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Study on Asciminib and Asciminib Hydrochloride for Patients with Chronic Myelogenous Leukemia in Chronic Phase After Two or More Tyrosine Kinase Inhibitors

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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 Myelogenous Leukemia in chronic phase (CML-CP). The study is testing a treatment using a medication called Asciminib, which is taken as a film-coated tablet. Another form of the medication, known as Asciminib Hydrochloride, is also being used. Both forms of the medication are taken orally, meaning they are swallowed like a pill.

The purpose of the study is to see how well patients with CML-CP respond to Asciminib after they have already been treated with at least two other medications called tyrosine kinase inhibitors (TKIs). These TKIs include drugs like imatinib, nilotinib, dasatinib, bosutinib, radotinib, or ponatinib. The study will look at how many patients achieve a specific type of response called a molecular response at different times, such as at 48 weeks. The study will also monitor the safety of the treatment by checking for any side effects and changes in health markers.

Participants in the study will take the medication for a period of up to 144 weeks. During this time, they will have regular check-ups to monitor their health and the effectiveness of the treatment. The study aims to provide more information on how well Asciminib works for patients with CML-CP who have not had success with other treatments.

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

    Joining the study

    Participation begins after signing an informed consent form. This confirms understanding of the study and agreement to participate.

    Eligibility includes being 18 years or older with a diagnosis of Chronic Myelogenous Leukemia in chronic phase (CML-CP) and previous treatment with at least two tyrosine kinase inhibitors (TKIs).

  2. Step 2

    Treatment initiation

    The treatment involves taking asciminib orally. The specific dosage and frequency will be provided by the healthcare team.

    The goal is to optimize treatment for those who have not achieved a molecular response with previous TKI therapies.

  3. Step 3

    Monitoring and assessments

    Regular monitoring will occur to assess the response to treatment. This includes checking for molecular response rates at various intervals: weeks 12, 24, 36, 48, 72, 96, and 144.

    Safety assessments will be conducted to monitor for any adverse effects, changes in laboratory values, and other health indicators.

  4. Step 4

    End of treatment evaluation

    The primary endpoint is to achieve a molecular response at 48 weeks.

    Secondary endpoints include evaluating the type and frequency of adverse events, and other health outcomes over the course of the study.

  5. Step 5

    Completion of study

    The study is estimated to conclude by January 20, 2025.

    Final assessments will be conducted to evaluate the overall effectiveness and safety of the treatment.

Who can join the trial?

6 criteria

  • The patient must provide a signed informed consent before joining the study. This means they agree to participate after understanding the details of the study.
  • The patient must be a male or female who is at least 18 years old and has been diagnosed with **Chronic Myelogenous Leukemia in chronic phase (CML-CP)**.
  • The patient must have been treated with at least two or more previous **TKIs**. TKIs are a type of medication used to treat certain types of cancer, including imatinib, nilotinib, dasatinib, bosutinib, radotinib, or ponatinib.
  • The patient must have experienced a warning or failure of the most recent TKI therapy, or they must not be able to tolerate it. This is based on guidelines from the **2020 ELN Recommendations**.
  • The patient must have an **ECOG performance status** of 0, 1, or 2. This is a scale used to assess how a patient's disease is affecting their daily living abilities, with 0 being fully active and 2 indicating some limitations but still able to care for themselves.
  • The patient must have adequate end organ function, which will be determined by specific laboratory tests.

Who cannot join the trial?

6 criteria

  • Patients who have not been diagnosed with Chronic Myelogenous Leukemia in chronic phase (CML-CP). This is a type of blood cancer that affects the bone marrow and blood.
  • Patients who have not received at least two previous treatments with TKI medications. TKI stands for Tyrosine Kinase Inhibitors, which are drugs used to treat certain types of cancer.
  • Patients who already show a molecular response at the start of the study. A molecular response means that the cancer cells in the blood are reduced to a very low level.
  • Patients who are not within the specified age range for the study.
  • Patients who are not willing or able to follow the study procedures.
  • Patients who are part of a vulnerable population that the study is not designed to include.
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Investigated drugs

Asciminib is a medication being studied for its effectiveness in treating patients with Chronic Myelogenous Leukemia in the chronic phase. It is used in patients who have already been treated with two or more tyrosine kinase inhibitors but have not achieved a molecular response. Asciminib works by targeting specific proteins in cancer cells, which may help to stop their growth and spread.

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 Myelogenous Leukemia in the chronic phase (CML-CP), particularly in patients who have previously been treated with two or more tyrosine kinase inhibitors. It is classified as a tyrosine kinase inhibitor and works by specifically targeting the BCR-ABL1 protein, which is responsible for the uncontrolled growth of cancer cells in CML. By inhibiting this protein, asciminib helps to slow down or stop the progression of the disease. The medication is still under investigation, and its full potential and safety profile are being evaluated in ongoing studies.

Investigated diseases

Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) – This is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of white blood cells. In the chronic phase, the disease progresses slowly and may not cause noticeable symptoms initially. Over time, the accumulation of abnormal cells can lead to fatigue, weight loss, and an increased risk of infections. The chronic phase is typically the earliest stage of the disease, where the body still functions relatively normally. If untreated, CML-CP can progress to more aggressive phases. The disease is often associated with a specific genetic abnormality known as the Philadelphia chromosome.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511381-36-00Protocol codeCABL001A2302Estimated enrolment203 patientsSponsorNovartis Pharma AG

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