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 aged 12 years or older who weigh at least 40 kg (approximately 88 pounds)
• People who are reasonably functional in daily life (as assessed by a standard medical scale called the ECOG score of 2 or below — confirm with trial site)
• People who have been newly diagnosed with AML or a related blood cancer (called myeloid phenotype MPAL) with a specific genetic change (KMT2A, NUP98, or NPM1 mutation), and who are not suitable for intensive chemotherapy — or people whose cancer has returned or stopped responding to treatment
• People whose white blood cell count is below 25,000 per microlitre at the time of joining (a doctor may be able to give treatment beforehand to bring this number down)
• People whose heart pumping function (ejection fraction) is above 40%
• People whose liver is functioning adequately, based on specific blood test results (confirm with trial site)
• People whose kidneys are functioning adequately, based on a measure called creatinine clearance of at least 30 mL/min, unless the kidneys are affected by the disease itself
• People who are willing and able to give informed consent to participate
• People who have waited the required time since their last treatment before starting the trial (at least 14 days, or 5 half-lives of the prior treatment, depending on the situation — confirm with trial site)
• Women who could become pregnant must agree to use adequate contraception during the study and for at least 3 months after the last treatment; men must either be sterile or agree to use adequate contraception for the same period

Who may not be able to join:

• People who have previously been treated with a type of drug called a menin inhibitor
• People who have another serious uncontrolled medical condition, significant abnormal lab results, or a mental health condition that could put them at unacceptable risk during the trial
• People who have a severe stomach or digestive condition that could prevent the oral study medication from being properly absorbed
• People who are currently being treated for another active cancer
• People with a known active hepatitis B, hepatitis C, or HIV infection
• Women who are pregnant or breastfeeding
• People who have an active, uncontrolled infection
• People who, within the past 6 months, have had a heart attack, unstable chest pain (angina), significant heart failure, a life-threatening irregular heartbeat, a stroke, or a mini-stroke (transient ischaemic attack)
• People with a specific type of abnormal heart electrical reading (QTc above 470 milliseconds using the Fridericia Formula — confirm with trial site)
• People with a history of certain heart electrical conduction problems, such as a complete bundle branch block or a high-degree heart block
• People with actively spreading leukaemia in the brain or spinal fluid (clinically active CNS leukaemia)
• People who have received a stem cell transplant and are still taking immune-suppressing medications at the time of screening, unless they have been off all such medications for at least 2 weeks (or at least 4 weeks for a specific type called calcineurin inhibitors)
• People with significant graft-versus-host disease (GVHD) above a certain severity level following a stem cell transplant (confirm grading details with trial site)
• People whose situation, in the investigator's judgement, could interfere with the study results or would not be in their best interest to participate

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