Phase 2 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 Chronic Lymphocytic Leukaemia (CLL) or Small Lymphocytic Lymphoma (SLL) according to established medical guidelines
• People whose disease has reached a point where treatment is considered necessary according to current CLL guidelines
• People whose disease is scored as intermediate or high risk using a specific risk scoring system called the CLL-BALL Risk Model, which takes into account certain blood test results, anaemia levels, and how recently previous treatment was completed (confirm with trial site)
• People who have already received at least one prior course of treatment for CLL
• People aged 18 years or older
• People who are generally well enough to carry out basic daily activities (confirm with trial site)
• People whose liver, kidneys, and other organs are functioning at an adequate level based on specific blood tests
• People whose bone marrow is producing enough blood cells at a minimum level, unless low counts are clearly due to the CLL itself (as determined by the treating doctor)
• Women who could become pregnant must have a negative pregnancy blood test within 7 days before starting treatment
• People who are willing to use highly effective contraception during the study and for a defined period after the last dose of each study drug — up to 90 days after the last dose of acalabrutinib or venetoclax, or 18 months after the last dose of obinutuzumab, whichever is later. Note: periodic methods such as calendar tracking and withdrawal are not considered acceptable.
• People who are willing to not donate sperm or eggs during the entire treatment period and after treatment ends
• People who are willing and able to give written informed consent to participate

Who may not be able to join:

• People who have previously been treated with a BTK inhibitor (such as acalabrutinib) or a BCL2 inhibitor (such as venetoclax), unless a very specific exception applies — for example, people who achieved undetectable disease or complete remission from prior BCL2 inhibitor treatment may still be considered eligible (confirm with trial site). Note: prior BTK inhibitor treatment alone does not qualify for this exception.
• People who have had a severe allergic reaction to obinutuzumab or any of its ingredients
• People who are currently taking part in another clinical trial, unless specifically approved by the lead study investigator
• People whose CLL has transformed into a more aggressive type of lymphoma (known as Richter's transformation)
• People who have been diagnosed with another active cancer, or who have received systemic treatment for another cancer within the past 3 years. Some localised treatments (such as surgery or targeted radiation with a curative aim) within that period may be permitted, and low-risk prostate cancer being managed with active surveillance may also be permitted (confirm with trial site).
• People with serious uncontrolled medical conditions, such as active infections, heart failure, unstable chest pain, irregular heart rhythms, or significant mental health or social circumstances that would make it difficult to follow the study requirements
• People with a known active infection of any kind at the time of enrolment, or who have required hospital treatment or intravenous antibiotics for an infection within 2 weeks before starting the study
• People with a known bleeding disorder
• People who are pregnant, as the study drugs carry potential risks to an unborn baby
• People who are breastfeeding, as the potential risk to a nursing infant is unknown
• People who have had a major surgical procedure within 4 weeks before joining the study, or who are expected to need major surgery during the study
• People who have had bleeding in the brain or a stroke within the past 6 months
• People with a history of a serious brain condition called Progressive Multifocal Leukoencephalopathy (PML)
• People with a known HIV infection, or active hepatitis B or hepatitis C infection. People with a past or hidden hepatitis B infection may be considered if certain blood DNA tests show the virus is undetectable and they are willing to take preventive antiviral medication and have monthly testing. People who have had hepatitis C exposure may be considered if a specific blood test confirms the virus is no longer active (confirm with trial site).
• People with severe heart failure classified as New York Heart Association Class III or IV
• People with significant liver disease, including hepatitis, current alcohol misuse, or cirrhosis
• People who have received a live-virus vaccine within 28 days before starting the study, or who would need a live-virus vaccine at any point during the study
• People with a known condition that would prevent them from properly absorbing oral medications
• People with psychiatric or social circumstances that would make it difficult to follow the study schedule
• People who have taken certain medications that strongly affect how the body processes specific drugs (CYP3A, CYP2C8, CYP2C9, and CYP2C19 inhibitors or inducers) within 7 days before the first dose (confirm with trial site)
• People who have consumed grapefruit, grapefruit products, Seville oranges (including marmalade), or star fruit within 3 days before the first dose
• People who require dual antiplatelet therapy or blood-thinning treatment with warfarin

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