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 willing and able to sign a consent form agreeing to take part in the study
• People who are willing to follow all study procedures and are available for the full duration of the trial
• People whose general health and ability to carry out daily activities meets a certain level (an ECOG score of 2 or lower, meaning they are at least partially able to care for themselves — confirm with trial site)
• People who have a specific type of blood cancer called AML (not the M3 subtype) that has a particular genetic change called FLT3-ITD or FLT3-TKD, and whose cancer has either come back at least once or has not responded to at least one prior treatment for AML
• People whose FLT3 genetic mutation has been confirmed by testing at the time their disease came back
• People whose liver, kidneys, and other organs are functioning well enough to participate (confirm with trial site)
• People whose heart is pumping blood effectively — specifically, with a heart pumping function (ejection fraction) of 50% or more
• People who have received no more than a certain cumulative amount of a type of chemotherapy called anthracyclines (up to 368 mg/m² of daunorubicin or an equivalent amount of a similar drug)
• People who are able to swallow tablets or capsules and are willing to follow the medication schedule
• Women who could become pregnant must agree to use highly effective contraception, such as two barrier methods used together, hormonal contraceptives (pill, injection, or implant), an intrauterine device (IUD), or tubal ligation
• Women who could become pregnant must have a negative pregnancy test (blood or urine) within 10 days before starting treatment, and again within 24 hours before the first dose
• Men who could father a child must agree to use condoms during the study
• Women who are breastfeeding must agree to stop nursing for the duration of the study
• People who have had a stem cell transplant from a donor and whose AML has since come back must have any graft-versus-host disease (a complication where donor cells attack the body) that is mild and well controlled (grade 2 or lower), and if taking certain anti-rejection medications (tacrolimus or sirolimus), the dose must be stable or being gradually reduced

Who may not be able to join:

• People who are currently taking part in another clinical trial involving an experimental treatment
• People whose AML has spread to the brain or spinal fluid
• People whose AML continued to get worse while they were being treated with a drug called gilteritinib
• People who have a condition affecting the stomach or intestines that could interfere with how oral medications are absorbed
• People who have had major surgery within two weeks before starting the study, or who have not yet fully recovered from surgery performed more than two weeks ago
• People whose white blood cell count is 50,000 or higher at the time treatment would begin (note: a medication called hydroxyurea may be used to bring the count below this level before treatment starts)
• People whose overall health means they are unlikely to be able to tolerate standard intensive chemotherapy
• People with serious uncontrolled health conditions, such as an active infection, severe heart failure, unstable chest pain, an uncontrolled irregular heartbeat, or mental health or personal circumstances that would make it difficult to follow the study requirements
• People who have another type of cancer that currently requires treatment — with some exceptions: skin cancers (basal cell or squamous cell), early-stage cervical or breast cancer that has not spread (carcinoma in situ), or a history of breast cancer currently managed with hormone-based maintenance therapy may still be eligible (confirm with trial site)
• People who have had a stem cell transplant from a donor and have moderate-to-severe graft-versus-host disease (grade 3 or higher), or who are taking steroid medications to treat graft-versus-host disease

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