Phase 4 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:

• People who have been diagnosed with a specific type of blood cancer called AML (but not the subtype known as Acute Promyelocytic Leukaemia, and not a type with a FLT3 gene mutation), confirmed through laboratory testing
• People whose AML is currently in remission (cancer not detectable) after completing induction and consolidation treatment, as determined by their treating doctor
• People in their first remission whose AML is considered intermediate or high risk, or who still have detectable disease markers, or who cleared disease slowly — or people in their second or later remission with any eligible AML subtype
• People whose doctors (treating or transplant physician) consider them medically suitable for a stem cell transplant from a donor, or who score 5 or less on a standard medical fitness scale for transplant
• People aged 18 years or older
• People who enrol within 4 months of finishing their cancer treatment
• People who have at least one identified social or life circumstance that may create challenges, such as financial difficulties, lack of a carer, difficulty understanding medical information, living in a rural area, limited access to healthcare, lack of a suitable stem cell donor, or substance use issues
• People whose kidneys, liver, and other organs are functioning at an adequate level based on specific blood test results (confirm with trial site for exact values)
• People with a functional status score of 0, 1, 2, or 3 on a standard scale used to measure how much a person's daily activities are affected by their illness
• People who are able to swallow and take oral (by mouth) medications
• People who do not have a condition that significantly prevents the body from absorbing oral medications
• Women who could become pregnant must agree to use effective contraception during the study and for at least 6 months after the last dose
• Men must agree to use effective contraception during the study and for at least 3 months after the last dose
• People who are willing and able to give written informed consent to participate

Who may not be able to join:

• People whose AML has a FLT3 gene mutation (either ITD or TKD type)
• People with active, uncontrolled cancer involvement in the brain or spinal cord
• People who have had a known allergic or hypersensitivity reaction to a medicine called azacitidine or any of its ingredients
• People who have had a stem cell transplant within the 3 months before starting the study treatment
• People with an active, uncontrolled illness or infection
• People who have previously been treated with oral azacitidine
• Women who are pregnant, or who plan to become pregnant or donate eggs during the study or for 6 months after their last dose
• Men who plan to donate sperm during the study or within 3 months after their last dose
• People currently receiving treatment for another cancer (except for certain easily removable skin cancers)
• People with a medical, psychological, or social condition that, in the trial doctor's opinion, could increase risk or make it difficult to follow the study requirements

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