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 fully informed about the study and have voluntarily signed a consent form.
• People who have been newly diagnosed with a specific type of acute myeloid leukaemia (AML) according to 2022 WHO criteria, or people with AML that has come back or stopped responding to treatment and who were previously treated with a type of drug called a menin inhibitor — and whose AML has certain genetic features (NPM1 mutation, NUP98 rearrangement, or KMT2A rearrangement) and is classified as intermediate or high risk.
• People aged 18 years or older.
• People with a physical functioning level that falls within the acceptable range for their assigned study group (confirm with trial site for exact performance score requirements).
• For one group of participants (Group B): people who are considered unable to tolerate intensive chemotherapy, either because they are 75 or older, or because they have certain heart, lung, kidney, or liver conditions, or a lower physical functioning score.
• For another group of participants (Group C): people whose AML did not respond to, or came back after, previous treatment with a menin inhibitor.
• People whose liver, kidney, and heart are functioning at an adequate level as defined by specific blood and imaging tests (confirm with trial site for exact values).
• People whose blood clotting test results during screening, if elevated, have been further investigated to rule out blood clot conditions before joining.
• People who, in the investigator's judgement, are expected to survive for more than 12 weeks.
• People who are willing and able to attend all required study visits.
• People of childbearing potential, or people whose female partners are of childbearing potential, who agree to use effective contraception throughout the study and for 30 days after the last study dose (postmenopausal women over 45 with more than one year since their last period, and surgically sterilised women, are exempt from this requirement).
• For Groups B and C: people whose white blood cell count in the blood is at or below a certain level (with a medication called hydroxyurea permitted to help control this).

Who may not be able to join:

• People who have leukaemia that has spread to the central nervous system (brain and spinal cord).
• People with a known history of significant liver disease, including hepatitis or cirrhosis — though people with hepatitis B or C may still be considered if specific virus tests come back negative (confirm with trial site).
• People known to be infected with HIV.
• People who are pregnant (based on a positive pregnancy test during screening) or currently breastfeeding.
• People with certain heart conditions, including a hereditary condition affecting heart rhythm, an abnormal heart rhythm reading (QTcF above 450 msec), a recent heart attack, unstable chest pain, recent heart bypass surgery (within 6 months), or moderate-to-severe heart failure.
• People who have had another cancer in the past 5 years, with the exception of certain fully treated skin, breast, or cervical cancers.
• For Groups A and B: people who have already received treatment aimed at leukaemia, apart from a few specific exceptions such as hydroxyurea to control white blood cell counts, or a short course of a specific medication given when acute promyelocytic leukaemia was initially suspected.
• For Group C: people who received anti-leukaemia treatment too recently before the study start date, or who have had certain stem cell or immune cell therapies within specific time windows and have not yet recovered from related side effects (confirm with trial site for exact timeframes).
• For Groups A and B: people who have previously been treated with a menin-targeted therapy.
• People who still have side effects from previous treatments that have not returned to a mild or resolved level (hair loss is an exception).
• People who had a chest scan within the past month showing lung nodules and who then tested positive on a tuberculosis screening test.
• People with an active, uncontrolled infection that is serious and has not been adequately treated (some minor or well-managed infections may still be acceptable — confirm with trial site).
• People who have difficulty swallowing, severely reduced bowel length, slow stomach emptying, or other conditions that would prevent them from taking oral medications or absorbing them properly.
• People with a known severe allergy to menin inhibitors or to any ingredient in the study drug BN104.
• People who, in the investigator's judgement, are unlikely to follow the study requirements reliably.
• People who have any other medical condition, abnormal test result, or other factor that the investigator believes makes participation unsafe or would interfere with the study results.

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