Assessing long-term safety of asciminib therapy in Chronic Myelogenous Leukemia

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    What is this study about?

    This trial serves as a follow-up study for individuals who participated in a previous Novartis-sponsored investigation involving the medication asciminib. The primary objective is to monitor any potential long-term side effects that may arise in individuals who have continued taking Asciminib beyond the initial study. This global study is conducted across numerous hospitals and clinics and is characterized as ‘open-label,’ signifying that participants are aware that they are receiving asciminib. During each visit, the team will assess and record whether participants continue to experience benefits from asciminib.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Wien , Austria

      Varna , Bulgaria

      Ostrava , Czechia

      Brno-Bohunice , Czechia

      Copenhagen , Denmark

      Bordeaux , France

      Marseille , France

      Paris 10 , France

      Vandoeuvre les Nancy , France

      Berlin , Germany

      Frankfurt , Germany

      Jena , Germany

      Milano , Italy

      Roma , Italy

      Napoli , Italy

      Krakow , Poland

      Warszawa , Poland

      Lisboa , Portugal

      Porto , Portugal

      Timisoara , Romania

      Sevilla , Spain

      Barcelona , Spain

      Hospitalet de LLobregat , Spain

      Bilbao , Spain

      Madrid , Spain

      Madrid , Spain

      Valencia , Spain

      Oxford , United Kingdom

      You can join this study in:

      Spain: Barcelona, Bilbao, Madrid.

      Germany: Berlin, Frankfurt, Jena.

      France: Bordeaux, Marseille.

      Denmark: Copenhagen.

      Czechia: Ostrava.

      United Kingdom: Oxford.

      Portugal: Porto.

      Bulgaria: Varna.


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      Here’s a more detailed description of the study steps from a patient’s perspective:

        1. Initial Assessment: Patients are first evaluated to confirm they are suitable for continued treatment based on their previous response and health condition.
        2. Consent: Patients provide their consent to continue treatment with Asciminib, understanding the objectives and potential risks.
        3. Treatment Administration: Participants receive the medication either alone or with other drugs, depending on their specific medical needs.
        4. Regular Monitoring: Regular health check-ups are scheduled to monitor the effectiveness of the treatment and to check for any side effects.
        5. Adjustments if Necessary: The treatment plan may be adjusted based on the patient’s ongoing response and side effects.
        6. Long-Term Follow-Up: Patients will be followed for a long period to assess long-term safety and benefits, contributing to the understanding of the drug’s effects over time.

      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to have one of the following diseases:

      1. Chronic Myelogenous Leukemia (CML)
      2. Acute Lymphoblastic Leukemia (ALL)

      Additionally, you must already be receiving treatment with asciminib (either as a single agent or in combination with imatinib, nilotinib, or dasatinib), imatinib, nilotinib, or bosutinib alone within a Novartis-sponsored study and, in the opinion of the Investigator, would benefit from continued treatment.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      To join the study, you must meet the following inclusion criteria:

      1. Diagnosis: You must have Philadelphia chromosome-positive (PH+) Chronic Myeloid Leukemia (CML) or PH+ Acute Lymphoblastic Leukemia (ALL). The Philadelphia chromosome is an abnormality in chromosome 22, which is seen in these types of leukemia.
      2. Current Treatment: You are currently receiving treatment with asciminib (either as a single agent or in combination with other specified drugs), imatinib, nilotinib, or bosutinib alone as part of a Novartis-sponsored study. These are all targeted therapies used to treat certain kinds of leukemia.
        • Asciminib: It is a type of targeted therapy known as a tyrosine kinase inhibitor (TKI). It blocks a protein that promotes the growth of abnormal cells.
        • Imatinib: This is also a TKI that targets the bcr-abl tyrosine kinase protein caused by the Philadelphia chromosome.
        • Nilotinib: Similar to imatinib, nilotinib is a TKI used specifically to target the bcr-abl protein.
        • Bosutinib: Another TKI that targets the bcr-abl protein, used in the case resistance or intolerance to prior therapy.
      3. Investigator’s Opinion: The Investigator must believe that you would benefit from continued treatment.
      4. Previous Study Compliance: You have shown compliance with the parent study protocol and are willing and able to adhere to scheduled visits, treatment plans, and any other study procedures.

      What Reasons Could Exclude Me from the Study?

      Here is the list of conditions under which you cannot take part in the study:

      1. Discontinued from parent study treatment: If you have been removed from the initial (parent) study.
      2. Unresolved toxicities: If you have ongoing harmful effects from the treatment in the parent study that have not been resolved.
      3. Treatment approved and reimbursed: If the treatment you’re receiving is already approved and covered by healthcare reimbursement in your country.
      4. Pregnant or nursing women: If you’re currently pregnant or breastfeeding.
      5. Women of child-bearing potential not using contraception: If you are able to become pregnant and are not using effective birth control methods.
      6. Sexually active males not following contraception requirements: If you are a sexually active male patient receiving imatinib, nilotinib, bosutinib, or dasatinib and unwilling to adhere to contraception guidelines provided in the local prescribing information.
      7. Conditions specific to bosutinib-treated participants switching to asciminib:
        • Asymptomatic pancreatitis: Pancreatic inflammation without symptoms.
        • Abnormal ECG: Irregularities in the heart’s electrical activity as detected by an electrocardiogram.
        • Grade 3 or 4 toxicity: Severe adverse reactions from treatment that have not improved to a moderate level within 28 days before starting asciminib treatment.

      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The clinical trial involves the following drugs:

      1. Asciminib (active substance)
        • Described as being taken orally, either twice daily in a fasting state or once daily with a low-fat meal for the combination therapy.
      2. Imatinib (active substance, trade name STI571)
        • Taken orally, once daily in the morning with a low-fat meal.
      3. Nilotinib (active substance, trade name AMN107)
        • Taken orally, twice daily on an empty stomach.
      4. Bosutinib (active substance)
        • Taken orally, once daily, with food.
      5. Dasatinib (active substance, trade name Sprycel)
        • Taken orally, once daily in a fasted state, 1 or 2 hours before a meal.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      1. Asciminib: A STAMP (Specifically Targeting the ABL Myristoyl Pocket) inhibitor, a new class of precision medicines that bind to the myristoyl site of BCR-ABL1. It is designed to inhibit the activity of the BCR-ABL1 protein.
      2. Imatinib: A tyrosine kinase inhibitor that specifically targets certain tyrosine kinases, including the BCR-ABL1 protein, which promotes the growth of abnormal cells.
      3. Nilotinib: Another tyrosine kinase inhibitor, it is similar to imatinib but has increased potency and selectivity for the BCR-ABL1 protein.
      4. Bosutinib: It is also a tyrosine kinase inhibitor but has a slightly different binding profile compared to imatinib and nilotinib, aiming at various oncogenic Src-family (Src, Lyn, Hck) and Abl kinases.
      5. Dasatinib: It is a potent and broad-spectrum tyrosine kinase inhibitor with activity against BCR-ABL1 and Src kinase family, which has shown efficacy in patients resistant or intolerant to imatinib.

      Study ID

      CT-EU-00041585

      Recruitment status

      Recruting new patients

      Start of the trial

      2 years ago