Early Phase 1 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 are willing to sign a consent form and agree to follow the study requirements
• People aged 18 years or older, of any gender
• People who have been diagnosed with acute myeloid leukaemia (AML) using a specific combination of blood and cell tests, according to a recognised 2016 classification system
• People with AML who have received a stem cell transplant from a donor (called an allogeneic stem cell transplant)
• People whose AML is classified as "favourable-to-intermediate risk" according to a recognised 2022 set of guidelines used by leukaemia specialists
• People whose leukaemia shows signs of remaining disease at a very low level (called "measurable residual disease" or MRD), detected by specific laboratory tests
• People who are reasonably well and able to carry out daily activities, as measured by a standard health scoring system (score of 0–2 out of 5)
• People whose graft-versus-host disease (a condition where donated cells react against the body) is currently not active
• People whose blood counts meet a minimum level, meaning their immune cells and platelets are above certain thresholds
• People whose heart, liver, kidneys, and other organs are functioning adequately as set out in the study requirements
• People of reproductive potential who agree to use contraception throughout the study and for at least 28 days after it ends

Who may not be able to join:

• People whose AML has returned after the transplant, shown by a high number of leukaemia cells in the blood or bone marrow, or leukaemia spreading to other parts of the body
• People who have had active graft-versus-host disease within the 30 days before screening
• People with active infections including hepatitis B, hepatitis C, HIV, syphilis, or active CMV or EBV infections
• People with active inflammatory or autoimmune conditions affecting the nervous system, or significant active disease affecting blood flow to the brain
• People with certain unstable or serious health conditions, including recent heart attack or stroke (within 6 months), severe heart failure, difficult-to-control high blood pressure, significant heart rhythm problems, or severe liver, kidney, or metabolic disorders
• People who have had major surgery within 4 weeks before screening, where the trial doctor considers this to be a concern
• People who currently have a non-blood-related cancer
• People with certain heart problems, including reduced heart pumping function, severe heart failure, a prolonged electrical signal in the heart (QTc interval above a set level), or other heart conditions the trial doctor considers unsuitable
• People with a history of epilepsy or other active conditions affecting the brain or central nervous system
• People with serious ongoing infections that require active treatment, such as sepsis or tuberculosis
• People who have taken part in another interventional clinical trial within 30 days before enrolling
• People with any other circumstances that the trial doctor considers could affect their safety or the reliability of the study results

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