Phase 4 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 at the time of signing the consent form
• People whose general ability to carry out daily activities falls within a certain range, as measured by a standard cancer performance scale (scores 0 to 3)
• People whose heart's pumping function is below 50%, as measured by an echocardiogram (heart ultrasound)
• People who have been diagnosed with chronic lymphocytic leukaemia (CLL)
• People who are either newly diagnosed and have not yet been treated, or whose CLL has come back or stopped responding to treatment, and who have had no more than 2 previous rounds of CLL-specific treatment
• People whose CLL is currently active and meets specific medical guidelines that indicate treatment is needed (iwCLL 2018 criteria)
• People whose blood test results meet certain minimum levels, including white blood cell counts, platelet counts, liver function values, and kidney function values (confirm exact thresholds with trial site)
• People who are sexually active and capable of having children must be willing to use highly effective contraception during the study and for 2 days after the last dose of the study drug acalabrutinib
• People who are willing and able to attend all required study visits, follow the study rules, and provide written consent to participate and to allow use of their health information for research purposes

Who may not be able to join:

• People with active leukaemia that has spread to the brain or spinal cord, or who have spinal cord compression (those with a past history of this who were treated may still be considered eligible if there is no current sign of brain or spinal involvement, confirmed by specific tests — confirm with trial site)
• People whose CLL has transformed into a more aggressive type of cancer (known as Richter's transformation) that is currently active
• People who have previously been treated with a type of drug called a BTK inhibitor
• People who have had major surgery within 30 days before the first dose of the study treatment
• People with uncontrolled haemolytic anaemia (a condition where red blood cells are being destroyed faster than they can be replaced, and it is not being managed)
• People who have taken another experimental drug within 30 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment
• People who have received a live virus vaccine within 28 days before the first dose of the study treatment
• People with a history of, or currently confirmed, a serious brain infection called progressive multifocal leukoencephalopathy (PML)
• People with a history of another cancer, unless: that cancer has shown no signs of activity for more than 3 years and is considered low risk by their treating doctor; it was a specific type of skin cancer that was fully treated with no current signs of disease; or it was a fully treated early-stage cervical or prostate cancer with no current signs of disease
• People who are unable to swallow tablets, or who have conditions that significantly affect the stomach or intestines, such as removal of the stomach or small bowel, gastric bypass surgery, active inflammatory bowel disease, or bowel obstruction
• People with an active, uncontrolled infection (bacterial, fungal, viral, or other type) or a significant localised infection
• People with a known history of HIV infection
• People with active hepatitis B or hepatitis C infection (some people with certain hepatitis antibody results may still be considered if specific blood tests come back negative — confirm with trial site)
• People who have had a stroke or bleeding in the brain within the 6 months before joining the trial
• People with a history of bleeding disorders, such as haemophilia or von Willebrand disease
• People who require or are currently taking blood-thinning medication called warfarin or similar vitamin K-blocking drugs within 7 days of the first study dose (certain other types of blood thinners, such as DOACs or low molecular weight heparins on a stable dose, may be permitted — confirm with trial site)
• People who need treatment with certain medications that strongly interact with a liver enzyme called CYP3A, or who have taken strong CYP3A-affecting drugs within 1 to 3 weeks before the first study dose (confirm specific timeframes with trial site)
• People who are pregnant or breastfeeding
• People who are currently taking part in another treatment clinical trial
• People with uncontrolled heart or cardiovascular conditions, including uncontrolled abnormal heart rhythms requiring new treatment within the last month, significantly abnormal heart electrical readings (QTcF above 470 ms or below 330 ms), unstable heart disease or a recent heart attack or unstable chest pain within the last 3 months, or a heart procedure or bypass surgery within the last month
• People with high blood pressure that cannot be controlled even with appropriate treatment
• People with any other serious illness, medical condition, organ problem, or lifestyle factor that, in the investigator's opinion, could put them at risk or make it difficult to follow the study requirements

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