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 who have given written consent and are willing and able to follow the study schedule, including visits, treatments, and tests.
• People who have been confirmed by laboratory testing (cell or tissue samples) to have a type of blood cancer called B-cell acute lymphoblastic leukemia or lymphoma (B-ALL/LBL), where the cancer cells carry markers called CD19 and/or CD22, and who have reached a first complete remission (meaning less than 5% cancer cells in the bone marrow) after standard initial chemotherapy.
• People whose disease is considered high-risk — either because of certain genetic features of the cancer regardless of remaining cancer levels, or because low-level cancer (MRD) is still detectable after two rounds of consolidation chemotherapy — and who are not able or not willing to have a bone marrow transplant from a donor, and whose doctors plan to use CAR-T cell therapy as a follow-up treatment.
• People aged 18 to 85 years, of any sex.
• People with a general health and activity level rated 0, 1, or 2 on a standard medical scale (meaning able to carry out at least some daily activities, confirm with trial site).
• People with an estimated life expectancy of at least 3 months.
• People whose haemoglobin (a measure of red blood cells) is at least 60 g/L — blood transfusions to reach this level are permitted.
• People whose neutrophil count (a type of infection-fighting white blood cell) is at least 1,000 per microlitre, and whose platelet count is at least 45,000 per microlitre.
• People whose liver, kidney, and heart function fall within acceptable ranges, specifically: liver enzyme and bilirubin levels not significantly above normal; kidney function showing adequate clearance; heart pumping function of at least 50% with no serious rhythm problems or fluid around the heart; and blood oxygen levels above 92% breathing normal air, with no significant fluid around the lungs.
• People who are capable of having children and who agree to use effective contraception from enrolment until at least 6 months after the study ends; people who are or may be pregnant must inform the study team immediately.

Who may not be able to join:

• People whose B-ALL has come back or has not responded to treatment — including those whose cancer returned within 6 months of first remission, those who never reached remission after two rounds of standard chemotherapy, those who did not respond to or relapsed after salvage chemotherapy, or those who relapsed after a prior donor bone marrow transplant — and who are planned to receive a donor bone marrow transplant or a drug called blinatumomab instead of CAR-T cell therapy.
• People who have previously received CAR-T cell therapy or any other treatment involving genetically modified T-cells.
• People with a known history of HIV infection, active hepatitis B virus infection (as defined by specific blood test results, confirm with trial site), or any uncontrolled active infection currently requiring intravenous antibiotics.
• People with liver or kidney problems not caused by their cancer, specifically: liver enzyme levels more than 3 times above normal, bilirubin more than twice the upper normal limit, or significantly reduced kidney function.
• People who have had a serious heart event in the 12 months before enrolment, such as a heart attack, a procedure to open blocked heart arteries, unstable chest pain, or a significant heart rhythm problem.
• People with other serious or poorly controlled health conditions that could affect participation, including uncontrolled diabetes, severe gut disease, severe heart or lung disease, autoimmune conditions, immune deficiency, or uncontrolled infections.
• People with a history of severe allergic reactions to any of the study drugs, a class of antibiotics called aminoglycosides, or biological medicines.
• People who are pregnant or breastfeeding.
• People who are unable or unwilling to follow study procedures or attend follow-up appointments, or whom the investigator considers unlikely to comply.
• People with a history of another cancer, unless they have been free of that cancer and off treatment for at least 3 years (exceptions may apply for certain skin cancers or very early-stage cancers, confirm with trial site).
• People who received a live vaccine within 6 weeks before the start of the preparatory chemotherapy given before CAR-T cell treatment.
• People who have had major surgery within 14 days before enrolment, or who have major surgery planned during the study period.
• People who, in the investigator's judgement, have any other condition that could increase risk, interfere with results, or make participation unsuitable.

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