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 acute myeloid leukemia (AML) or a related high-grade blood cancer, including certain mixed-type acute leukemias, based on recognised medical classification systems
• For the first part of the trial (Phase I): People who are newly diagnosed and whose disease is classified as high-risk, OR people whose disease has come back or stopped responding to treatment and who need further therapy, with detectable cancer cells in the blood or bone marrow
• For the second part of the trial (Phase II): People who are newly diagnosed and whose disease is classified as high-risk according to 2022 guidelines
• People aged 18 years or older
• People whose liver enzyme levels (AST and ALT) are within an acceptable range — no more than 3 times the upper limit of normal
• People whose bilirubin (a liver marker) is within an acceptable range, unless any elevation is due to a known harmless condition called Gilbert's syndrome or an unrelated cause
• People whose kidneys are functioning well enough, as measured by a standard calculation or urine test (confirm with trial site)
• People whose heart is pumping adequately, confirmed by a heart scan done within the past 3 months or after recent relevant treatment
• People who are reasonably well and able to carry out daily activities, based on a standard medical scale (ECOG score of 0, 1, or 2)
• People whose risk score for treatment-related serious complications falls below a certain threshold (confirm with trial site)
• Women who could become pregnant must have a negative pregnancy test before joining, and both women and men who could father or become pregnant must agree to use effective contraception from the time of signing the consent form until at least 3 months after the last dose of study treatment
• People who are able to understand the trial and are willing to sign a consent form
• People whose white blood cell count in the blood is below a certain level before starting treatment — if needed, medications may be given beforehand to bring this count down

Who may not be able to join:

• People with a specific type of leukemia called acute promyelocytic leukemia, or chronic myeloid leukemia that has progressed to a blast crisis
• People whose leukemia has spread to the brain or spinal cord
• People with another serious illness that is expected to significantly limit survival regardless of leukemia treatment
• People with an active, uncontrolled infection — though people with infections being successfully treated, or fever thought to be caused by the leukemia itself, may still be considered; people with active hepatitis B or C requiring treatment would generally not be eligible
• People who are known to be allergic to any of the study medications
• People who are pregnant or breastfeeding
• People currently taking part in another clinical trial involving an experimental treatment
• People who are known to be HIV positive
• People who cannot stop taking certain medications that interact with one of the study drugs (called CYP3A inhibitors) before the first treatment day — with one specific exception (voriconazole)
• People who have used steroid medications to treat cancer within the 7 days before the first dose of one of the study drugs (venetoclax)
• People who have consumed grapefruit, Seville oranges (including marmalade made with Seville oranges), or star fruit within 3 days before the first dose of venetoclax

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