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:

• People who are already enrolled in the related CHIP-AML22/Master trial before joining this one
• People whose leukaemia cells test positive for a specific gene change called FLT3-ITD, and do not have a change in another gene called NPM1, confirmed through standard lab tests before treatment begins
• Children and young people aged 1 month to 18 years old at the time of diagnosis
• People with a physical functioning score above 50% on age-appropriate medical scales (one scale is used for those older than 16, another for those 16 and under)
• People whose kidneys are working well enough before chemotherapy starts, based on a calculated kidney function score of at least 50 mL/min/1.73m²
• People whose liver is working well enough before chemotherapy starts, with specific blood test results within acceptable ranges
• People with a life expectancy of more than 6 weeks
• Girls who have started their periods must have a negative pregnancy test (blood or urine) within 2 weeks before joining this part of the trial
• People who are able to swallow the study drug (quizartinib) reliably, or receive it through a tube into the stomach
• People (or their parents or legal guardians, for those under 18) who have given written agreement to take part, in line with local laws

Who may not be able to join:

• People whose leukaemia is only found outside the bone marrow, with no bone marrow involvement
• People with serious or uncontrolled heart conditions, including a diagnosed or suspected inherited heart rhythm disorder (long QT syndrome), a history of dangerous irregular heartbeats, a corrected heart rhythm measurement (QTcF) above 450ms (for those aged 6 and over), reduced pumping function of the heart (ejection fraction below 55%), uncontrolled chest pain or a heart attack within the past 6 months, a history of certain types of heart block (except people with pacemakers who have no history of fainting or relevant irregular heartbeat), a resting heart rate below 50 beats per minute, persistently high blood pressure above the 95th percentile for their age, sex and height, a history of complete left bundle branch block, or a history of severe heart failure (Class 3 or 4)
• People with a known history of HIV, or active hepatitis B or C infection
• People with a gut or digestive condition that could affect how the body absorbs the study drug
• People taking certain medications that strongly or moderately affect how the body processes drugs (known as strong or moderate CYP3A inducers) — these are not permitted during the trial
• People with a known allergic reaction to any of the study medications or their ingredients
• People with other serious health conditions that would likely make it impossible to complete the trial treatment safely
• People currently taking part in another experimental treatment trial, if that trial would interfere with this one's measurements or outcomes
• During an early safety phase of the trial only: people with leukaemia that has spread to the fluid around the brain and spine (called CNS3 disease)
• During the early safety phase only: people taking strong CYP3A4 inhibitors — though if a person is able to stop taking them, joining may still be possible without a waiting period (confirm with trial site)

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