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 have been newly diagnosed with acute myeloid leukemia (AML) — a type of blood cancer — who have not yet received treatment for it, and whose doctors have determined that standard intensive chemotherapy is not suitable for them due to their age or other health conditions. Limited prior use of hydroxyurea or a very small emergency dose of cytarabine is allowed.
• People aged 18 or older who are either: 60 years of age or older; under 60 but considered by their doctor to be unsuitable for standard intensive chemotherapy due to other health conditions; or who have chosen not to receive standard intensive chemotherapy.
• People whose liver is functioning adequately, meaning bilirubin, AST, and ALT blood test results fall within specified ranges (unless abnormal results are determined by the treating doctor to be caused by the leukemia itself).
• People whose kidneys are functioning adequately, based on a blood test result (creatinine) within a specified range.
• People with a general health and activity level rated at 0, 1, or 2 on a standard medical scale (ECOG), meaning they are able to carry out at least some daily activities (confirm with trial site).
• Women who could potentially become pregnant must have a negative pregnancy test within one week before joining the trial.
• People who are able to understand what the study involves and who have signed a consent form agreeing to take part (this can also be signed by a legally authorised representative).
• People whose doctors estimate they are likely to live for at least 12 weeks.

Who may not be able to join:

• People who have had another type of cancer before joining the trial, unless it was: an early-stage cervical or breast cancer that was adequately treated; a skin cancer (basal cell or localised squamous cell); or a previous cancer that was fully removed or treated with the intention of curing it.
• People whose AML is a specific subtype called acute promyelocytic leukemia, or who have a history of certain blood or bone marrow disorders, including myelofibrosis, essential thrombocythemia, polycythemia vera, or chronic myeloid leukemia (CML), or whose AML involves a specific genetic marker (BCR-ABL positive).
• People whose AML has spread to the central nervous system (the brain and spinal cord).
• People with a white blood cell count above a certain level (though a medication called hydroxyurea may be used to bring this down before eligibility is assessed).
• People who have previously been treated with certain medicines including venetoclax, cladribine, hypomethylating agents (such as azacitidine or decitabine), chidamide, or CAR-T cell therapy, or who have received experimental treatments for related blood conditions.
• People who have a condition that prevents them from taking medicines by mouth or through the digestive system.
• People who are known to be HIV positive.
• People who have taken certain medicines known as strong or moderate CYP3A inducers within the 7 days before starting the study treatment (confirm with trial site for a list of these medicines).
• People who have eaten grapefruit, grapefruit products, Seville oranges (including marmalade made with Seville oranges), or starfruit within 3 days before starting the study treatment.
• People with heart disease that causes symptoms — such as fatigue, shortness of breath, or chest pain — during ordinary, everyday activities, or that is more severe than this.
• People with a chronic lung condition requiring continuous oxygen, or significant ongoing problems with the kidneys, nervous system, mental health, hormonal system, metabolism, immune system, liver, or heart, that in the opinion of the study doctor could affect safe participation in the trial.
• People with a significant active infection (viral, bacterial, or fungal) that is not controlled.
• People known to be positive for hepatitis B or C, unless the virus has been undetectable in blood tests within the past 3 months, or unless blood tests show evidence of prior vaccination against hepatitis B.

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