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Study for Adults with Chronic Myeloid Leukemia Using Asciminib Alone or with Nilotinib

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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 a form that is positive for a genetic marker known as BCR-ABL1. The study is exploring the effectiveness of a medication called Asciminib, which can be used alone or in combination with another medication called Tasigna (nilotinib). Both medications are taken orally, with Asciminib available as film-coated tablets and Tasigna as hard capsules.

The purpose of the study is to evaluate how well these treatments work in achieving a deep molecular response, which means a significant reduction in cancer cells, in patients who are newly diagnosed with this type of leukemia. Participants will receive treatment over a period of time, and their response to the medication will be monitored regularly. The study aims to understand how quickly and effectively the treatments can reduce the presence of cancer cells in the blood.

Throughout the study, researchers will also observe the long-term outcomes for patients, including their overall survival and the possibility of maintaining remission without ongoing treatment. The study will help determine the best approach for using Asciminib and Tasigna in treating patients with Chronic Myeloid Leukemia who have the BCR-ABL1 marker. This research is important for improving treatment strategies and outcomes for individuals with this specific type of leukemia.

The research process

The trial runs in 6 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, you will be required to provide a signed written informed consent. This is a document that confirms your understanding of the study and your agreement to participate.

    You will need to confirm your diagnosis of BCR-ABL1+ Chronic Myeloid Leukemia and meet specific health criteria, such as adequate organ function and a performance status that allows participation.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate your health status and confirm eligibility. This may include blood tests and other diagnostic procedures to ensure you meet the study's inclusion criteria.

  3. Step 3

    Treatment phase

    You will begin treatment with either asciminib hydrochloride or a combination of asciminib hydrochloride and nilotinib. These medications are taken orally.

    Scemblix is provided as 40 mg film-coated tablets, and Tasigna is provided as 150 mg hard capsules. The specific dosage and frequency will be determined by the study protocol and your healthcare provider.

  4. Step 4

    Ongoing monitoring

    Throughout the study, regular monitoring will be conducted to assess your response to the treatment. This includes blood tests to measure the levels of the BCR-ABL1 transcript, which helps determine the effectiveness of the treatment.

    You may be required to visit the study site periodically for these assessments.

  5. Step 5

    Evaluation of response

    The primary goal is to achieve a deep molecular response (MR4) within two years. This means a significant reduction in the BCR-ABL1 transcript levels.

    If the molecular analysis is not evaluable, a repeat test may be conducted one month later.

  6. Step 6

    Long-term follow-up

    The study will continue to monitor your health and response to treatment over several years. This includes evaluating sustained responses and overall survival rates.

    You will be assessed for eligibility to discontinue treatment if certain response criteria are met.

Who can join the trial?

15 criteria

  • Confirmed diagnosis of **Ph+ and BCR::ABL1+ CML**. This means the patient has a specific type of chronic myeloid leukemia.
  • Must be **18 years or older**.
  • In the **early chronic phase** of the disease, which means less than 3 months from diagnosis.
  • Evidence of specific **BCR::ABL1 RNA transcripts** (e13a2 or e14a2) at the time of study entry. These are specific genetic markers needed for reporting.
  • Previous treatment with any **TKI** (a type of cancer drug) for **30 days or less** is allowed. Prior treatment with **hydroxyurea** or **anagrelide** is also allowed.
  • **ECOG performance status** of 0, 1, or 2. This is a scale that measures how well a patient can perform daily activities.
  • **Adequate end organ function**, which includes:
    • Total **bilirubin** ≤ 1.5 times the upper limit of normal (ULN), except for patients with **Gilbert’s syndrome** who may have total bilirubin ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN.
    • **Aspartate transaminase (AST)** ≤ 3.0 x ULN.
    • **Alanine transaminase (ALT)** ≤ 3.0 x ULN.
    • **Serum amylase** ≤ 1.5 x ULN.
    • **Serum lipase** ≤ 1.5 x ULN.
    • **Alkaline phosphatase** ≤ 2.5 x ULN, unless related to the tumor.
    • **Creatinine clearance** > 50 ml/min using the **Cockcroft-Gault formula**. This measures kidney function.
    • Signed written **informed consent** according to international and local laws before any study procedure. This means the patient agrees to participate after understanding the study.
    • Use of an effective form of **contraception** with sexual partners from enrollment through 30 days after the end of treatment.

Who cannot join the trial?

4 criteria

  • Patients who do not have BCR-ABL1+ Chronic Myeloid Leukemia cannot participate. This is a specific type of blood cancer.
  • Patients who are not in the early phase of Chronic Myeloid Leukemia cannot participate. The early phase is the initial stage of the disease.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection or care.
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Investigated drugs

  • Asciminib

    is a medication used in this clinical trial to treat a type of blood cancer called Chronic Myeloid Leukemia (CML). It works by specifically targeting and blocking a protein that helps cancer cells grow. By doing this, asciminib can help stop the cancer from progressing and may lead to a reduction in cancer cells in the body.

  • Nilotinib

    is another medication used in this trial, either alone or in combination with asciminib. It is also used to treat Chronic Myeloid Leukemia (CML). Nilotinib works by inhibiting the activity of a specific protein that is involved in the growth of cancer cells. This helps to slow down or stop the progression of the disease, potentially leading to a decrease in the number of cancer cells.

What is already known about the treatment

  • Asciminib

    Asciminib is administered orally in the form of a tablet. It is currently being studied in clinical trials for its effectiveness in treating BCR-ABL1+ Chronic Myeloid Leukemia (CML). The main therapeutic use of asciminib is to help manage this type of leukemia by targeting a specific protein that contributes to cancer cell growth. At the molecular level, asciminib works by inhibiting the activity of the BCR-ABL1 protein, which is responsible for the uncontrolled growth of cancer cells in CML. It is classified as a tyrosine kinase inhibitor, a type of medication that blocks certain enzymes involved in cancer cell proliferation.

  • Nilotinib

    Nilotinib is also taken orally in tablet form. It is an established medication used in the treatment of BCR-ABL1+ Chronic Myeloid Leukemia and is being studied in combination with asciminib for enhanced effectiveness. Nilotinib's primary therapeutic role is to treat CML by inhibiting the BCR-ABL1 protein, similar to asciminib, thereby preventing the growth and spread of cancer cells. It belongs to the pharmacological class of tyrosine kinase inhibitors, which are designed to block the action of enzymes that promote cancer cell growth.

Investigated diseases

Chronic Myeloid Leukemia – Chronic Myeloid Leukemia (CML) is a type of cancer that starts in certain blood-forming cells of the bone marrow. It leads to the overproduction of abnormal white blood cells. The disease progresses slowly and can remain in a chronic phase for several years. Over time, CML can advance to an accelerated phase, where the disease becomes more aggressive. Eventually, it may progress to a blast crisis phase, resembling acute leukemia, with rapid growth of immature white blood cells. The progression of CML is driven by a genetic change known as the BCR-ABL1 fusion gene, which increases the activity of an enzyme called tyrosine kinase, leading to uncontrolled cell growth.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512696-12-00Protocol codeCML1624Estimated enrolment160 patientsSponsorFondazione Gimema Franco Mandelli Onlus

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