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) or SLL (small lymphocytic lymphoma), confirmed using standard medical guidelines.
• People whose cancer has come back after at least one previous treatment, and who currently need further treatment based on established medical criteria.
• For Group A (Cohort A): People who have never been treated with a type of drug called a covalent BTK inhibitor (such as ibrutinib or acalabrutinib) or a BCL-2 inhibitor.
• For Group B (Cohort B): People who have previously been treated with either a BTK inhibitor or a BCL-2 inhibitor, but not both, and whose cancer did not progress while on that treatment.
• For Group C (Cohort C): People whose cancer got worse while they were being treated with a covalent BTK inhibitor (not including zanubrutinib).
• People aged 18 or older.
• People who are well enough to carry out daily activities to at least a moderate degree, as measured by a standard medical scale (confirm with trial site).
• People whose blood counts, liver function, and kidney function meet certain minimum levels as determined by blood tests (confirm with trial site).
• People who are able and willing to use reliable contraception (such as hormonal or barrier methods, or abstinence) throughout the trial and for a period after it ends, as the effects of the trial drugs on an unborn baby are not known. Men enrolled in the trial must also agree to use contraception for at least 4 months after finishing the trial drugs.
• People who are able to understand the study and are willing to sign a written consent form.
• People who are able to swallow and keep down oral medication (tablets or capsules).

Who may not be able to join:

• People who have a specific genetic mutation called BTK C481X.
• For Group B (Cohort B): People who have previously been treated with both a BTK inhibitor and a BCL-2 inhibitor.
• People who have received any anti-cancer treatment (such as chemotherapy, radiation, immunotherapy, or surgery) within 2 weeks before the trial starts, with some specific exceptions such as low-dose steroid therapy or certain hormonal treatments (confirm with trial site for details).
• People who have previously had a bone marrow or stem cell transplant from another person (allogeneic transplant).
• People whose cancer has spread to the central nervous system (brain or spinal cord).
• People who are currently taking part in another clinical trial involving an experimental treatment.
• People who have had another type of cancer in the past, with some exceptions such as cancers treated successfully with no signs of return for at least 2 years, certain treated skin cancers, treated pre-cancerous conditions, or low-risk prostate cancer being monitored (confirm with trial site).
• People who have received a live vaccine within 4 weeks before the trial starts.
• People who have recently had a serious infection requiring treatment with intravenous antibiotics, completed within 7 days before the trial starts, or who currently have an uncontrolled active infection.
• People who have a known bleeding disorder such as von Willebrand's disease or haemophilia.
• People who have had a stroke, bleeding in the brain, or a major bleed within the past 6 months.
• People who need to take warfarin or similar blood-thinning medications (certain other blood thinners may be allowed with approval from the lead investigator).
• People who need to take certain medications that are known to strongly or moderately interfere with how the trial drugs are processed by the body (confirm with trial site, as this list can change).
• People with a known history of HIV, or active hepatitis B or hepatitis C infection.
• People who have had a serious allergic reaction to medications that are chemically similar to the trial drugs zanubrutinib or venetoclax.
• People with a mental health condition or personal circumstances that would make it difficult to follow the trial requirements.
• People who are pregnant or breastfeeding, as the trial drugs may be harmful to an unborn baby or infant.
• People who have significant problems absorbing food or medication through their digestive system, including certain bowel conditions or previous stomach or bowel surgery.
• People with serious or uncontrolled heart conditions, or who have had a heart attack, unstable chest pain, or acute coronary event within the past 6 months.
• People with any other serious illness or medical condition that the treating doctor believes could put the person at risk or affect the reliability of the trial results.
• People with certain active autoimmune conditions affecting their red blood cells or platelets.

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