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Study Comparing Asciminib with Other Drug Combinations for Adults with Newly Diagnosed Chronic Myeloid Leukemia

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 is focused on studying a type of blood cancer called Chronic Myeloid Leukemia (CML), specifically in its early stage known as the chronic phase. The study is comparing the effectiveness of a new treatment called Asciminib Hydrochloride with other existing treatments chosen by doctors, which include Imatinib, Dasatinib, Nilotinib, and Bosutinib. These treatments are known as tyrosine kinase inhibitors (TKIs), which are medications that help block the growth of cancer cells.

The purpose of the study is to see how well Asciminib Hydrochloride works compared to the other TKIs in helping patients achieve a significant reduction in cancer cells, known as a Major Molecular Response, by the 48th week of treatment. Participants in the study will be randomly assigned to receive either Asciminib Hydrochloride or one of the other TKIs. The study will last for a period of up to 72 weeks, during which participants will take the medication orally, meaning by mouth, in the form of tablets or capsules.

Throughout the study, participants will have regular check-ups to monitor their health and the effectiveness of the treatment. The study aims to provide valuable information on the best treatment options for patients newly diagnosed with Chronic Myeloid Leukemia in the chronic phase. This research could help improve treatment strategies and outcomes for patients with this type of leukemia.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be randomly assigned to receive either asciminib or another medication chosen by the investigator. These medications are known as tyrosine kinase inhibitors (TKIs) and are used to treat chronic myeloid leukemia (CML).

  2. Step 2

    Medication administration

    The participant will take the assigned medication orally. The specific dosage and frequency will be determined by the study protocol and the investigator's decision. The medications involved in the study include imatinib, bosutinib, dasatinib, nilotinib, and asciminib hydrochloride.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the participant will undergo regular monitoring to assess the effectiveness of the treatment. This includes checking for a major molecular response (MMR) at specific intervals, such as Week 48 and Week 96. MMR is a measure of how well the leukemia is responding to treatment.

  4. Step 4

    End of study

    The study is expected to conclude by January 18, 2028. At the end of the study, the participant's response to the treatment will be evaluated to determine the overall effectiveness of the medication.

Who can join the trial?

15 criteria

  • Participants must be male or female and at least 18 years old.
  • Participants should have been diagnosed with Chronic Myeloid Leukemia in Chronic Phase (CML-CP) within the last 3 months.
  • The diagnosis of CML-CP must be confirmed by a test showing the presence of the Philadelphia chromosome, a specific genetic change.
  • Participants must have less than 15% blasts (immature blood cells) in their blood and bone marrow.
  • Participants must have less than 30% of blasts plus promyelocytes (a type of immature blood cell) in their blood and bone marrow.
  • Participants must have less than 20% basophils (a type of white blood cell) in their blood.
  • Participants must have a platelet count of at least 100,000 per cubic millimeter of blood.
  • There should be no evidence of leukemia outside the bone marrow, except for possible enlargement of the liver or spleen.
  • Participants must have an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work.
  • Participants must have adequate function of their organs, including:
    • Total bilirubin (a substance made by the liver) less than 3 times the normal upper limit, unless they have a condition called Gilbert's syndrome.
    • Creatinine clearance (a measure of kidney function) of at least 30 mL/min.
    • Serum lipase (an enzyme related to the pancreas) less than 1.5 times the normal upper limit.
    • Participants must have certain laboratory values within normal limits or corrected to normal with supplements, including:
      • Potassium, calcium, and magnesium levels.
      • Participants must sign an informed consent form before any study-related procedures are done.
      • Participants must have evidence of a specific genetic marker called BCR-ABL1 transcript that can be measured using a standardized test.

Who cannot join the trial?

4 criteria

  • Patients who are not diagnosed with Chronic Myeloid Leukemia cannot participate. Chronic Myeloid Leukemia is a type of cancer that affects the blood and bone marrow.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Both male and female patients are eligible, but those who do not identify as either cannot participate.
  • Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.
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Investigated drugs

  • Asciminib

    is a medication being studied for its effectiveness in treating patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in the chronic phase. It is taken orally and works by specifically targeting and inhibiting a protein that is involved in the growth of cancer cells. The goal is to see if asciminib can help more patients achieve a significant reduction in cancer cell levels by Week 48 of treatment.

  • Investigator Selected TKI

    refers to a group of medications known as tyrosine kinase inhibitors (TKIs) that are chosen by the study investigators for comparison against asciminib. These medications are commonly used to treat chronic myelogenous leukemia by blocking the action of proteins that promote the growth of cancer cells. The study aims to compare the effectiveness of asciminib with these TKIs in achieving a major molecular response in patients.

What is already known about the treatment

Asciminib – Asciminib is administered orally and is currently being studied in clinical trials for its effectiveness in treating Chronic Myeloid Leukemia (CML). It is in the phase III stage of clinical trials, where its efficacy is being compared to other treatments selected by investigators. The main therapeutic indication for asciminib is for patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in the chronic phase. At the molecular level, asciminib works by specifically inhibiting the BCR-ABL1 protein, which is responsible for the uncontrolled growth of cancer cells in CML. It is classified pharmacologically as a tyrosine kinase inhibitor (TKI).

Investigated diseases

Chronic Myeloid Leukemia – Chronic Myeloid Leukemia (CML) is a type of cancer that affects the blood and bone marrow. It is characterized by the overproduction of immature white blood cells, known as myeloid cells. These cells gradually accumulate in the blood and bone marrow, interfering with the production of normal blood cells. CML typically progresses through three phases: chronic, accelerated, and blast crisis, with each phase showing an increase in the number of abnormal cells. In the chronic phase, symptoms may be mild or absent, but as the disease progresses, symptoms such as fatigue, weight loss, and an enlarged spleen may occur. The disease is often associated with a specific genetic abnormality known as the Philadelphia chromosome.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508838-33-00Protocol codeCABL001J12301Estimated enrolment405 patientsSponsorNovartis Pharma AG

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