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 been diagnosed with a type of blood cancer called CLL (Chronic Lymphocytic Leukaemia) or SLL (Small Lymphocytic Lymphoma), confirmed using specific internationally recognised diagnostic guidelines from 2018
• People whose CLL/SLL has reached a point where treatment is needed, shown by at least one sign such as: low red blood cell or platelet counts, a very enlarged spleen, very enlarged lymph nodes, immune system problems causing anaemia or low platelets that haven't responded to standard treatment, or certain ongoing symptoms like unexplained weight loss, severe tiredness, prolonged unexplained fevers, or persistent night sweats
• People aged 65 or older
• People who have not previously received treatment for their CLL/SLL (except steroids given for symptom relief or to treat immune-related complications, or rituximab given for immune-related complications)
• People who, if previously treated with rituximab or high-dose steroids for immune complications, have completed that treatment before joining the trial
• People who are on low-dose steroids of no more than the equivalent of 20mg of prednisone per day at the time of joining
• People living with HIV who are on effective HIV treatment and whose virus levels were undetectable within the past 6 months
• People with a history of hepatitis B who have undetectable virus levels while on appropriate treatment
• People who previously had hepatitis C and have been successfully cured, or who are currently being treated for it with undetectable virus levels
• People whose heart function has been assessed and classified as class 2B or better according to a standard heart function rating system (confirm with trial site)
• People whose kidney function meets a minimum threshold, measured by a specific calculation (confirm with trial site)
• People whose liver function, blood cell counts, and protein levels in urine fall within acceptable ranges as determined by blood and urine tests (confirm with trial site)
• People for whom a bone marrow or blood sample can be submitted to a specialised laboratory before the trial begins, to identify specific cancer cell markers needed for ongoing monitoring
• People who have not had major surgery within 7 days, or minor surgery within 5 days, before enrolling in the trial

Who may not be able to join:

• People who have a history of a severe bleeding disorder, or who have previously had a stroke caused by bleeding, or bleeding inside the skull
• People with a known active and progressing disease affecting the brain or spinal cord
• People who are unable to swallow oral (by mouth) medications
• People currently taking the blood-thinning medication warfarin, or who have not been off it long enough before enrolling
• People with an active serious infection caused by a fungus, bacteria, or virus that requires treatment through a drip (intravenous antibiotics), at the time of joining
• People who need to continue taking certain medications that strongly affect how the body processes a particular class of drugs (known as strong CYP3A4/5 inhibitors or inducers), unless those medications have been stopped for at least 14 days or 5 half-lives before starting the trial drug (confirm with trial site)
• People who have had a major heart event such as a heart attack within the 6 months before joining (careful individual assessment would be needed)

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