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Can a new drug combo push CML into deep remission?

NCT ID NCT03906292

Disease control Sponsor: University of Jena 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether adding the experimental drug asciminib to standard treatments (imatinib, nilotinib, or dasatinib) can achieve deeper molecular responses in adults newly diagnosed with chronic-phase chronic myeloid leukemia (CML). Participants receive one of several combination regimens or asciminib alone, and the study measures how well the leukemia is suppressed at a molecular level. The goal is to see if these combinations can improve treatment outcomes and quality of life for people with this blood cancer.

What this could mean

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

Active substance
asciminib combined with imatinib, nilotinib, or dasatinib
What this could lead to
If successful, this could lead to more effective first-line treatment options for chronic myeloid leukemia, potentially achieving deeper remission and better long-term outcomes.
What could go wrong
This is a phase 2 trial, so results are preliminary. The combinations may not improve response rates over standard therapy, and there are risks of side effects from the drugs.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

125 people

The number who actually took part.

Started

Aug 2019

Expected to finish

Dec 2027

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.

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: * Male or female patients with diagnosis of CP-CML with cytogenetic confirmation of the Ph+ chromosome \[t(9;22)(q34;q11)\]. * Ph-negative cases or patients with variant translocations who are BCR-ABL1 positive in multiplex PCR 35 will be also considered eligible. * ECOG performance status of ≤2. * Age ≥ 18 years old (no upper age limit is given) * Serum levels of potassium, magnesium, total calcium within the normal limits (≥LLN \[lower limit of normal\] and ≤ULN \[upper limit of normal\]). Correction of electrolytes levels with supplements to fulfil enrolment criteria is allowed. * AST and ALT ≤2.5 x ULN or 5.0 x ULN if considered due to leukemia * Alkaline phosphatase ≤2.5 x ULN unless considered due to leukemia * Total bilirubin ≤1.5 x ULN, except known Gilbert disease * Serum creatinine ≤2 x ULN * Written informed consent prior to any study procedures being performed. Exclusion Criteria: * Allogeneic stem cell transplantation * Known impaired cardiac function, including any of the following: * Congenital long QT syndrome * History of or presence of clinically significant ventricular or atrial tachyarrhythmia * QTc \>450 msec on screening ECG * Myocardial infarction within 12 months prior to starting therapy * Other clinical significant heart disease (e.g. unstable angina, congestive heart failure) * Acute or chronic viral hepatitis with moderate or severe hepatic impairment (Child-Pugh scores \>6), even if controlled * Other concurrent uncontrolled medical conditions (e.g., active or uncontrolled infections, acute or chronic liver and renal disease) that could cause unacceptable safety risks or compromise compliance with the protocol * Impaired gastrointestinal function or disease that may alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting and diarrhea, malabsorption syndrome, small bowel resection or gastric by-pass surgery) * Concomitant medications known to be strong inducers or inhibitors of the CYP450 isoenzyme CYP3A4 * Patients who have undergone major surgery ≤2 weeks prior to starting study drug or who have not recovered from side effects of such therapy * Patients who are pregnant or breastfeeding or women of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study start. Post-menopausal women must be amenorrheic for at least 12 months in order to be considered of non-childbearing potential. Male and female patients must agree to employ an effective method of birth control throughout the study and for up to 2 weeks following discontinuation of study drug * Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory) * Known serious hypersensitivity reactions to asciminib, imatinib, nilotinib or dasatinib * Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention * Patients unwilling or unable to comply with the protocol.

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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.

Chronic myeloid leukemia

Contacts and locations

Locations

  • Brüderkrankenhaus St. Josef Paderborn

    Paderborn, 33098, Germany

  • Charite Universitätsmeditin Berlin, Campus Virchow Klinikum

    Berlin, 13353, Germany

  • GOKOS GmbH

    Dresden, 01307, Germany

  • Gemeinschaftspraxis Dres. Müller/ Kröning/ Jentsch-Ullrich/ Tietze/ Krogel

    Magdeburg, 39104, Germany

  • Klinikum Bremen Mitte

    Bremen, 28177, Germany

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09113, Germany

  • Klinikum rechts der Isar

    München, 81675, Germany

  • Krankenhaus Barmherzige Brüder Regensburg

    Regensburg, 93049, Germany

  • Universitätsklinikum Aachen Medizinische Klinik IV

    Aachen, 52074, Germany

  • Universitätsklinikum Bonn

    Bonn, 53105, Germany

  • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

    Dresden, 01307, Germany

  • Universitätsklinikum Erlangen

    Erlangen, 91054, Germany

  • Universitätsklinikum Essen

    Essen, 45122, Germany

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590, Germany

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106, Germany

  • Universitätsklinikum Gießen und Marburg

    Marburg, 35043, Germany

  • Universitätsklinikum Jena

    Jena, 07747, Germany

  • Universitätsklinikum Leipzig

    Leipzig, 04103, Germany

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

  • Universitätsmedizin Mannheim

    Mannheim, 68169, Germany

  • Universitätsmedizin der Johannes- Gutenberg Universität Mainz

    Mainz, 55131, Germany

More trials for these conditions

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