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:

• Children and young people aged 26 or younger at the time of signing consent forms who have been diagnosed with one of the blood cancers or bone marrow conditions listed below, and for whom no suitably matched donor (related or unrelated) has been found within 4 weeks (Cohort 1 – High Risk Disease)
• People with a type of blood cancer called AML (acute myeloid leukaemia) who are in their first full remission with fewer than 5% abnormal cells in the bone marrow, AND who have features that make relapse more likely — such as a prior bone marrow disorder, certain high-risk genetic changes, needing more than one round of treatment to reach remission, cancer that developed after previous cancer treatment or gene/cell therapy, or detectable traces of remaining disease
• People with AML who have reached a second or later remission with fewer than 5% abnormal cells in the bone marrow
• People with ALL (acute lymphoblastic leukaemia) in their first full remission with no detectable remaining disease, and who have features that make relapse more likely — such as certain high-risk genetic changes, not responding fully to initial treatment, or a type called T-ALL
• People with ALL who have reached a second or later full remission with no detectable remaining disease, particularly if relapse happened within 3 years of first remission or involved T-ALL
• People with ALL or AML whose disease responded to antibody-based treatments (such as blinatumomab or inotuzumab) or CAR-T cell therapy, resulting in no detectable remaining disease
• People with other types of acute leukaemia (including mixed or ambiguous types) with fewer than 5% abnormal cells in the bone marrow, or with very low levels of detectable abnormal cells
• People with a history of a type of leukaemia called CML (chronic myeloid leukaemia) that previously went through a severe (blast crisis) or accelerated phase
• People with any leukaemia that developed after gene therapy or cell therapy
• People with a bone marrow disorder called MDS (myelodysplastic syndrome) of any risk level that has caused serious blood count problems, or that involves certain high-risk genetic changes
• People with certain types of lymphoma (including aggressive and slower-growing types) who are in remission or have stable disease, meeting specific tumour size conditions depending on the lymphoma type
• People who have previously had a bone marrow transplant, whose disease came back, and who have since achieved remission again — with the second transplant occurring at least 4 months after the first (Cohort 2 – Very High Risk Disease)
• People with relapsed or treatment-resistant disease at either a first or second transplant, where abnormal cells make up less than 30% of bone marrow cells
• People who are not pregnant and not breastfeeding
• People whose organs are functioning well enough to meet all of the following: bilirubin blood level at or below 1.5 mg/dL (unless due to a harmless inherited condition); liver enzyme (ALT) level no more than 3 times the upper limit of normal; lung function tests at 50% or more of expected levels (or, for young children who cannot do these tests, blood oxygen above 92% in room air and a normal chest scan); heart pumping function above 50%; a transplant-specific health score (aaHCT-CI) of 7 or lower; and kidney function within acceptable ranges for age
• Female patients who could become pregnant must have a negative pregnancy blood test within 7 days of joining, and must be willing to use effective contraception during the study
• People with a history of hepatitis B who have an undetectable virus level while on appropriate treatment (confirm with trial site)
• People with a history of hepatitis C who have completed treatment and been cured, or who are currently on treatment with an undetectable virus level (confirm with trial site)
• People whose prior use of checkpoint inhibitor medications (a type of immune therapy) in the last 12 months will be assessed individually with the lead study doctor (confirm with trial site)

Who may not be able to join:

• People whose physical performance or organ function does not meet the required levels
• People with leukaemia that has spread to the central nervous system (brain and spinal fluid), or who have a tumour mass larger than 2 cm in that area
• People with an active infection (bacterial, fungal, or viral) that is not under control at the time of the transplant
• People living with HIV
• People who test positive for a virus called HTLV-1
• People who are pregnant or breastfeeding
• People (or their parent or guardian) who are unable to give informed consent, or who are unable to follow the treatment plan, attend follow-up appointments, or take part in research testing
• People with any other abnormal medical condition or test result that the lead study doctor believes could affect the person's health or the study results
• People in Cohort 2 (Very High Risk) who have had a bone marrow transplant within the past 4 months

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