Phase 1 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:

• People who are 18 years of age or older at the time of signing the consent form
• People who are willing and able to understand and sign a consent form before any study-related activities begin
• People who are able and willing to attend study visits and follow the study schedule and requirements
• People who have a confirmed diagnosis of acute myeloid leukaemia (AML) — either a new diagnosis or AML that developed from a condition called MDS — or a confirmed diagnosis of high-risk MDS (HR-MDS), based on 2022 WHO classification standards
• People whose AML or HR-MDS has returned or stopped responding to treatment, and who have either tried all available treatments or are not eligible for them
• People whose blood and organ function test results meet specific levels set by the trial, including white blood cell count, liver enzymes, bilirubin, kidney function, and blood clotting measures (confirm with trial site)
• People who are expected to live for at least 12 weeks
• People who have a general health and activity level rated at 0, 1, or 2 on a standard medical scale, meaning they are able to carry out at least some daily activities (confirm with trial site)
• Women who could become pregnant must have a negative pregnancy test at the screening stage and again on the first day of treatment

Who may not be able to join:

• People who have a specific type of leukaemia called acute promyelocytic leukaemia (APML)
• People whose leukaemia has spread to the brain or spinal cord
• People who have received cancer treatments within a certain period before starting the trial — generally within 28 days or based on how long the previous treatment stays active in the body
• People who still have significant side effects (grade 2 or higher) from previous cancer treatments, except for hair loss
• People who have chronic graft versus host disease (a condition that can occur after a stem cell transplant) that requires ongoing medication to suppress the immune system
• People who have another active cancer other than AML or MDS
• People who have had major surgery within 4 weeks before the first dose of the study drug
• People who have severe, life-threatening complications from leukaemia, such as an uncontrolled infection, uncontrolled bleeding, or a serious blood clotting disorder
• People who have a known ongoing infection with hepatitis B, hepatitis C, or HIV
• People who are unable to swallow tablets or capsules, or who have significant digestive problems such as diarrhoea, vomiting, or difficulty absorbing medications taken by mouth
• People with significant other medical conditions, laboratory results, or mental health conditions that the trial team considers would put them at unacceptable risk or prevent them from participating properly (confirm with trial site)
• People who are taking certain medications or supplements that are known to strongly or moderately affect how the body processes the study drug, within a set period before starting treatment (confirm with trial site for specific medications)
• People who are pregnant or breastfeeding

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