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 been diagnosed with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) that has transformed into a specific type of aggressive lymphoma called diffuse large B-cell lymphoma (DLBCL), confirmed by a biopsy
• People who are 18 years of age or older
• People who are able to understand and sign a consent form agreeing to take part
• People who are willing and able to follow all the study procedures
• People who are expected to live for at least 24 weeks
• People whose general health and ability to carry out daily activities meets a certain minimum level, as assessed by a standard medical scale (confirm with trial site)
• People who have at least one measurable area of disease, with a lymph node measuring at least 1.5 cm at its longest point
• People whose bone marrow is producing enough blood cells, meeting minimum levels for white blood cells, red blood cells, and platelets — with the note that blood transfusions or growth factor support are permitted at least 7 days before joining the trial
• People whose liver, kidneys, and heart are functioning adequately, meeting specific minimum thresholds set by the trial (confirm with trial site for exact values)
• People with a liver condition called Gilbert's disease may still be eligible despite one liver-related threshold, as an exception applies
• Women who could become pregnant must agree to use highly effective contraception (less than 1% failure rate per year) or remain abstinent during treatment and for at least 12 months after the last dose, and must have a negative pregnancy test within 7 days before starting the trial
• Men must agree to use a condom plus an additional contraceptive method, and to avoid donating sperm, during treatment and for at least 5 months after the last dose — men interested in preserving fertility should consider sperm banking before the trial begins

Who may not be able to join:

• People whose disease has transformed into a type of lymphoma other than DLBCL (for example, Hodgkin lymphoma)
• People who have already received treatment specifically targeting the transformed (DLBCL) part of their disease
• People who start a new targeted therapy (such as BTK inhibitors, venetoclax, or PI3K inhibitors) before enrolling — though continuing an existing CLL-directed targeted therapy as a temporary bridge during screening may be permitted, up to 72 hours before the trial starts (confirm with trial site)
• People who have had a donor stem cell transplant for CLL within the past 6 months
• People who have another active cancer at the time of enrolment — though people whose previous cancer was treated with the aim of a cure and who have had no signs of it returning for at least 3 years may still be eligible; certain skin cancers and cervical cancers that have been surgically removed are also exceptions
• People who are known to be HIV-positive
• People with active hepatitis B or hepatitis C, confirmed by specific blood tests — though people with a past hepatitis B exposure (positive core antibody but no detectable virus) may be eligible with close monitoring
• People who already have nerve damage (peripheral neuropathy) rated at a moderate level or above
• People with a history of severe or life-threatening allergic reactions to certain types of antibody-based medicines
• People with signs that the transformed lymphoma has spread to the brain or spinal cord
• People with other serious, uncontrolled medical conditions that could affect their safety or the trial results
• People with significant heart problems, such as severe heart failure, a heart attack in the past 6 months, or unstable heart rhythms or chest pain
• People with a known active infection at the time of enrolment, or who have needed hospital treatment or intravenous antibiotics for an infection within the past 4 weeks
• People who have had major surgery within 4 weeks before the trial starts — note that certain lymph node biopsies are also considered exclusionary under this rule (confirm with trial site)

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