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:

• Adults aged 18 or older of any gender
• People whose general health and ability to carry out daily activities meets a certain minimum standard, and whose condition has been stable for at least 2 weeks before starting the trial
• People diagnosed with a specific type of chronic lymphocytic leukaemia (CLL) that tests positive for a protein called CD20, confirmed through specific blood markers
• People whose CLL is considered active and requires treatment, based on at least one of the following: low red blood cell or platelet counts caused by the disease; a very enlarged spleen; very enlarged lymph nodes; rapidly increasing white blood cell counts; anaemia or low platelets caused by the immune system attacking itself that has not responded well to steroid treatment; or significant symptoms such as unintentional weight loss of 10% or more in 6 months, severe fatigue, unexplained fevers lasting 2 or more weeks, or night sweats lasting more than 1 month without signs of infection
• People whose blood test results fall within acceptable ranges for white blood cells, platelets, liver function, and kidney function as measured before joining (specific thresholds apply — confirm with trial site)
• Women who are able to become pregnant and are sexually active must be willing to use highly effective contraception during the trial and for a specified period after the last dose of trial medication
• Men who are sexually active must be willing to use highly effective contraception plus a barrier method (condom) during the trial and for 90 days after the last dose of one of the trial medications
• Men must be willing to avoid donating sperm during the trial and for 90 days after the last dose of one of the trial medications
• People who are willing and able to take part in all required visits and tests, including being able to swallow capsules and tablets
• People who understand the purpose and risks of the trial and are able to provide written informed consent

Who may not be able to join:

• People with serious or uncontrolled health conditions (such as uncontrolled high blood pressure or a history of kidney transplant) that the trial doctor considers would make participation unsafe or difficult
• People who have previously received any systemic (whole-body) treatment for CLL (prior localised radiotherapy to a specific area is allowed)
• People with lymphoma or leukaemia that has spread to the brain or spinal cord
• People with a related blood cancer called prolymphocytic leukaemia, or who have or are suspected of having a condition called Richter's syndrome
• People with uncontrolled autoimmune destruction of red blood cells or platelets, including those requiring high doses of steroids (more than 20 mg of prednisone daily or equivalent) to manage this condition
• People who have been taking steroid medications at doses above 20 mg of prednisone (or equivalent) within 1 week before the first dose of trial medication, with some exceptions such as inhaled steroids for asthma or topical (skin) steroids
• People who have had major surgery within 30 days before the first dose of trial medication, unless they have fully recovered
• People with a history of another cancer, unless it was a skin cancer or cervical/prostate pre-cancer that was fully treated, or another cancer that was fully treated and has been in remission for 3 or more years without further treatment
• People with significant heart problems, such as heart failure, a heart attack within the past 6 months, or serious heart rhythm problems (people with well-controlled, symptom-free atrial fibrillation may still be considered — confirm with trial site)
• People with a history of or ongoing diagnosis of a serious brain condition called progressive multifocal leukoencephalopathy (PML)
• People who have taken another experimental drug within 30 days (or within 5 half-lives of that drug, whichever is shorter) before starting the trial
• People who have difficulty swallowing, severe nausea or vomiting, poor absorption of medications, or who have had certain bowel surgeries or conditions that could affect how the body processes the trial medication
• People who have received a live virus vaccine within 28 days before the first dose of trial medication
• People with a known history of HIV infection
• People with any active significant infection, including bacterial, viral, or fungal infections
• People with active hepatitis B or C infection (specific testing requirements apply — confirm with trial site)
• People who have had a stroke or bleeding in the brain within 6 months before the first dose of trial medication
• People with a history of bleeding disorders such as haemophilia or von Willebrand disease
• People who require or are currently taking blood-thinning medication such as warfarin or similar vitamin K antagonist drugs
• People who need to take certain strong medications that significantly affect how the liver processes drugs (strong CYP3A inhibitors or inducers) — specific timing restrictions apply (confirm with trial site)
• People who are pregnant or breastfeeding
• People already participating in another treatment clinical trial
• People who require regular use of proton pump inhibitor medications (such as omeprazole, esomeprazole, lansoprazole, or similar acid-reducing drugs)
• People with any other life-threatening illness or condition that the trial doctor believes would make participation unsafe

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