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 who have signed a consent form before any study procedures begin
• Male and female patients who have been diagnosed with a type of blood cancer called B-cell acute lymphoblastic leukaemia (B-ALL) that has a specific marker called CD19 on the cancer cells
• Patients in Cohort A: those whose cancer cells have fewer than 45 chromosomes (a condition called hypodiploidy), regardless of how their cancer has responded to treatment
• Patients in Cohort B: those whose cancer cells have a specific chromosomal change called t(17;19), regardless of how their cancer has responded to treatment
• Patients in Cohort C: babies under 6 months old newly diagnosed with a specific type of B-ALL involving a gene change called KMT2A rearrangement, who meet at least one of these higher-risk features: diagnosed before 3 months of age; diagnosed before 6 months of age with a very high white blood cell count or a poor response to early treatment; or still showing signs of cancer after two rounds of standard infant treatment
• Patients in Cohort D: those experiencing their first or subsequent relapse of cancer in the central nervous system (brain and spinal cord), who have not yet received radiation to the head or a stem cell transplant for this current relapse
• Patients whose cancer cells showing the CD19 marker have been confirmed through bone marrow, blood, spinal fluid, or tissue testing
• People aged 0 to 29 years
• People whose kidneys are working well enough, based on blood test results appropriate for their age and sex (confirm with trial site)
• People whose liver is working well enough, based on specific blood test results, or where any abnormal liver results are caused by the leukaemia itself rather than other liver disease (confirm with trial site)
• People with adequate lung function, defined as minimal breathing difficulty and acceptable oxygen levels, and lung capacity testing results if clinically appropriate (confirm with trial site)
• People whose heart is pumping well enough, based on an echocardiogram (heart ultrasound) showing the heart is functioning within acceptable ranges
• People who are well enough to carry out at least some daily activities, as measured by a standard medical scoring scale
• People who are able to have children and agree to use acceptable contraception during the trial

Who may not be able to join:

• People in Cohort D (CNS relapse) who have already received radiation to the head or a bone marrow transplant for their current relapse
• People with an active hepatitis B or hepatitis C infection
• People living with HIV
• People currently experiencing graft-versus-host disease (a complication that can occur after a transplant) that requires ongoing systemic treatment
• People who are taking steroid medications throughout their whole body at the time the cells are collected or given back, or who are likely to need such steroids during those periods (note: steroids used at other times, or low-dose replacement steroids or inhaled steroids, may still be permitted — confirm with trial site)
• People whose cancer has spread to the brain tissue in a way that is getting worse despite treatment, or in a way that may increase the risk of serious nervous system side effects
• People who are pregnant or currently breastfeeding
• People with an active infection that is not under control

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