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Long-Term Safety Study of Asciminib in Patients With Chronic Myelogenous Leukemia or Philadelphia Chromosome-Positive Acute Lymphoblastic 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 study is for people with chronic myelogenous leukemia (also called CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). It is an open-label study, which means the treatment is known to the study team and the participants. The treatment used in the study is asciminib hydrochloride, taken by mouth. The purpose of the study is to check the long-term safety of continuing asciminib after a previous study.

The study follows people who have already completed an earlier asciminib study and are considered by the doctor to still benefit from treatment. Treatment is continued over time, and regular study visits are planned so that health and any side effects can be watched. The study looks at possible adverse events, which are unwanted health problems that happen during treatment, and serious adverse events, which are more severe health problems. In some parts of the study, other tyrosine kinase inhibitors that may have been used in earlier studies include nilotinib, dasatinib, imatinib, and bosutinib.

The study is designed to provide continued access to the same study treatment received before while long-term safety is followed over time.

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

    Study entry

    You enter this open label study after completing a previous Novartis asciminib study and after the investigator judges that you may benefit from continued treatment.

    This study is for people with chronic myelogenous leukemia (CML, a cancer of the blood and bone marrow) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL, a fast-growing blood cancer with a specific chromosome change).

  2. Step 2

    Study treatment

    You take asciminib hydrochloride by mouth at a dose of 560 mg.

    The medicine is taken as oral use, which means it is swallowed.

    The study is designed to provide continued access to the study treatment you received in the parent study.

    The treatment continues for the study period, which is planned within the overall study timeline from 30 august 2022 to 30 august 2030.

  3. Step 3

    Scheduled visits

    You attend scheduled visits during the study.

    At these visits, the investigator assesses whether you have clinical benefit, which means whether the treatment is still helping you.

    The study collects information on adverse events (medical problems during the study) and serious adverse events (more serious medical problems) to assess long-term safety.

    The main focus of these visits is the frequency and severity of these medical problems.

  4. Step 4

    Ongoing study follow-up

    You remain in the study while treatment continues and while your safety and response are checked at the scheduled visits.

    The study continues to record the long-term safety of asciminib and whether you continue to have benefit from the treatment.

Who can join the trial?

5 criteria

  • You must have Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The Philadelphia chromosome is a change in the leukemia cells’ chromosomes, which are the structures that carry genes.
  • You must be currently receiving asciminib, either by itself or together with imatinib, nilotinib, or dasatinib. These are medicines used to treat leukemia.
  • Or, if you were in the comparator arm of a Novartis-sponsored study, you must be receiving the study treatment that was assigned in that group. A comparator arm is the group used for comparison in a clinical trial.
  • You must have already met the requirements for the main part of the study and have finished the treatment phase.
  • The study doctor must think that you would benefit from continuing treatment.

Who cannot join the trial?

7 criteria

  • The person was stopped from treatment in the parent study for any reason.
  • The person still has severe side effects from the parent study that are thought to be possibly related to the study treatment. Grade 3 or 4 means a serious or very serious side effect. These side effects must not have improved to Grade 2 or lower within the allowed time: 42 days for blood-related side effects, or 28 days for side effects not related to blood.
  • The person needs to stop study treatment for longer than the allowed time because of ongoing side effects: more than 42 days for hematological toxicities (blood-related side effects) or more than 28 days for non-hematological toxicities (side effects not related to blood).
  • The person’s current treatment is already approved and paid for at the country level. This means the treatment is already available through normal care in that country.
  • The person is pregnant.
  • The person is breastfeeding or nursing.
  • The person is a woman who can become pregnant and is not using a highly effective method of birth control.
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Investigated drugs

  • Asciminib

    is the main study medicine in this trial. It is taken by mouth and is being continued in people who already used it in a previous study and were thought to still benefit from it. The trial is mainly looking at how safe long-term use of this medicine is, including any serious side effects or other unwanted effects over time.

  • Nilotinib

    is another oral cancer medicine included in the study group. It is used as an active treatment option for people with certain blood cancers, and the trial includes participants who may have received this medicine before or who are being followed while on it. The study helps monitor how safe it is when used over a longer period.

  • Dasatinib

    is an oral treatment used for some types of leukemia. In this trial, it is one of the active medicines that participants may have been receiving in parent studies before rolling over into this long-term safety study. Its role here is to continue treatment and watch for side effects during ongoing use.

  • Imatinib

    is an oral medicine used to treat certain blood cancers. It is included as an active treatment option in the study for participants who were already taking it in earlier studies. The trial follows patients who stay on this medicine to better understand its long-term safety and tolerability.

  • Bosutinib

    is an oral cancer medicine that may be used in people with certain leukemia types. It appears in the study as another active treatment that participants may continue from a previous trial. The study is not testing whether it works better, but rather tracking safety while treatment continues over time.

What is already known about the treatment

  • Asciminib hydrochloride

    Asciminib hydrochloride is taken by mouth as a tablet or capsule and swallowed whole, usually once or twice daily as directed by the study team. It is a newer cancer medicine used mainly for chronic myelogenous leukemia, especially when the disease has a Philadelphia chromosome, and it is also discussed in medical literature for some related blood cancers. It belongs to a group of targeted cancer medicines called tyrosine kinase inhibitors, and it works by blocking the BCR-ABL1 protein at a special site, which helps stop the leukemia cells from growing and surviving.

  • Nilotinib

    Nilotinib is an oral medicine given as hard capsules that are swallowed whole, usually twice a day on an empty stomach. It is an established and widely used treatment in medical practice and literature for chronic myelogenous leukemia with the Philadelphia chromosome. It is a targeted cancer drug called a tyrosine kinase inhibitor, and it works by blocking the BCR-ABL protein inside leukemia cells, which slows or stops their growth.

  • Dasatinib

    Dasatinib is taken by mouth as a tablet and swallowed whole, usually once daily. It is a well-known medicine in current medical use and research for chronic myelogenous leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia. It belongs to the tyrosine kinase inhibitor group and works by blocking several signals, including BCR-ABL, that cancer cells need to grow and spread.

  • Imatinib

    Imatinib is an oral medicine taken as a tablet or capsule and swallowed with water, usually once daily or as prescribed. It is a long-established medicine in medicine and medical literature for chronic myelogenous leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia. It is a tyrosine kinase inhibitor that blocks the BCR-ABL protein, which helps stop leukemia cells from multiplying.

  • Bosutinib

    Bosutinib is taken by mouth as a tablet and swallowed whole, usually once daily with food as directed. It is an approved and well-described medicine in medical practice and literature for chronic myelogenous leukemia, especially when other similar treatments are not suitable or have stopped working. It is a tyrosine kinase inhibitor that blocks BCR-ABL and some related cell signals, reducing the ability of leukemia cells to grow.

Investigated diseases

Chronic myelogenous leukemia - A cancer of the blood and bone marrow that begins with too many immature white blood cells. It usually develops slowly at first, then can progress through a more active phase and, in some cases, to a more advanced phase with faster growth of abnormal cells. The disease may cause the bone marrow to make fewer normal blood cells over time. Philadelphia chromosome-positive acute lymphoblastic leukemia - A fast-growing cancer of the blood and bone marrow that starts from very early lymphoid cells. It develops quickly as abnormal cells build up and crowd out normal blood cells. The disease can worsen as these immature cells continue to multiply and spread within the marrow and blood.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507557-16-00Protocol codeCABL001A2001BEstimated enrolment462 patientsSponsorNovartis Pharma AG

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