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:

• People who have been diagnosed with acute myeloid leukemia (AML) according to a specific international classification system (WHO 2016)
• People whose AML has a specific genetic change called a FLT3 mutation, detected at certain levels in testing
• People whose AML either did not respond to their first round of intensive chemotherapy, or whose AML has come back after first-line treatment (either intensive or non-intensive chemotherapy)
• People whose first-line treatment may or may not have included a type of targeted drug called a tyrosine kinase inhibitor (TKI), as long as it was not gilteritinib
• People who have never been treated with oral azacitidine
• People aged 18 or older
• People whose kidneys, liver, and heart are functioning at levels that meet specific minimum thresholds set by the trial
• People with a general health and activity level rated below a certain threshold on a standard scale (ECOG score less than 3), meaning they are able to carry out at least some daily activities (confirm with trial site)
• People without psychological, family, social, or location-related circumstances that would make it difficult to follow the trial schedule
• People who are able to swallow and take oral (by mouth) medication
• Women who are not pregnant, and who are either past menopause (at least one year without a period) or have been surgically sterilised, OR women of childbearing potential who agree to use contraception from screening through to at least 180 days after the last dose of study drug
• Women who agree not to breastfeed from screening through to at least 60 days after the last dose of study drug
• Women who agree not to donate eggs from screening through to at least 180 days after the last dose of study drug
• Men with female partners who could become pregnant, who agree to use contraception from screening through to at least 120 days after the last dose of study drug
• Men who agree not to donate sperm from screening through to at least 120 days after the last dose of study drug
• People enrolled in the French social security (health insurance) system
• People who have given signed written consent to participate in the trial

Who may not be able to join:

• People whose AML developed from a prior blood disorder called myeloproliferative syndrome
• People with specific subtypes of AML known as acute promyelocytic leukemia (APL) or core binding factor (CBF) AML
• People with certain inherited conditions affecting DNA or bone marrow function
• People with a condition called blastic plasmacytoid dendritic cell neoplasm
• People with acute lymphoblastic leukemia or a leukemia that has features of more than one blood cell type
• People who have already had two or more lines of AML treatment (note: a stem cell transplant is not counted as a line of treatment)
• People who have previously been treated with azacitidine as a single drug for AML
• People who have previously been treated with gilteritinib
• People who have previously been treated with oral azacitidine
• People with leukemia that is currently active in the central nervous system (brain or spinal cord)
• People who have had more than one prior stem cell transplant from a donor
• People whose AML relapsed within 100 days of a donor stem cell transplant
• People with moderate to severe graft-versus-host disease (a complication of donor stem cell transplants), or whose treatment for this condition was recently escalated
• People who need to take certain medications that strongly affect how the body processes drugs (strong CYP3A inducers or certain P-glycoprotein inhibitors/inducers), unless those medications are considered absolutely essential
• People with severe liver disease, such as cirrhosis or certain other serious liver conditions
• People with a significant abnormality in blood clotting, such as a condition called disseminated intravascular coagulation (DIC)
• People with a serious, uncontrolled infection (viral, bacterial, or fungal) at the time of joining
• People whose leukemia has relapsed only in areas outside the bone marrow (isolated extramedullary relapse)
• People who have had another cancer within the past 3 years, except for certain early-stage skin or cervical cancers
• People with other serious medical, laboratory, or psychiatric conditions that the trial team considers would put them at unacceptable risk or prevent them from giving informed consent
• People whose other health conditions are considered incompatible with intensive chemotherapy (to be reviewed and approved by the study's medical monitor)
• People who are deprived of liberty by a legal or administrative decision, or who are under legal protection measures such as guardianship (specific to French legal context)
• People with a confirmed positive HIV test, or known active hepatitis B or C infection (note: people who are inactive carriers with undetectable virus levels on antiviral treatment may not be excluded — confirm with trial site)
• People with a known allergy or hypersensitivity to the study medication
• People with severe heart failure (classified as New York Heart Association Class III or IV), unless a recent heart scan shows the heart is pumping at an acceptable level
• People with a corrected heart rhythm measurement (QTcF) above a certain threshold on a heart tracing (ECG) taken at screening
• People with a personal history of a heart condition called Long QT Syndrome

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