Phase 2 Lymphoma 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 agreement to take part and are willing and able to follow all study requirements, including visits, treatments, and tests.
• People who have been diagnosed with a specific type of blood cancer called B-cell acute lymphoblastic leukemia or lymphoma (B-ALL/LBL), confirmed by laboratory testing, where the cancer cells carry certain markers called CD19 and/or CD22, and whose cancer went into first complete remission (fewer than 5% cancer cells in the bone marrow) after standard chemotherapy.
• People whose B-ALL is considered standard-risk (not high-risk), who have responded well to treatment, completed two rounds of intensive consolidation chemotherapy, have shown no detectable cancer remaining by two types of sensitive testing, are not considered to need a stem cell transplant, and for whom a specific antibody treatment (blinatumomab) is not suitable or has been declined — meaning CAR-T cell therapy is being planned as the next treatment step.
• 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 with limited restriction).
• People with an estimated life expectancy of at least 3 months.
• People whose blood counts meet minimum levels: haemoglobin of at least 60 g/L (blood transfusions are allowed to reach this), neutrophils (a type of infection-fighting blood cell) of at least 1,000 per microlitre, and platelets of at least 45,000 per microlitre.
• People whose liver, kidney, and heart function fall within acceptable ranges, including liver enzyme and bilirubin levels not too far above normal, kidney function above a certain threshold, heart pumping function of at least 50%, normal heart rhythm, no significant fluid around the heart or lungs, and blood oxygen levels above 92% while breathing normal air.
• People of reproductive potential who agree to use effective contraception from enrolment until at least 6 months after the study ends, and who agree to notify the study team immediately if pregnancy occurs or is suspected.

Who may not be able to join:

• People whose B-ALL has come back or has not responded to treatment, or who have features indicating a stem cell transplant is needed, and who are planned to receive a transplant or blinatumomab therapy and do not want CAR-T cell therapy — this includes people whose cancer came back within 6 months of first remission, whose cancer never responded to two rounds of standard chemotherapy, whose cancer did not respond to or came back after salvage chemotherapy, whose cancer came back after a stem cell transplant, or who have persistent detectable cancer with a high risk of relapse.
• People who have previously received CAR-T cell therapy or any other genetically modified T-cell treatment.
• People with a known history of HIV, active hepatitis B virus infection (as defined by specific blood test levels and liver enzyme results), 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 the upper limit of normal, bilirubin more than twice the upper limit of normal, or kidney function below a certain threshold.
• People who have had a significant heart event in the 12 months before joining, such as a heart attack, coronary artery procedure, unstable chest pain, or a clinically significant abnormal heart rhythm.
• People with other serious or poorly controlled health conditions that could interfere with the study, including uncontrolled diabetes, severe gut disease, severe heart or lung disease, autoimmune disease, immune system problems, or uncontrolled infections.
• People with a history of severe allergic reactions to any of the study-related medications, a class of antibiotics called aminoglycosides, or biological therapies.
• People who are pregnant or breastfeeding.
• People who are unable or unwilling to follow the study procedures or attend follow-up appointments, or who the study doctor believes are unlikely to adhere to the study requirements.
• People with a history of another cancer, unless they have been free of that cancer and off treatment for at least 3 years (certain skin cancers and non-spreading cancers treated locally may be exceptions — confirm with trial site).
• People who have received a live vaccine within 6 weeks before the start of the pre-treatment chemotherapy phase of the study.
• People who have had major surgery within 14 days before enrolment, or who have major surgery planned during the study.
• People who, in the study doctor's judgement, have any other condition that could increase risk, affect the study results, or make participation unsuitable.

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