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 a type of blood cancer called CLL (chronic lymphocytic leukemia) and whose cancer has specific high-risk genetic features — including a missing piece of chromosome 17 (del(17p)), a faulty TP53 gene, or a complex pattern of chromosome abnormalities — confirmed by laboratory testing (confirm with trial site for details on how prior test results may be used)
• People who have been taking ibrutinib or acalabrutinib for at least 12 months and still have measurable signs of CLL, such as high levels of abnormal white blood cells, enlarged lymph nodes larger than 1.5 cm on a CT scan, a high proportion of CLL cells in the bone marrow, or detectable CLL cells on a specialised blood test
• Adults aged 18 years or older
• People whose general physical health and ability to carry out daily activities meets a standard medical rating of 2 or below on a scale from 0 to 4 (where 0 is fully active and 4 is completely disabled)
• People whose kidneys and liver are functioning well enough to meet specific blood test thresholds (confirm with trial site for exact values)
• People whose bone marrow is producing enough blood cells — including platelets above a certain level without recent transfusions, sufficient white blood cells, and a haemoglobin level of at least 8mg/dL
• People whose blood clotting level (INR) is below 1.5
• People whose heart is functioning adequately, including no uncontrolled irregular heartbeat, a heart pumping function of at least 35% on an echocardiogram, and heart-related physical limitations rated at a mild level or better
• People who are able to give informed consent and attend required follow-up visits
• Women who could become pregnant must have a negative pregnancy test within 7 days before starting the study drugs, and must agree to use two forms of contraception (one highly effective method and one barrier method) during the study and for 30 days after the last dose; women who are post-menopausal or have had certain surgical procedures may be considered not at risk of pregnancy (confirm with trial site)
• Men with partners who could become pregnant must agree to use effective contraception during the study and for 30 days after the last dose
• People (or their legal representative) who are able to provide written informed consent

Who may not be able to join:

• People whose CLL has transformed into a more aggressive type of lymphoma called Richter transformation
• People who have another active cancer currently requiring systemic treatment, with some exceptions for certain previously treated skin cancers or other cancers that were fully treated with the intent to cure (confirm with trial site)
• People who have had major surgery, radiation, chemotherapy, immunotherapy, or other experimental treatments within the 3 weeks before starting the study drug
• People who have had a serious bleeding episode (grade 3 or 4) within the past 3 weeks
• People who have an active, uncontrolled infection (viral, bacterial, or fungal)
• People who are pregnant or breastfeeding
• People who have tested positive for HIV
• People with active hepatitis B infection, defined by the presence of certain detectable markers in the blood (some people with hepatitis B markers but no active infection may still be considered — confirm with trial site)
• People with active hepatitis C, confirmed by a specific blood test detecting hepatitis C genetic material
• People with an active, uncontrolled autoimmune condition — such as immune-related anaemia or low platelet count — that requires a daily steroid dose above a certain level within 7 days of starting the study drug
• People who have received another experimental treatment for CLL within 21 days of starting the study drug
• People currently taking the blood-thinning medication warfarin
• People who have taken certain medications that strongly affect how the body processes drugs (known as strong CYP3A inhibitors or inducers) within 7 days of starting the study drug (confirm with trial site for a list of affected medications)
• People who have eaten grapefruit, grapefruit products, Seville oranges, or star fruit within 7 days of starting the study drug
• People who have previously been treated with venetoclax or any other drug in the same class (Bcl-2 inhibitors)
• People who have a condition that prevents them from swallowing or absorbing oral medication properly

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