Phase 3 Leukaemia Trial, Recruiting

Written by an AI model from 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 diagnosed with a specific type of blood cancer called Philadelphia chromosome-positive Chronic Myeloid Leukemia (CML) in its chronic (early) phase, whose previous treatment with targeted therapy drugs (including one called Imatinib) either stopped working or caused intolerable side effects
• People who are well enough to carry out light daily activities (based on a standard health performance scale rated 0, 1, or 2)
• People whose blood and bone marrow test results meet specific thresholds showing the disease is still in its early phase — including low levels of certain abnormal cells and a platelet count that is generally at or above a certain level (confirm with trial site for exact thresholds)
• People whose liver, kidneys, and pancreas are functioning well enough based on specific blood test results
• Women who could become pregnant must have a negative pregnancy test within 14 days of joining the trial
• Women who could become pregnant must agree to use adequate contraception throughout the trial and for at least one month after the last dose of the study drug

Who may not be able to join:

• People whose CML has ever progressed to a more advanced stage (called accelerated phase or blast crisis), even if this happened only once during previous treatment
• People whose leukemia is already showing a complete response at the chromosome level at the time of screening
• People with certain heart problems, including reduced heart pumping function, certain abnormal heart rhythms, a pacemaker, a history of long QT syndrome (a heart electrical condition) in themselves or their family, a history of heart attack or unstable chest pain in the last 12 months, a resting heart rate below 50 beats per minute, or other significant heart conditions
• People whose cancer has a specific genetic mutation called T315I
• People whose leukemia has spread to the central nervous system (brain and spinal cord), confirmed by laboratory testing
• People with severe or uncontrolled ongoing illness
• People with a significant history of bleeding disorders unrelated to their leukemia
• People who have previously had radiotherapy covering 25% or more of the body, particularly areas with a high proportion of bone marrow
• People who have had major surgery within 4 weeks before starting the study drug, or who have not fully recovered from a previous surgery
• People currently taking part in another clinical trial and receiving another experimental treatment
• People who are unable to give informed consent to participate in the trial
• People with another significant active cancer diagnosis at the same time
• People currently taking certain strong medications that affect how the liver processes drugs (called strong CYP3A4 inhibitors or inducers) or blood-thinning medications called coumarin derivatives, if those medications cannot be stopped or switched before starting the study drug
• People currently taking medications known to affect heart rhythm in a specific way (QT prolongation), if those cannot be stopped or switched before starting the study drug
• People with stomach or intestinal conditions that may significantly affect how the study drug is absorbed
• People with a history of acute or chronic pancreas inflammation (pancreatitis) within the past year
• People with active liver, pancreas, or severe kidney disease that is not caused by their leukemia
• People who test positive for HIV, have active hepatitis B or C, or have liver cirrhosis (note: people who are inactive carriers of hepatitis B, or who have stable or cured hepatitis B or C under certain conditions, may still be eligible — confirm with trial site)
• Women who are pregnant, breastfeeding, or unwilling to use adequate contraception during the trial
• Men who are unwilling to use adequate contraception during the trial
• People with a known allergy or sensitivity to the study drug or any of its ingredients

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