Phase 2 Leukaemia Trial, Recruiting

Written by an AI model from the 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 who have been diagnosed with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).
• People whose CLL or SLL is considered active and needs treatment, shown by at least one of the following: worsening anaemia or low platelet counts; a very enlarged spleen causing symptoms; very enlarged lymph nodes or worsening swollen glands; rapidly increasing white blood cell counts; or symptoms such as unintentional weight loss of more than 10% in 6 months, severe tiredness, unexplained fevers for 2 or more weeks, or night sweats lasting more than a month without infection.
• People whose CLL or SLL has come back or stopped responding after at least one previous treatment (completing at least 2 cycles of a standard or approved investigational treatment).
• People whose blood counts and organ function meet certain minimum levels set by the trial, including white blood cell counts, red blood cell levels, platelet counts, liver function, and kidney function (confirm specific values with trial site).
• People who are physically well enough to carry out everyday activities, as measured by a standard medical scale (ECOG score of 0, 1, or 2).
• Women who could become pregnant must agree to use highly effective contraception during treatment and for 30 days after the last dose of either study drug.
• People who are able to swallow capsules or tablets without difficulty.
• People who are willing and able to follow all study procedures and who can give written informed consent.

Who may not be able to join:

• People with a related blood cancer called prolymphocytic leukaemia, or those with a suspected or confirmed transformation of their CLL into a more aggressive cancer (Richter's transformation).
• People whose CLL or SLL got worse while they were being treated with a BTK inhibitor (a type of targeted cancer drug).
• People whose CLL or SLL got worse while they were being treated with venetoclax.
• People who previously could not tolerate acalabrutinib or venetoclax due to side effects.
• People with another active cancer requiring treatment, unless it is an early-stage skin cancer, cervical cancer in situ, low-grade prostate cancer, or a cancer from which the person has been free for 2 or more years (confirm details with trial site).
• People with serious heart conditions, such as uncontrolled irregular heartbeat, heart failure, or a heart attack within the past 6 months, or certain abnormal heart rhythm readings on an ECG.
• People with conditions that significantly affect the stomach or bowel in a way that could prevent medication from being properly absorbed, such as bowel obstruction or certain types of bariatric (weight loss) surgery — though people who have had such surgery may still be eligible if their doctor confirms absorption is not affected.
• People with a known severe allergic reaction to acalabrutinib or venetoclax.
• People with active bleeding, a bleeding disorder such as haemophilia or von Willebrand disease, or those currently taking blood-thinning medications called warfarin or similar vitamin K antagonists.
• People with abnormal blood clotting results above a certain level (confirm details with trial site).
• People with uncontrolled autoimmune conditions affecting red blood cells or platelets (such as autoimmune haemolytic anaemia or immune thrombocytopenic purpura).
• People diagnosed with a stomach ulcer (confirmed by a camera test) within the 3 months before joining the trial.
• People who need to take certain medications that strongly interact with the study drugs through the liver's CYP3A4 enzyme system (confirm specific medications with trial site).
• People who need to take proton pump inhibitor medications (such as omeprazole or pantoprazole) at the time of joining, if they are taking the capsule form of acalabrutinib — though switching to a different type of stomach acid medication may make a person eligible (confirm with trial site).
• People who have had a stroke or bleeding in the brain within the 6 months before starting treatment.
• People who have had major surgery within 7 days before starting treatment, or who have not yet fully recovered from a recent surgery.
• People with certain active hepatitis B or hepatitis C infections, based on specific blood test results (confirm details with trial site).
• People who are pregnant or currently breastfeeding.
• People already taking part in another treatment clinical trial.
• People with a known HIV infection, or any active serious infection (bacterial, viral, or fungal).
• People whose CLL or SLL has spread to the central nervous system (brain and spinal cord).
• People with a history of a serious brain condition called progressive multifocal leukoencephalopathy (PML).

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