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 a type of blood cancer called CLL (chronic lymphocytic leukaemia) or SLL (small lymphocytic lymphoma) that meets standard 2018 diagnostic guidelines and currently needs treatment — including some cases where standard lab test results look slightly unusual but other genetic tests support the diagnosis.
• People whose CLL/SLL falls into one of two groups: either those who have already received at least one prior treatment (such as a BCL2 inhibitor, chemotherapy, or a BTK inhibitor), OR those who were previously treated with a BTK inhibitor and have a specific type of genetic change known as a BTK gatekeeper mutation at the T474 location (confirm with trial site).
• People aged 18 or older.
• People who are reasonably well and able to carry out daily activities, as measured by standard medical scoring tools (confirm with trial site).
• People whose blood counts and organ function (including liver and kidney) meet minimum levels set by the trial — in some cases, lower blood counts may still be acceptable if the CLL itself is causing them.
• People who are able and willing to use at least one reliable form of birth control throughout the study and for 30 days after finishing the study drug — this applies to women who could become pregnant and to men who have not been sterilised.
• Women who could become pregnant must have a negative pregnancy test within 7 days before starting the study drug.
• Men who have not been sterilised must not donate sperm from the start of the study drug until 30 days after the last dose.
• People who are able to give informed consent to participate.

Who may not be able to join:

• People whose CLL/SLL has transformed into a more aggressive cancer called Richter's transformation that is currently active.
• People who have received cancer treatment, investigational therapy, or who have not recovered from significant side effects of a previous treatment within a certain time period before starting the study drug (the exact timeframe depends on the treatment — confirm with trial site).
• People with serious uncontrolled health conditions that, in the opinion of the trial doctor, would make participation unsafe.
• People who need to take blood-thinning medication called warfarin or similar vitamin K antagonist drugs.
• People who have had major surgery within 14 days before starting the study drug.
• People who have recently taken certain medications that can interfere with how the study drug works in the body, including high-dose steroids for cancer treatment, certain drugs that affect liver enzymes (CYP3A4 or CYP2C8), or who have recently had CAR T-cell therapy (specific waiting periods apply — confirm with trial site).
• People who have eaten grapefruit, Seville oranges (including marmalade made with them), or star fruit within 3 days before starting the study drug.
• People who regularly take stomach acid-reducing medications such as proton pump inhibitors or H2 blockers, unless strict timing rules around the study drug can be followed (confirm with trial site).
• People who have certain significant heart rhythm problems or a QT interval measurement of 480ms or more on a heart tracing (ECG).
• People with serious heart conditions such as uncontrolled irregular heartbeat, heart failure, or a heart attack within the past 6 months, or with significantly reduced heart pumping function.
• People who have had a stroke or bleeding in the brain within the past 6 months.
• People who have had a stem cell transplant within the past 60 days, are still on immune-suppressing drugs after a transplant, or are experiencing significant graft-versus-host disease.
• Women who are pregnant, planning to become pregnant during the study, or currently breastfeeding.
• People with conditions that significantly affect the ability to absorb medication through the digestive system, such as removal of part of the stomach or small bowel, ulcerative colitis, or bowel obstruction.
• People with a known allergy to any ingredient in the study drug LP-168.
• People with an active bleeding disorder that is not well controlled (note: well-controlled conditions like Von Willebrand's disease or haemophilia do not automatically exclude someone).
• People with uncontrolled active infections (bacterial, fungal, or viral), poorly controlled HIV (defined as a CD4 count below 200), or active hepatitis B or C infection.
• People with an unexplained fever above 38.3°C in the 7 days before starting the study drug (unless the trial doctor determines it is caused by the cancer or a known infection).
• People who have had another active cancer in the past year — though several exceptions apply, including certain skin cancers, cancers treated with curative intent, and some cancers on stable hormonal therapy (confirm with trial site).

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