Phase 3 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 a confirmed diagnosis of a blood cancer called CLL (Chronic Lymphocytic Leukaemia) or SLL (Small Lymphocytic Lymphoma) that requires treatment, based on established 2018 medical guidelines
• For Part 1 of the trial: People whose cancer has been tested to determine whether a specific genetic change called "17p deletion" is present or absent. For Part 2: People whose cancer has been confirmed to have the 17p deletion through a specific genetic test called FISH
• People whose general health and ability to carry out daily activities falls within an acceptable range, as measured by a standard medical scoring system (scored 0 to 2 out of 4)
• People whose blood and organ function meet minimum levels, including: platelet counts, red blood cell levels (haemoglobin), white blood cell counts (neutrophils), and kidney function — with some flexibility in these levels for people whose bone marrow is directly affected by the cancer (confirm specific thresholds with trial site)

Who may not be able to join:

• People whose CLL/SLL has changed into a more aggressive form of cancer, such as diffuse large B-cell lymphoma, prolymphocytic leukaemia, or Hodgkin's lymphoma, at any point before joining the trial
• People where there is known or suspected cancer involvement in the brain or spinal cord
• People with a significant history of serious kidney, nerve, psychiatric, hormone, metabolic, or immune system disease
• People with active, uncontrolled immune conditions that are attacking their own blood cells, such as autoimmune haemolytic anaemia or immune thrombocytopenic purpura
• People with significant heart conditions, including a heart pumping function below 40%, or any ongoing irregular heart rhythm called atrial fibrillation or atrial flutter
• People whose screening blood tests show an active or ongoing Hepatitis B or Hepatitis C infection
• People with an active cytomegalovirus (CMV) infection
• People with an active, uncontrolled bacterial, viral, or fungal infection anywhere in the body
• People with a known HIV infection, regardless of immune cell levels
• People with a significant condition that affects how the gut absorbs medicines taken by mouth
• People with ongoing inflammatory bowel disease
• For Part 1: People who have previously been treated with a specific type of targeted drug called a BTK inhibitor (either covalent or noncovalent type). For Part 2: People who have received any prior treatment for CLL/SLL
• People currently receiving another experimental treatment or anti-cancer therapy (hormonal therapy is an exception — confirm with trial site)
• People who require ongoing blood-thinning treatment with warfarin or a similar medication called a Vitamin K antagonist
• People taking more than 20 mg of prednisone daily (or an equivalent steroid dose) at the time the study drug would first be given
• People who have received a live vaccine within 28 days before being enrolled in the trial
• People who are on ongoing treatment with certain strong medications that affect how the body processes drugs (called strong CYP3A inhibitors), unless that medication can be stopped within an appropriate timeframe before starting the study drug — note that posaconazole and voriconazole are exceptions (confirm with trial site)
• People with a known serious allergic reaction, including anaphylaxis, to any ingredient in the study drugs pirtobrutinib or ibrutinib

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