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 voluntarily agreed to take part, signed a consent form, and are willing and able to attend all required visits, tests, and procedures as set out in the trial plan
• People who have been diagnosed with a type of B-cell blood cancer (lymphoma or leukemia) that has come back or stopped responding to treatment, confirmed through laboratory and medical assessment methods, and who have either tried standard treatments without success, cannot tolerate standard treatments, or have no effective standard treatment options remaining
• People diagnosed with one of the following specific B-cell cancers that has returned or stopped responding to treatment: B-cell acute lymphoblastic leukemia (B-ALL); slower-growing B-cell lymphomas such as chronic lymphocytic leukemia, follicular lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma, or hairy cell leukemia; or faster-growing B-cell lymphomas such as diffuse large B-cell lymphoma, Burkitt lymphoma, or mantle cell lymphoma
• People with relapsed or treatment-resistant B-ALL who meet at least one of these: the cancer came back within 6 months of first achieving complete remission; the cancer never went into complete remission after 2 rounds of standard chemotherapy; the cancer did not respond to or came back after further chemotherapy attempts; or the cancer came back after a stem cell transplant
• People with relapsed or treatment-resistant B-cell lymphoma who meet at least one of the first four conditions (tumour shrank less than 50% or got worse after 4 rounds of standard chemotherapy; cancer came back within 6 months of complete remission; cancer has relapsed 2 or more times after remission; or cancer came back after a stem cell transplant), and who have also previously received treatment that included both an anti-CD20 antibody medicine and a chemotherapy combination containing a drug type called an anthracycline
• People aged 18 to 85 years (inclusive), of any sex
• People whose general physical condition is rated 0, 1, or 2 on a standard medical scale that measures how much a health condition affects daily activities (confirm with trial site)
• People whose life expectancy is more than 14 days from the time they sign the consent form
• People whose blood haemoglobin level is at or above 60 g/L (blood transfusions to reach this level are permitted)
• People whose blood counts for infection-fighting cells (neutrophils) are at or above 1,000 per microlitre and whose platelet count is at or above 45,000 per microlitre (transfusions to reach these levels are permitted)
• People whose liver, kidney, heart, and lung function results fall within the ranges required by the trial, including specific blood test results for liver and kidney markers, a heart pumping function of at least 50%, no serious fluid around the heart or serious irregular heartbeat, blood oxygen levels above 90% while breathing normal air, and no serious fluid around the lungs
• People who plan to become pregnant or father a child must agree to use contraception from before joining the trial until 6 months after the trial ends

Who may not be able to join:

• People who have previously received any type of CAR-T cell therapy or other genetically modified T-cell treatment
• People with a history of severe immediate allergic reactions to commonly used drugs such as aminoglycoside antibiotics
• People with a known HIV infection, active hepatitis B infection (as defined by specific test results and liver markers), or any uncontrolled active infection in the body that requires antibiotic treatment through a drip (note: people who had active hepatitis B but successfully converted to an inactive state with ongoing anti-hepatitis B treatment may still be considered — confirm with trial site)
• People with liver or kidney problems unrelated to their blood cancer, where certain liver or kidney test results fall outside the ranges the trial requires
• People who have had a heart attack, heart procedure, coronary stent, unstable chest pain, active irregular heartbeat, or other significant heart conditions within the 12 months before joining
• People with other serious health conditions that could affect the trial, such as poorly controlled diabetes, stomach ulcers, serious heart or lung disease, uncontrolled severe infections, serious autoimmune conditions, or inherited immune system disorders; this also includes people who received an allogeneic (donor) stem cell transplant and still have active graft-versus-host disease one month after stopping immune-suppressing medication (the trial doctor makes this judgement)
• People with a history of severe allergic reactions to any medicines specifically required in this trial, or severe allergic reactions to biological products including antibiotics
• People who are pregnant or currently breastfeeding
• People whom the trial doctor judges to be unable or unwilling to complete all required visits, tests, and procedures, including longer-term follow-up, or whose level of cooperation is considered insufficient (the trial doctor makes this judgement)
• People who currently have another active cancer of a different type, or who have a history of another cancer — except for certain non-melanoma skin cancers or early-stage cancers in places such as the cervix, bladder, or breast; people with a history of another cancer may be considered if they have been cancer-free and have not received any cancer treatment for at least 3 consecutive years
• People who have received a live vaccine within 6 weeks before the start of the pre-treatment conditioning phase
• People who have had major surgery (other than a lymph node biopsy) within the 14 days before joining, or who are expected to need major surgery during the treatment period
• People with other serious physical or mental health conditions, or significant abnormal laboratory results, that could increase risks or affect the trial results, or whom the trial doctor considers unsuitable for any other reason

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