Phase 3 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 diagnosed with acute myeloid leukemia (AML) according to World Health Organization 2022 criteria, but not certain specific subtypes (see exclusions below)
• People whose AML falls into the "AML without separate classification" category under WHO guidelines, and not the type involving widespread bone marrow scarring or tumours outside the bone marrow
• People aged 16 to 64 years old (male or female) who are newly diagnosed with AML and are considered well enough to receive intensive chemotherapy
• People whose general health and ability to carry out daily activities is rated at a certain level (scored 0–2 on a standard medical scale, meaning they are not completely disabled)
• People who have not previously received treatment for AML, except for specific low-dose medications sometimes used briefly to manage high white blood cell counts
• People whose recent blood tests (taken within 7 days before starting treatment) show liver function, kidney function, and heart enzyme levels within acceptable ranges
• Women of childbearing age who have a negative pregnancy test within 72 hours before starting treatment, are not planning to become pregnant during the study or for 6 months after the last dose, and agree to use appropriate contraception
• Men who agree to use a latex condom during any sexual contact with a woman who could become pregnant, even after a vasectomy, and agree to avoid fathering a child during treatment and for 6 months after the last dose
• People with a life expectancy of more than 2 months
• People (or their legal guardian or close family member) who are able to sign an informed consent form before any study procedures begin

Who may not be able to join:

• People whose AML involves a specific genetic change called BCR-ABL1, or people whose chronic myeloid leukaemia (CML) has progressed to a crisis phase
• People who have already received induction (intensive) chemotherapy for AML, regardless of how well it worked
• People whose condition is classified as acute widespread bone marrow disease with scarring, or leukaemia that has formed tumours outside the bone marrow (myelosarcoma), as defined by WHO 2016
• People whose leukaemia developed as a result of previous cancer treatment, or who have a history of certain pre-leukaemia bone marrow conditions (MDS or MPD)
• People with certain other blood disorders (such as haemophilia or bone marrow scarring) that make participation unsuitable (confirm with trial site)
• Women who are pregnant or breastfeeding
• People who are known to be allergic to any of the medications used in this trial
• People who have taken certain medications that strongly or moderately affect how the body processes drugs (CYP7A inducers) within 3 days before starting the study treatment (confirm with trial site)
• People who currently have another type of cancer that requires active treatment
• People whose liver or kidney function test results fall outside the acceptable ranges set for joining the trial
• People with serious active heart conditions, including: a heart attack within the past 6 months; a history of irregular heartbeat requiring medication or causing serious symptoms; uncontrolled or symptomatic heart failure; uncontrolled or symptomatic chest pain (angina); or reduced heart pumping function below the normal range
• People with serious active infections such as untreated tuberculosis, a lung fungal infection (aspergillosis), known HIV infection, or active hepatitis B or C; or people with any infection that cannot be controlled
• People who show signs of leukaemia affecting the brain or spinal fluid before treatment begins
• People with epilepsy, dementia, or other significant mental health conditions requiring medication that would prevent them from understanding or following the study requirements
• People who are unable to swallow oral medications or whose body cannot properly absorb medications taken by mouth
• People whom the trial investigators consider unsuitable for participation for any other reason

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