Phase 2 Leukaemia Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older
• People who are willing and able to give their formal agreement to take part in the trial
• People newly diagnosed with a type of blood cancer called chronic myeloid leukaemia (CML) in its early "chronic" stage, confirmed by a bone marrow test within the last 6 months, and with a specific form of the disease linked to a protein called p210 BCR::ABL1
• People who have had little or no prior treatment for CML with a targeted therapy called a TKI (no more than 30 days); some other chemotherapy medicines are allowed with no time restriction
• People whose general health and ability to carry out daily activities falls within an acceptable range as assessed by doctors (confirm with trial site)
• People whose liver function blood test results are within acceptable limits
• People whose kidneys are working at an adequate level based on a blood test
• People whose bilirubin (a liver-related substance in the blood) is within acceptable limits
• People whose blood pressure is adequately controlled, with a reading below 140/90 mmHg at the time of joining
• People whose blood test results for a pancreas-related enzyme (lipase) are within acceptable limits
• People whose blood test results for a muscle-related enzyme (creatine phosphokinase) are within acceptable limits
• Women who are post-menopausal for at least one year, surgically unable to have children, or — if able to become pregnant — committed to using two effective forms of contraception from the time of consent until 90 days after the last dose of the study drug, or to practising consistent abstinence as part of their usual lifestyle (note: methods such as calendar-based or withdrawal methods are not considered acceptable)
• Men — including those who have had a vasectomy — who agree to use effective barrier contraception throughout the study and for 90 days after the last dose, or to practising consistent abstinence as part of their usual lifestyle (note: calendar-based or withdrawal methods are not considered acceptable)

Who may not be able to join:

• People whose CML has progressed to a more advanced stage (accelerated or blast phase)
• People who currently have another active cancer requiring treatment
• People who have had a pancreas inflammation (pancreatitis) — either recently (within the past 12 months) or as an ongoing condition
• People who have previously been treated with the drug asciminib
• People whose blood cell counts (platelets, white blood cells, or red blood cells/haemoglobin) are below certain minimum levels
• People with certain heart conditions or abnormalities in how the heart's electrical activity is measured, including a heart attack, chest pain, or heart bypass surgery within the past 6 months; certain abnormal heart rhythms; abnormal electrical readings on a heart test (ECG) above set thresholds; or a condition called Long QT syndrome — or a family history of it (confirm specific details with trial site)
• People taking certain medications that affect how the heart's electrical system works and that cannot be safely swapped or stopped 7 days before starting the study drug (confirm with trial site)
• People who are pregnant or breastfeeding
• People taking certain medicines that strongly affect how the body processes drugs (known as strong CYP3A4 inhibitors, inducers, or certain narrow therapeutic index substrates) at the time of joining (confirm with trial site)
• People who are unable to keep scheduled blood test appointments or complete required self-reported questionnaires
• People who have taken part in another clinical drug trial within 4 weeks of joining
• People with a serious medical or psychiatric condition that, in the doctor's opinion, could interfere with completing the treatment as planned
• People who have previously had a bone marrow or stem cell transplant from a donor
• People with a known active hepatitis B (HBV) infection

Important: Always verify eligibility with the trial site directly before applying.