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Study of Asciminib Treatment for Newly Diagnosed Patients with Chronic Myeloid Leukemia in Chronic Phase

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with Chronic Myeloid Leukemia (CML) who have been newly diagnosed with the disease. The study evaluates a treatment using asciminib hydrochloride, a medication that works by targeting specific proteins involved in cancer cell growth. The medication is taken by mouth in the form of tablets, with a maximum daily dose of 80 mg.

The purpose of this research is to evaluate how well the combination of asciminib with other medications that target the same cancer-causing proteins works in achieving a deep reduction in cancer cells in patients who have not received previous treatment for their disease. The treatment period lasts for 21 days, and patients will be monitored to assess how their body responds to the medication.

The study involves regular medical check-ups to monitor the patient's health status and response to treatment. Blood tests will be performed to measure the levels of cancer cells and to check how well the patient's organs are functioning. The medication being studied is designed to specifically target the genetic change that causes this type of leukemia, known as the Philadelphia chromosome.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial diagnosis confirmation

    Confirmation of Chronic Myeloid Leukemia (CML) diagnosis through cytogenetic testing

    Verification of the presence of Philadelphia chromosome or BCR-ABL1 positive status

  2. Step 2

    Medical evaluation

    Assessment of general health condition and performance status

    Laboratory tests including:

    - Blood tests for liver function (AST, ALT)

    - Kidney function test (serum creatinine)

    - Electrolyte levels (potassium, magnesium, calcium)

    - Lipase levels

    - Total bilirubin

  3. Step 3

    Treatment initiation

    Beginning of treatment with asciminib

    Medication will be taken by mouth (oral administration)

    Treatment continues as part of the study until 2027

  4. Step 4

    Response monitoring

    Regular monitoring of molecular response to treatment

    Key evaluation of treatment response at 12 months

    Assessment of deep molecular response (MR4)

  5. Step 5

    Ongoing assessments

    Regular laboratory tests to monitor organ function

    Continuous evaluation of treatment effectiveness

    Monitoring for any side effects

Who can join the trial?

11 criteria

  • Must be at least 18 years old (no upper age limit)
  • Can be either male or female
  • Must have confirmed diagnosis of Chronic Myeloid Leukemia in chronic phase with specific genetic markers (Philadelphia chromosome positive or BCR-ABL1 positive)
  • Must have ECOG performance status of 2 or better (able to carry out most daily activities)
  • Must provide written informed consent before starting any study procedures
  • Blood tests must show:
    • Liver enzymes (AST and ALT) no more than 2.5 times above normal limit
    • Lipase levels no more than 1.5 times above normal limit
    • Normal levels of potassium, magnesium, and calcium
    • Total bilirubin no more than 1.5 times above normal (except for patients with Gilbert's disease)
    • Creatinine levels no more than 2 times above normal limit
    • Alkaline phosphatase must be no more than 2.5 times above normal limit (unless related to leukemia)

Who cannot join the trial?

15 criteria

  • Prior treatment with any medication for Chronic Myeloid Leukemia (CML)
  • Known severe allergic reactions to similar medications
  • Presence of BCR-ABL1 mutations (genetic changes in blood cells)
  • Active or uncontrolled infections
  • Major surgery within 4 weeks before starting the study
  • Significant heart problems or irregular heart rhythm
  • Severe liver problems (impaired liver function)
  • Severe kidney problems (impaired kidney function)
  • Pregnant or breastfeeding women
  • Unable to swallow oral medications
  • Current participation in another clinical trial
  • Mental conditions that could interfere with study compliance
  • Any condition that the study doctor believes would make participation unsafe
  • History of other cancers within the past 3 years (except treated skin cancer)
  • Uncontrolled high blood pressure
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Investigated drugs

Asciminib is a medication used to treat chronic myeloid leukemia (CML). It works by targeting and blocking specific proteins called BCR-ABL1 that cause the cancer cells to grow. This medication belongs to a class of drugs known as ATP-competitive inhibitors, which means it competes with ATP (a natural molecule in cells) to block cancer cell growth. It is used as a treatment for patients who have been newly diagnosed with CML.

What is already known about the treatment

Asciminib - An oral medication specifically designed for treating Chronic Myeloid Leukemia (CML), representing a new class of drugs known as ABL kinase inhibitors. This innovative treatment works by targeting the BCR-ABL1 protein at its myristoyl pocket, which is different from traditional CML treatments, making it effective even in cases where other therapies have failed. Asciminib is administered in tablet form and belongs to the pharmacological class of targeted cancer therapies, acting at the molecular level to block the abnormal protein that drives leukemia cell growth. The medication has shown promising results in clinical trials for newly diagnosed CML patients, particularly in achieving deep molecular responses.

Investigated diseases

Chronic Myeloid Leukemia - A type of blood cancer that begins in the bone marrow when abnormal white blood cells start growing uncontrollably. The condition develops gradually, typically progressing through three phases: chronic, accelerated, and blast phase. In this disease, a genetic change creates an abnormal protein that causes the bone marrow to produce too many white blood cells. These abnormal cells build up in the bone marrow and spill into the bloodstream, but initially may cause few or no symptoms. Over time, the abnormal cells can crowd out healthy blood cells and affect bone marrow function.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516212-24-00Protocol codeFASCINATIONEstimated enrolment125 patientsSponsorFriedrich-Schiller-Universitaet Jena

sourced from the EU Clinical Trials Register and site verification

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