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 aged 18 or older
• People whose general health and ability to carry out daily activities meets a certain level of functioning (a score of less than 2 on a standard medical scale called the ECOG scale)
• People who have a type of blood cancer called AML or myeloid mixed-phenotype acute leukemia (MPAL) that has come back or stopped responding to treatment, and whose cancer has one of these specific genetic changes: NPM1 mutation, KMT2A rearrangement, or NUP98 rearrangement
• People whose white blood cell count is below a certain level (25,000/µL) at the time of joining — treatment to reduce this count beforehand may be permitted
• People whose heart is pumping at least 40% of its capacity (confirmed by a heart scan)
• People whose liver is functioning adequately, based on specific blood test results (confirm details with trial site)
• People whose kidneys are functioning at a sufficient level, based on a standard calculation — unless any reduced function is related to the disease itself
• People who are able to swallow tablets or capsules
• People (or their parent or guardian) who are willing and able to give informed consent to take part
• People who have waited a sufficient amount of time since their last cancer treatment before starting this trial — generally at least 14 days or five half-lives of the prior treatment, whichever is longer (exceptions may apply for rapidly progressing disease; confirm with trial site)
• Women who could become pregnant, and men who could father a child, who agree to use reliable contraception during the trial and for a set period after the last treatment (7 months for women, 4 months for men)

Who may not be able to join:

• People who have previously been treated with a type of drug called a menin inhibitor
• People with severe digestive or metabolic conditions that could affect how the body absorbs oral medications
• 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 currently pregnant or breastfeeding
• People who have an active infection that is not under control
• People who have experienced certain serious heart events in the 6 months before joining, including heart attack, unstable chest pain, significant heart failure, dangerous heart rhythm problems, stroke, or a mini-stroke
• People with a history of a consistently slow heart rate (below 50 beats per minute), unless a pacemaker is in place
• People who have been diagnosed with, or are suspected of having, a condition called congenital long QT syndrome, including those with a family history of this condition
• People with uncontrolled high blood pressure that remains very elevated despite medical treatment
• People whose heart's electrical activity shows a specific abnormality on an ECG (a QTc interval above 450 milliseconds using a standard formula)
• People whose overall medical situation, other conditions, treatments, or test results mean that the trial investigators believe participation would not be appropriate or safe
• People with active leukemia affecting the brain or spinal fluid
• People who have significant complications from a previous bone marrow transplant, specifically moderate-to-severe graft-versus-host disease (GVHD) (confirm details with trial site)

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