Phase 1 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 are able to understand the study, follow its procedures, and give informed consent before any study-related steps begin — including keeping to a specific blood-testing schedule during the first treatment cycle.
• People who have a confirmed cancer diagnosis, specifically: a solid tumour that has spread or cannot be surgically removed and for which no standard life-extending treatments are available; OR a blood cancer called AML (acute myeloid leukaemia) or MDS (myelodysplastic syndrome); OR another type of blood cancer for which no standard life-extending treatments are available.
• People with AML or MDS who have a diagnosis confirmed by lab testing (excluding a specific subtype called M3 acute promyelocytic leukaemia), and who either have newly diagnosed MDS or AML that is not suitable for standard intensive chemotherapy due to factors such as older age, poorer physical functioning, serious lung problems, or elevated liver markers — and who have blood counts (platelets and neutrophils) above certain minimum levels.
• People with other blood cancers or solid tumours who have platelet and neutrophil blood counts above certain minimum levels.
• People with a physical functioning level rated 0 to 3 on a standard cancer performance scale (meaning people range from fully active through to capable of limited self-care) (confirm with trial site).
• People whose liver function falls within one of three defined categories: normal, moderately impaired, or severely impaired — as measured by specific blood markers.
• People whose kidneys are functioning above a minimum level, calculated using age, weight, and a blood marker called creatinine.
• People who have not had major surgery in the 30 days before starting the study drug.
• People with a life expectancy of at least 3 months.
• Women who could become pregnant must not currently be pregnant or breastfeeding, must have a negative pregnancy test at the start of the study, and must agree to use at least one highly effective form of contraception and not become pregnant for at least 6 months after finishing treatment.
• Male participants with a female partner who could become pregnant must agree to use a condom and ensure their partner uses an effective form of contraception during treatment and for at least 3 months after finishing treatment.

Who may not be able to join:

• People who have received the cancer drugs azacitidine or decitabine within 4 weeks before screening, or who have previously received cytotoxic chemotherapy for AML (except a drug called hydroxyurea used to control high white blood cell counts).
• People who were hospitalised for more than 2 days in the 30 days before their first dose due to a serious infection, fever with low white blood cells, pneumonia, or blood infection.
• People who have received another experimental treatment, chemotherapy, immunotherapy, or targeted therapy within 2 weeks (or within the time it takes for 5 half-lives of that drug to pass, whichever is longer) before starting the study drug, or who still have significant ongoing side effects from a previous treatment.
• People currently receiving certain MDS treatments, including drugs such as lenalidomide, erythropoietin, or immune-suppressing medications — though prior use of these drugs is allowed if finished at least 1 week before the first study dose.
• People who have received a live (weakened) vaccine within 4 weeks before starting the study drug; other types of vaccines should not be given from 7 days before the first dose until after the follow-up visit.
• People with serious uncontrolled medical conditions, active uncontrolled infections, or other health problems that may make it unlikely they could complete even one cycle of treatment.
• People with certain heart rhythm concerns, including a specific heart electrical measurement (QTcF) above set limits at screening, a history of a dangerous heart rhythm condition called torsades de pointes, or who are currently taking other medications known to affect heart rhythm.
• People with unstable heart disease, severe heart failure (rated Class III or IV on a standard scale), uncontrolled high blood pressure (with repeated readings at or above 180/110 mmHg), or a documented history of significant low blood pressure episodes.
• People with a significant mental health condition, or active alcohol or substance addiction, that the study doctor believes would make it difficult to safely follow the study requirements.
• People with AML or MDS whose disease is rapidly worsening in a way that is likely to require intensive chemotherapy within the next 3 months.
• People with life-threatening illness or severe organ problems — such as uncontrolled heart failure or severe lung disease — or other factors that the study doctor believes could affect safety, how the body processes the study drug, or the ability to complete the study.
• People with untreated cancer that has spread to the brain or spinal cord; however, people whose brain or spinal cord involvement has been treated and has been stable for at least 4 weeks before screening may be eligible.
• People living with HIV.
• People who test positive for hepatitis C antibodies and also test positive on a specific viral activity test (RNA PCR); people who test positive for the antibody but negative on the RNA test may still be eligible.
• People who test positive for an active hepatitis B infection marker (HBsAg); certain people with other hepatitis B markers may still be eligible depending on specific test results (confirm with trial site).
• People whose average alcohol intake exceeds 24 units per week (for men) or 17 units per week (for women), where one unit equals approximately 250 mL of beer, 75 mL of wine, or 25 mL of spirits.
• People who have donated or lost more than 500 mL of blood in the 60 days before starting the study drug.
• People with a known allergy or sensitivity to decitabine, cedazuridine, or any ingredients in the study drug.

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