 82211, Germany

  • Novartis Investigative Site

    RECRUITING

    Kempten (Allgäu), Bavaria, 87439, Germany

  • Novartis Investigative Site

    RECRUITING

    Landsberg am Lech, Bavaria, 86899, Germany

  • Novartis Investigative Site

    RECRUITING

    Munich, Bavaria, 81241, Germany

  • Novartis Investigative Site

    RECRUITING

    Regensburg, Bavaria, 93053, Germany

  • Novartis Investigative Site

    RECRUITING

    Bremerhaven, Free Hanseatic City of Bremen, 27576, Germany

  • Novartis Investigative Site

    RECRUITING

    Kassel, Hesse, 34125, Germany

  • Novartis Investigative Site

    RECRUITING

    Offenbach, Hesse, 63065, Germany

  • Novartis Investigative Site

    RECRUITING

    Goslar, Lower Saxony, 38642, Germany

  • Novartis Investigative Site

    RECRUITING

    Rotenburg (Wümme), Lower Saxony, 27356, Germany

  • Novartis Investigative Site

    RECRUITING

    Twistringen, Lower Saxony, 27239, Germany

  • Novartis Investigative Site

    RECRUITING

    Cologne, North Rhine-Westphalia, 50674, Germany

  • Novartis Investigative Site

    RECRUITING

    Cologne, North Rhine-Westphalia, 50677, Germany

  • Novartis Investigative Site

    RECRUITING

    Solingen, North Rhine-Westphalia, 42653, Germany

  • Novartis Investigative Site

    RECRUITING

    Wesel, North Rhine-Westphalia, 46483, Germany

  • Novartis Investigative Site

    RECRUITING

    Zittau, Saxony, 02763, Germany

  • Novartis Investigative Site

    RECRUITING

    Merseburg, Saxony-Anhalt, 06217, Germany

  • Novartis Investigative Site

    RECRUITING

    Oldenburg in Holstein, Schleswig-Holstein, 23758, Germany

  • Novartis Investigative Site

    RECRUITING

    Berlin, State of Berlin, 10365, Germany

  • Novartis Investigative Site

    RECRUITING

    Saalfeld, Thuringia, 07318, Germany

  • Novartis Investigative Site

    RECRUITING

    Bad Friedrichshall, 74177, Germany

  • Novartis Investigative Site

    RECRUITING

    Bad Liebenwerda, 04924, Germany

  • Novartis Investigative Site

    RECRUITING

    Berlin, 10437, Germany

  • Novartis Investigative Site

    RECRUITING

    Berlin, 10559, Germany

  • Novartis Investigative Site

    RECRUITING

    Berlin, 12487, Germany

  • Novartis Investigative Site

    RECRUITING

    Berlin, 12552, Germany

  • Novartis Investigative Site

    RECRUITING

    Bremerhaven, 27568, Germany

  • Novartis Investigative Site

    RECRUITING

    Buchholz Nordheide, 21244, Germany

  • Novartis Investigative Site

    RECRUITING

    Cottbus, 03046, Germany

  • Novartis Investigative Site

    RECRUITING

    Detmold, 32756, Germany

  • Novartis Investigative Site

    RECRUITING

    Dorfen, 84405, Germany

  • Novartis Investigative Site

    RECRUITING

    Dortmund, 44263, Germany

  • Novartis Investigative Site

    RECRUITING

    Dresden, 01127, Germany

  • Novartis Investigative Site

    RECRUITING

    Dresden, 01307, Germany

  • Novartis Investigative Site

    RECRUITING

    Düren, 52353, Germany

  • Novartis Investigative Site

    RECRUITING

    Erfurt, 99085, Germany

  • Novartis Investigative Site

    RECRUITING

    Eschweiler, 52249, Germany

  • Novartis Investigative Site

    RECRUITING

    Göttingen, 37073, Germany

  • Novartis Investigative Site

    RECRUITING

    Hanover, 30161, Germany

  • Novartis Investigative Site

    RECRUITING

    Hanover, 30625, Germany

  • Novartis Investigative Site

    RECRUITING

    Hildesheim, 31135, Germany

  • Novartis Investigative Site

    RECRUITING

    Kiel, 24105, Germany

  • Novartis Investigative Site

    RECRUITING

    Leipzig, 04103, Germany

  • Novartis Investigative Site

    RECRUITING

    Leverkusen, 51375, Germany

  • Novartis Investigative Site

    RECRUITING

    Mutlangen, 73557, Germany

  • Novartis Investigative Site

    RECRUITING

    Naunhof, 04683, Germany

  • Novartis Investigative Site

    RECRUITING

    Neuss, 41462, Germany

  • Novartis Investigative Site

    RECRUITING

    Offenburg, 77654, Germany

  • Novartis Investigative Site

    RECRUITING

    Oldenburg, 26121, Germany

  • Novartis Investigative Site

    RECRUITING

    Parchim, 19370, Germany

  • Novartis Investigative Site

    RECRUITING

    Potsdam, 14467, Germany

  • Novartis Investigative Site

    RECRUITING

    Potsdam, 14482, Germany

  • Novartis Investigative Site

    RECRUITING

    Schorndorf, 73614, Germany

  • Novartis Investigative Site

    RECRUITING

    Schwetzingen, 68723, Germany

  • Novartis Investigative Site

    RECRUITING

    Soest, 59494, Germany

  • Novartis Investigative Site

    RECRUITING

    Stade, 21680, Germany

  • Novartis Investigative Site

    RECRUITING

    Torgau, 04860, Germany

  • Novartis Investigative Site

    RECRUITING

    Wetzlar, 35578, Germany

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