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:

• Adults aged 18 or older who have been diagnosed with AML (a type of blood cancer), confirmed by laboratory testing of tissue or cells
• People who are able to understand the trial and sign a written consent form before any study procedures begin
• People who are able to swallow and keep down tablets or capsules
• People whose health is expected to allow them to complete at least one full 28-day round of treatment
• People who are reasonably active and able to care for themselves, based on a standard medical fitness scale (score of 0–2 out of 4)
• People whose other medical conditions have been stable and well-managed for at least 28 days before starting the trial drug
• People with confirmed AML, a related blood condition called MDS, or CMML, whose disease has come back or stopped responding to previous treatments, and for whom no other approved treatments are available or suitable
• People with a specific type of AML that does not have a mutation in a gene called FLT3 (known as FLT3 wild-type AML), whose disease has returned or is not responding to treatment
• People with relapsed or treatment-resistant AML who have previously been treated with certain blood cancer medicines (such as venetoclax, hypomethylating agents, or FLT3 inhibitors including gilteritinib, midostaurin, quizartinib, or sorafenib)
• People whose gene mutation profile has been tested and is on record before entering the trial
• Women who are either unable to become pregnant, or who agree to use highly effective contraception from the screening period until 6 months after the last dose of the trial drug
• Men who agree to use double-barrier contraception from enrolment through treatment and for 6 months after the last dose of the trial drug

Who may not be able to join:

• People with suspected cancer that has spread to the brain or the lining around the brain, especially if it is causing symptoms, has not been treated, or currently requires active treatment
• People with a specific subtype of leukaemia called acute promyelocytic leukaemia (also known as APL or FAB M3)
• People who have received systemic anti-cancer treatment for this disease within the 2 weeks before the first dose of the trial drug (a longer washout period of up to 3 weeks may apply for certain long-acting medicines; a drug called hydroxyurea is an exception and may be permitted)
• People who are still experiencing significant side effects from previous cancer treatments that have not improved to a mild level, with some exceptions at the doctor's discretion (such as hair loss or certain moderate side effects)
• People who have had a stem cell or bone marrow transplant within the past 90 days, or who are still taking medicines to suppress the immune system following a transplant within the past 2 weeks
• People whose kidneys are not functioning well enough (kidney filtration rate below a certain level, confirmed by blood tests)
• People whose liver function tests show the liver is not working well enough, based on specific blood test results being above acceptable levels (confirm with trial site for exact values)

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