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Efficacy of asciminib in chronic phase chronic myeloid leukemia patients with T315I mutation

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What is this trial about?

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

The trial is looking at patients with Chronic Myeloid Leukemia that have a specific change called T315I in the cancer cells. The medicine being tested is asciminib, taken as a tablet by mouth.

The purpose of the study is to see whether the medicine can lower the amount of abnormal genetic material (BCR::ABL1) in the blood after one year. Participants will take the tablet each day for up to two years and will have regular visits where blood is drawn to check the genetic material using a test called PCR and a more detailed test called NGS.

During the study, quality of life will be asked about at several time points, and doctors will also watch for any signs that the disease gets worse or that the patient experiences serious side effects.

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

    Enrollment visit

    You attend the first clinic appointment after joining the study. during this visit you sign the consent form and confirm that you meet the eligibility criteria for chronic myeloid leukemia with a t315i mutation.

    Baseline assessments are performed, including a blood draw for bcr::abl1 measurement by pcr, next‑generation sequencing (ngs) to evaluate the t315i clone, and a quality of life questionnaire.

  2. Step 2

    Start of medication

    You begin taking asciminib as a film‑coated tablet taken by mouth.

    The prescribed dose is 400 mg once daily, taken with or without food, and you continue this dose for the duration of the study, which may be up to 24 months.

  3. Step 3

    Regular follow‑up visits

    You return to the clinic for scheduled visits at month 3, month 6, month 9, month 12, month 18, and month 24 after starting asciminib.

    At each visit a blood sample is collected for bcr::abl1 measurement by pcr to monitor molecular response.

    Quality of life questionnaires are completed at each of these time points.

  4. Step 4

    Primary endpoint assessment

    At month 12 a specific pcr test is performed to determine whether the molecular response level mr2 has been achieved, which is the primary goal of the trial.

  5. Step 5

    Secondary endpoint assessments

    The size of the t315i positive bcr::abl1 clone is measured by ngs at month 12 to evaluate reduction of the mutant clone.

    Additional molecular response assessments are performed by pcr at month 6, month 18, and month 24.

    Progression‑free survival, cml‑related death, and overall survival are monitored throughout the study until its end.

  6. Step 6

    Final study visit

    At month 24 you attend the last study visit.

    Final blood tests, pcr and ngs assessments, and a quality of life questionnaire are completed.

    The study data are compiled to evaluate the overall effectiveness and safety of asciminib in your condition.

Who can join the trial?

9 criteria

  • Must have chronic myeloid leukemia that shows the **BCR::ABL1** gene abnormality, be in the early stable stage (first or second chronic phase), and have a confirmed **T315I mutation** found by a DNA test called **Sanger sequencing** or **next‑generation sequencing (NGS)**.
  • Must be at least 18 years old; there is no upper age limit.
  • Must have an **ECOG performance status** of 2 or lower, meaning you can take care of yourself and are not confined to bed.
  • Blood levels of **potassium**, **magnesium**, and **total calcium** must be within the normal range; if needed, supplements can be used to correct them before joining.
  • Liver enzymes **AST** and **ALT** must be no more than 2.5 times the normal upper limit (or up to 5 times if the increase is caused by leukemia).
  • The liver enzyme **alkaline phosphatase** must be no more than 2.5 times the normal upper limit unless the rise is due to leukemia.
  • Blood pigment **total bilirubin** must be no more than 1.5 times the normal upper limit, except if you have a known harmless condition called **Gilbert disease**.
  • Kidney function measured by **serum creatinine** must be no more than twice the normal upper limit.
  • You must sign a **written informed consent** before any study procedures are performed.

Who cannot join the trial?

19 criteria

  • Having taken the drug asciminib before the study starts.
  • Having had major surgery within the last 2 weeks or not fully recovered from surgery side effects.
  • Being pregnant, breastfeeding, or being able to become pregnant and not using an effective method of birth control; also, women who could become pregnant must have a negative pregnancy test within 14 days before the study starts, and post‑menopausal women must have had no periods for at least 12 months.
  • Not agreeing to use reliable birth control during the study and for 2 weeks after stopping the study drug; men must use a condom even if they have had a vasectomy, and female partners must also use effective contraception.
  • Having a known diagnosis of HIV (human immunodeficiency virus) infection.
  • Having an active autoimmune disorder, such as the body mistakenly attacking its own tissues, including autoimmune hepatitis (liver inflammation caused by the immune system).
  • Having a history of another primary cancer that is currently important or needs treatment.
  • Being unwilling or unable to follow the study instructions.
  • Having a specific genetic form of the disease that lacks the ABL1 exon a2 segment, which may make the study drug ineffective.
  • Having known heart problems, such as:
    • Congenital long QT syndrome (a condition that can cause dangerous heart rhythm changes).
    • A history of serious fast heart rhythms (ventricular or atrial tachyarrhythmia).
    • A QTc interval longer than 450 milliseconds on an electrocardiogram (ECG).
    • A heart attack (myocardial infarction) within the past 12 months.
    • Having other serious heart disease, such as unstable chest pain (angina) or congestive heart failure.
    • Having acute or chronic viral hepatitis with moderate or severe liver damage (Child‑Pugh score greater than 6), even if the hepatitis is otherwise controlled.
    • Having other uncontrolled medical conditions, such as active infections, severe liver disease, or kidney disease, that could create safety risks or make it hard to follow the study.
    • Having gastrointestinal problems that could affect how the study drug is absorbed, such as ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, removal of part of the small intestine, or gastric bypass surgery.
    • Having chronic pancreatitis (long‑term inflammation of the pancreas).
    • Taking other medicines that strongly increase or decrease the activity of the enzyme CYP3A4, which is important for processing many drugs.
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Investigated drugs

Asciminib is an oral medication taken as a film‑coated tablet. It is designed for patients with chronic phase chronic myeloid leukemia (CML) who have a specific T315I mutation. In this trial, the drug is being tested to see if it can lower the amount of cancer‑related genetic material (BCR::ABL1) in the blood after 12 months of treatment. Asciminib is considered an orphan drug, which means it is intended for a rare condition and may have special regulatory support.

What is already known about the treatment

Asciminib - This medication is taken by mouth as a film‑coated tablet, typically 400 mg once daily. It is an approved drug for treating chronic myeloid leukemia, especially in patients with the T315I mutation, and is listed in current medical guidelines and literature. Asciminib works by binding to a specific part of the BCR‑ABL protein, stopping it from sending signals that make cancer cells grow. It belongs to the class of targeted therapies known as allosteric BCR‑ABL inhibitors.

Investigated diseases

Chronic Myeloid Leukemia - Chronic Myeloid Leukemia is a blood disease that begins in the bone marrow and leads to an excess of white blood cells. It typically starts with a slow increase in these cells, often causing few symptoms at first. Over time the disease may move into a faster‑growing phase where the abnormal cells multiply more rapidly. The condition is driven by a specific genetic change called BCR::ABL1, which promotes the uncontrolled cell growth. As the disease progresses, the share of abnormal cells in the blood can rise, altering blood counts and causing additional signs.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523491-23-00Protocol codeESTIMATIONEstimated enrolment50 patientsSponsorFriedrich-Schiller-Universitaet Jena

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