Phase 1 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 are 18 years of age or older.
• People who have voluntarily signed a consent form agreeing to take part in the study.
• People whose doctors expect them to live for more than 12 weeks.
• People diagnosed with advanced acute myeloid leukemia (AML) — including certain related types — according to 2022 medical diagnostic standards, where standard treatments have not worked, were not tolerated, or (in one part of the study) could not be accessed for various reasons.
• People whose general physical fitness falls within a certain range on a standard medical scale (ECOG score of 0 to 2, meaning able to carry out daily activities with little to no limitation — confirm with trial site).
• People who are willing to have bone marrow samples taken during the study to check how the treatment is working.
• People whose recent blood test results meet specific requirements within 7 days before the first dose, including: white blood cell count at or below a certain level; liver enzyme levels within acceptable limits; kidney function above a minimum threshold; and other blood chemistry values within set ranges (confirm specific values with trial site).
• People whose side effects from previous cancer treatments have mostly cleared up (grade 1 or lower), apart from hair loss or skin darkening.
• People who are willing and able to follow the study schedule and all other study requirements.
• Women who could become pregnant must have a negative blood pregnancy test at screening.
• Women who could become pregnant, and men whose partners could become pregnant, must use a highly effective form of contraception from screening until 180 days after the last dose.
• People who have had FLT3 gene mutation testing within the past 6 months, or who are willing to have this test done during the screening period.

Who may not be able to join:

• People who have a known allergy to any ingredient in the study drug.
• People diagnosed with a specific type of leukemia called acute promyelocytic leukemia (APL).
• People with a type of leukemia that is BCR-ABL positive (a specific genetic marker associated with chronic myelogenous leukemia in an acute phase).
• People whose AML developed as a result of previous cancer treatment for a different cancer (except when it developed from certain blood disorders called MDS or MDS/MPN).
• People who have leukemia that has spread to the central nervous system (brain and spinal cord) and is causing symptoms.
• People who are currently enrolled and receiving treatment in another clinical trial within 28 days before the first dose (people in a survival follow-up phase of another study may still be eligible — confirm with trial site).
• People who have received cancer treatments such as chemotherapy, immunotherapy, targeted therapy, or similar treatments within 28 days or 5 half-lives (whichever is shorter) before the first dose; or radiotherapy within 14 days before the first dose; or herbal medicines approved for cancer treatment within 7 days before the first dose.
• People who have moderate to severe graft-versus-host disease (a complication that can occur after a stem cell transplant), or who have been receiving certain medications to treat this condition within 14 days before the first dose.
• People who have received a type of immune cell therapy called CAR-T cell therapy within 3 months before the first dose.
• People taking certain strong medications that significantly affect how the body processes drugs (strong CYP2C8 or CYP3A4 inhibitors or inducers) within 14 days before the first dose, unless the treating doctor considers them essential.
• People who have had major surgery within 28 days, or minor surgery within 7 days, before the first dose (excluding diagnostic biopsies or placement of a vascular access device).
• People with significant blood clotting disorders such as disseminated intravascular coagulation (DIC), haemophilia A, haemophilia B, or vascular haemophilia.
• People with persistently low potassium or magnesium levels in the blood that are difficult to correct and have recurred on multiple occasions.
• People with active tuberculosis, or lung conditions such as interstitial lung disease (including drug-related or radiation-related lung inflammation) that require steroid treatment or are currently active.
• People with an uncontrolled active infection (meaning ongoing signs of infection that have not improved with appropriate treatment) within 72 hours before the first dose. Preventive use of antibiotics, antifungals, or antivirals does not exclude someone from joining.
• People who are unable to swallow tablets or capsules, or who have had surgery or serious digestive conditions (such as severe difficulty swallowing or an active stomach ulcer) that the treating doctor believes could affect how the body absorbs the study drug.
• People who have had a serious blood clot — such as deep vein thrombosis or pulmonary embolism — within 3 months before the first dose (clots related to vascular access devices or surface veins are exceptions — confirm with trial site).
• People with active or uncontrolled hepatitis B, hepatitis C, or HIV infection, based on specific test results.
• People with a significant history of heart or cardiovascular problems, including: severe heart failure within the past 6 months; unstable chest pain (unstable angina) within the past 6 months; a heart attack within the past 6 months; poorly controlled irregular heart rhythms; a diagnosed or suspected condition causing abnormally long heart electrical signals (long QT syndrome, including a family history); certain abnormal heart electrical readings above set thresholds; reduced heart pumping function below a set level; high blood pressure that remains uncontrolled despite multiple medications; or a stroke or mini-stroke within the past 6 months.
• People who are currently pregnant or breastfeeding.
• People with serious active mental health conditions or other medical or personal circumstances that, in the treating doctor's judgement, could interfere with participation, following study requirements, or the ability to give informed consent.

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