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:

• Children and young people aged 2 to 21 years old
• People whose ability to carry out daily activities is not severely limited (based on a standard medical scale called ECOG, with a score of 2 or lower)
• People who have been diagnosed with a relapsed (came back) or treatment-resistant (refractory) form of acute leukaemia — specifically AML, mixed phenotype acute leukaemia, ALL, or acute leukaemia of ambiguous lineage — and whose leukaemia has a specific genetic change in one of these genes or pathways: KMT2A, NPM1, NUP98, or HOX
• People whose bone marrow shows at least 5% leukaemia cells at the time of joining
• People whose white blood cell count is below a certain level (25 K/µL) at the time of enrolment — doctors may reduce this count beforehand if needed
• People whose heart is pumping with at least 40% efficiency (measured by a test called ejection fraction)
• People whose liver is working well enough, based on blood test results (with some exceptions allowed if the liver readings are affected by the leukaemia itself)
• People whose kidneys are working at a sufficient level, unless any reduction in kidney function is caused by the disease (confirm with trial site)
• People who have waited at least 14 days — or a period based on how long their previous treatment stays in the body — since their last cancer treatment, unless the disease is growing very rapidly (some limited treatments may still be allowed during this period — confirm with trial site)
• People who are able to use reliable contraception during the study and for at least 3 months (for males) or 6 months (for females) after the last treatment, unless they are unable to have children for surgical or biological reasons

Who may not be able to join:

• People who weigh less than 10 kilograms
• People who have another serious uncontrolled medical condition, abnormal lab results, or mental health condition that could make participation unsafe
• People who are currently taking other chemotherapy or anti-leukaemia treatments, with limited exceptions such as certain treatments given directly into the spinal fluid, low-dose steroid use, or hydroxyurea for rapidly growing disease
• People with a severe stomach or digestive condition that could stop oral medications from being properly absorbed
• People who are currently being treated for another active cancer
• People with an active hepatitis B or hepatitis C infection, or an active or uncontrolled HIV infection, or who are taking HIV medications that cannot be safely combined with this trial's treatments
• People who are pregnant or currently breastfeeding
• People who have an active, uncontrolled infection
• People who have had a heart attack, unstable chest pain, heart failure, a dangerous heart rhythm problem, a stroke, or a mini-stroke within the 6 months before joining the trial
• People whose heart's electrical activity (measured by an ECG) shows a reading above a certain level (corrected QT interval greater than 480 ms)
• People whose overall medical history, current condition, or test results could affect the trial results or make participation unsafe, in the opinion of the trial investigator
• People who currently have active leukaemia affecting the brain or spinal fluid
• People with moderate to severe active graft-versus-host disease (GVHD — a condition that can occur after a stem cell transplant), or extensive chronic GVHD of any severity (some mild or stable GVHD with low-dose steroid treatment may still be permitted — confirm with trial site)
• People who have eaten grapefruit, grapefruit products, Seville oranges (including marmalade made with Seville oranges), or star fruit within 3 days before the first dose of one of the trial medications (venetoclax)

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