Phase 2 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:

• Adults aged 18 or older who have been diagnosed with a blood cancer involving a specific gene change called a FLT3 mutation (either FLT3-ITD or FLT3 D835 type), including certain types of leukaemia (AML) or related blood disorders (CMML or other MDS/MPN conditions rated as intermediate-2 or high-risk).
• People whose cancer has come back or stopped responding to previous treatment (for the Phase I and Phase II cohort B groups), or people who have been newly diagnosed with FLT3-mutated AML and have not yet received AML treatment (for Phase II cohort A).
• People whose general physical functioning is rated at level 3 or better on a standard medical scale, meaning they are able to care for themselves at least some of the time (confirm with trial site).
• People whose liver test results (bilirubin, ALT, and AST) are within acceptable ranges, unless certain known conditions explain the higher levels and the lead doctor approves.
• People whose kidneys are working at a sufficient level, measured by a creatinine clearance of at least 30 mL/min.
• People who are able to swallow oral medication.
• People who are willing and able to give written informed consent to participate.

Who may not be able to join:

• People in Phase II cohort A who have previously received treatment specifically for AML (though prior treatment for a related blood disorder, or short-term use of certain medicines like hydroxyurea or cytarabine for cell reduction, may be allowed — confirm with trial site).
• People in Phase II cohort A who are considered suitable for and willing to receive standard intensive chemotherapy.
• People with a inherited heart condition causing a long QT interval, or whose heart rhythm measurement (QTcF) is greater than 450 milliseconds — though repeat testing after correcting certain factors may still allow eligibility in some cases (confirm with trial site).
• People with a serious active infection that is not being controlled by antibiotics.
• People with active severe heart failure (grade III–V as defined by a standard heart failure scale).
• People with leukaemia that has spread to the brain or spinal cord (central nervous system).
• People who are known to be HIV positive.
• People who have active hepatitis B or a suspected active hepatitis C infection (though in some specific circumstances, people with certain hepatitis B or C antibody results and an undetectable viral load may still be considered — confirm with trial site).
• People with another cancer whose history or treatment could interfere with the study results (though in some cases this may be discussed with the lead doctor — confirm with trial site).
• People who have taken certain strong medications (known as strong CYP3A or p-glycoprotein inducers, such as carbamazepine, phenytoin, rifampin, or St. John's wort) within 3 days of joining the study.
• People who have received other experimental leukaemia treatments or chemotherapy within 7 days before joining the study, unless side effects have fully resolved or the disease is rapidly worsening in a life-threatening way (some exceptions apply — confirm with trial site).
• People who are pregnant — a negative pregnancy test is required before joining, and effective contraception must be used throughout the study and for at least 6 months after the last dose of study medication.
• People who are breastfeeding or planning to breastfeed during treatment or for at least 2 months after the last dose of one of the study drugs (gilteritinib).
• Male participants are required to use effective birth control throughout the study and for at least 4 months after the last dose, to protect any partner who could become pregnant.

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