Phase 1 Leukaemia Trial, Recruiting

Written by an AI model from the 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 have acute myeloid leukemia (AML) or a blood/bone marrow condition called MDS that has come back or stopped responding to treatment (this applies to Groups 1 and 2 of the trial)
• You have high-risk MDS that has not yet been treated (or has had no more than one cycle of a specific type of chemotherapy called a DNMTi), and your disease is considered high or very high risk by standard scoring systems (this applies to Group 3)
• If your AML has a specific gene change (FLT3, IDH1, or IDH2), you must have already tried — or been unable to tolerate — an approved targeted drug for that mutation
• You are 18 years of age or older
• You are well enough to carry out some daily activities (your doctor will assess this using a standard scale; a score of 3 or below is required)
• Your liver is working well enough, based on blood test results within acceptable ranges (confirm with trial site)
• Your kidneys are working well enough, based on a blood test measuring how well they filter (confirm with trial site)
• If you are a woman who could become pregnant, you must agree to use effective contraception before, during, and for several months after the trial — and have a negative pregnancy test before starting
• If you are a man, you must agree to use effective contraception during and for several months after the trial
• If you have HIV, your virus must be undetectable on treatment within the last 6 months
• You are willing and able to sign a consent form (or have a legal representative do so on your behalf)
• You may have had another cancer in the past, as long as it does not interfere with this trial's treatments or results

Who may not be able to join:

• You are still experiencing significant side effects from a previous cancer treatment (above a mild level), not counting hair loss or abnormal blood counts
• You are currently taking part in another clinical trial using an experimental treatment
• You have received anti-cancer treatment within the last 14 days before starting the trial (some exceptions apply, confirm with trial site)
• You are taking certain medications that strongly affect how the body processes drugs (called strong CYP3A4 inhibitors or inducers — including grapefruit juice, some antifungals, and some antibiotics), and these cannot be stopped at least 5 days before starting treatment
• You are taking certain other specific medications that affect particular liver enzymes (FMO1 or FMO3), and these cannot be stopped at least 5 days before starting treatment
• You have had a serious allergic reaction to medications chemically similar to the drugs used in this trial
• You have an active hepatitis B or hepatitis C infection that requires ongoing treatment
• You have another serious illness or condition that would make it unsafe for you to participate
• You are pregnant or breastfeeding
• You have a specific type of leukemia called acute promyelocytic leukemia (APL)
• You have leukemia that has spread to your brain or spinal cord and is causing symptoms
• You have life-threatening complications from your blood cancer, such as uncontrolled bleeding or a severe uncontrolled infection
• You have had a serious heart problem in the last 6 months, such as severe heart failure, a heart attack, or a stroke
• A recent heart scan shows your heart pumping function is below a certain level (less than 40%)
• You have difficulty swallowing pills or a digestive condition that prevents you from absorbing oral medications properly
• You have an active infection (bacterial, fungal, or viral) that is not improving with treatment
• A recent heart tracing (ECG) shows an abnormal heart rhythm measurement (QTc interval of 480 ms or more), or you have a known family history of a specific inherited heart rhythm condition

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