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:

• People aged 14 to 65 years (inclusive), of any gender
• People who have been newly diagnosed with a type of blood cancer called B-cell acute lymphoblastic leukaemia (B-ALL) where the cancer cells carry a protein called CD19 (at any level of expression)
• People with a specific high-risk form of B-ALL (Ph-negative) who have already received a bone marrow/stem cell transplant from a donor and have high-risk features
• People who are at least 2 months past their stem cell transplant and whose blood cell production has recovered
• People whose bone marrow shows no signs of active leukaemia and whose sensitive disease testing (MRD) is negative before joining
• People who are in reasonably good general health, as measured by standard medical scoring tools (ECOG score below 3 and Karnofsky score of 70 or above)
• People with no history of severe graft-versus-host disease (a complication of transplants) and no active graft-versus-host disease at the time of joining
• People whose liver, kidney, and heart are functioning adequately — specifically, liver enzyme and bilirubin levels within acceptable ranges, kidney function meeting set thresholds, and heart pumping function (LVEF) of 50% or above on an ultrasound scan
• People whose life expectancy is more than 3 months
• People who are willing and able to give written informed consent and follow the study requirements

Who may not be able to join:

• People who have had a serious allergic reaction or severe side effects to the study drug or similar medicines, where the medical team considers this a safety concern
• People who are pregnant or breastfeeding, or people of childbearing potential who are unwilling to use effective contraception during the study
• People with serious heart problems, including heart pumping function (EF) below 60%, significant irregular heartbeats, a prolonged electrical interval on a heart trace (QTc over 450ms for men or over 470ms for women), a heart attack within the past year, or active coronary artery disease requiring medication
• People with severe lung problems affecting their ability to breathe properly
• People with severe liver impairment, specifically liver enzyme (ALT) or bilirubin levels above 3 times the normal upper limit
• People with severe kidney impairment, where creatinine levels are more than twice the normal upper limit or kidney filtration rate is below 50 mL/min
• People with an active infection or uncontrolled bleeding that the medical team considers a safety concern
• People who have had a blood clot, stroke, brain bleed, or other serious blood vessel event within the past year
• People with a psychiatric condition or other issue that affects their ability to consent or follow the study procedures
• People who have had major surgery within the past six weeks
• People with a history of drug abuse or chronic heavy alcohol use that may affect how the study is assessed
• People who have previously had a solid organ transplant (a prior stem cell transplant is not an exclusion)
• People considered unsuitable by the medical team for any other reason

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