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:

• You are 18 years of age or older
• If you are a woman who could become pregnant, you must be using reliable birth control during the study and for 30 days after your last dose of study medication, or you must have gone through menopause or had a surgical procedure that means you cannot become pregnant
• If you are a man, you must agree to use reliable birth control during the study and for at least 30 days after your last dose of study medication
• You have been diagnosed with a specific type of blood cancer called Acute Myeloid Leukemia (AML) — either newly diagnosed, a second occurrence, one that came back after treatment, or one that did not respond to treatment
• Your doctor has decided that standard intensive chemotherapy is not appropriate for you, or you have chosen not to receive it
• Your doctor believes you are suitable to receive the two study drugs (venetoclax and decitabine)
• Your white blood cell count is at or below a certain level at the start of the study (medication may be used beforehand to bring this down if needed)
• Your liver is working well enough, based on blood tests showing liver enzyme and bilirubin levels within acceptable ranges (confirm with trial site)
• Your kidneys are working well enough, based on a kidney function test result of at least 40 ml/min
• Your general physical ability and daily functioning falls within an acceptable range on a standard scale used by doctors (scores 0, 1, or 2 out of 5)
• You have recovered from any side effects of previous surgery, radiation, or cancer treatment (hair loss is an exception)
• You are willing and able to sign a consent form agreeing to take part

Who may not be able to join:

• You currently have another active cancer (other than AML) that has been treated with chemotherapy or immunotherapy in the past 12 months (non-invasive skin cancers that are not melanoma are generally still allowed)
• You have an active form of leukemia that has spread to the fluid around your brain and spinal cord and requires treatment injected into that fluid
• You have leukemia that is only present outside the bone marrow and does not meet the standard bone marrow criteria for this type of leukemia (confirm with trial site)
• You have a specific subtype of AML called Acute Promyelocytic Leukemia (APL) with a particular genetic marker
• You have a type of blood cancer called Chronic Myeloid Leukemia (CML) at any stage
• You have received any cancer treatment in the 14 days before starting the study (some short-acting medications may be allowed closer to the start date — confirm with trial site)
• You have an active infection that is not being controlled with treatment
• You have taken part in another clinical trial or received an experimental treatment within the past 30 days
• You are a woman who could become pregnant and have tested positive for pregnancy, are breastfeeding, or plan to become pregnant or breastfeed during the study or within 30 days after your last dose
• You have a serious ongoing medical or mental health condition that your doctor believes would make it difficult for you to complete the study
• You have an active hepatitis B infection, hepatitis C infection, or HIV
• You have had a serious allergic reaction to either of the study drugs (venetoclax or decitabine) in the past, unless your doctor and the study team decide it is not relevant
• You have certain serious heart conditions, including severe heart failure, uncontrolled high blood pressure, significant irregular heartbeat, or an abnormal heart electrical reading (confirm with trial site)
• In the past 6 months, you have had a heart attack, unstable chest pain, heart or artery bypass surgery, a stroke, or a mini-stroke
• You have had seizures within the past 2 months that are not controlled
• You are unable to avoid receiving live vaccines during and after treatment until your immune system has recovered
• You are unable or unwilling to cooperate with the study team or follow the study requirements for any reason

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