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 are willing to give written consent and follow all study procedures
• People aged 18 or older
• People who have been diagnosed with acute myeloid leukemia (AML), a type of blood cancer
• People whose AML has come back or stopped responding to treatment, and whose cancer has a specific genetic change called NPM1 mutation
• People for whom no standard treatment is available that is expected to help, or who are not eligible for standard treatment, or who have chosen not to receive it
• People who are well enough to carry out daily activities with little to no limitation (based on a standard medical fitness scale scored 0 to 2)
• People whose white blood cell count is at or below a certain level at the time of screening (a medication to lower white blood cells may be used to reach this level)
• People whose liver, kidneys, and other organs are functioning adequately according to the trial's requirements
• Women who could become pregnant must be willing to use a highly effective form of contraception throughout the trial and for at least 187 days after the last dose
• Men with female partners who could become pregnant must agree to use a highly effective form of contraception throughout the trial and for at least 97 days after the last dose

Who may not be able to join:

• People diagnosed with a specific subtype of blood cancer called acute promyelocytic leukemia
• People who have received a donor lymphocyte infusion within the 30 days before joining the trial
• People who currently have leukemia that has spread to or is active in the brain or spinal fluid
• People who have had a stem cell transplant from a donor and have not recovered adequate blood cell levels afterwards
• People with active moderate-to-severe graft-versus-host disease (a complication that can occur after a stem cell transplant)
• People who have previously been treated with a type of drug called a menin inhibitor
• People who have received chemotherapy, immunotherapy, radiation therapy, or another experimental treatment within 14 days or within a certain number of half-lives before starting the trial
• People who still have significant side effects (above a mild level) from previous treatments
• People who need to take certain medications that strongly affect the way the body breaks down drugs (called strong CYP3A4 inducers) (confirm with trial site)
• People with an active or uncontrolled infection, including hepatitis B, hepatitis C, or HIV
• People with conditions that make them highly vulnerable to serious infections or who have significant immune system problems
• People with heart disease or a specific abnormality in the heart's electrical activity detected on testing
• People with a lung condition called interstitial lung disease
• People who have had major surgery within 4 weeks before starting the trial
• Women who are pregnant or breastfeeding
• People with any medical, mental health, or personal circumstances that the trial doctor believes could affect their safety or ability to participate

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