Phase 1 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 newly diagnosed with a high-risk form of acute myeloid leukemia (AML) or a related blood disorder (MDS/AML), confirmed by a specialist lab review, or people whose AML has come back or stopped responding after one previous treatment and still has at least 5% abnormal blood cells (blasts) present.
• People newly diagnosed with AML who are aged 75 or older, or aged 18 to 74 and either do not wish to receive, or are not considered suitable for, intensive chemotherapy due to health conditions such as heart problems, reduced lung function, reduced kidney function, liver problems, low physical functioning, or other serious health issues judged by the doctor to make intensive chemotherapy unsuitable.
• People newly diagnosed with AML who have at least 10% abnormal blood cells (blasts) in their bone marrow.
• People newly diagnosed with AML who have not previously received certain specific treatments known as hypomethylating agents (HMAs) or venetoclax (VEN) for this disease.
• People who have not received any other disease-targeting treatment (other than hydroxyurea or low-dose cytarabine) for at least 14 days before joining the study.
• People whose physical functioning meets specific levels based on age and disease status — the trial site can confirm the exact requirements (confirm with trial site).
• People with a life expectancy of at least 3 months.
• People whose liver, kidney, and blood-clotting functions fall within the ranges required by the trial (confirm with trial site for specific values).
• People with a heart pumping function (left ventricular ejection fraction) of at least 40%, confirmed by an ultrasound of the heart.
• People whose white blood cell count is within an acceptable range (medication to bring the count down beforehand may be allowed).
• People who are willing and able to follow the dietary and other requirements of the study.
• People who understand the study and are willing to sign a consent form.

Who may not be able to join:

• People diagnosed with a specific subtype of leukemia called acute promyelocytic leukemia.
• People with a subtype called core binding factor AML who are considered suitable for intensive chemotherapy.
• People newly diagnosed with AML who are eligible for and willing to receive the standard HMA/venetoclax treatment combination.
• People who have any signs or suspicion of leukemia affecting the brain or spinal cord.
• People who have previously been treated with certain specific drugs including azacitidine, decitabine, venetoclax, or FHD-286 — though for people whose AML has returned or stopped responding, prior use of azacitidine, decitabine, and venetoclax may be permitted (confirm with trial site).
• People who are currently pregnant or breastfeeding, or women of childbearing potential who do not have a negative pregnancy test within 72 hours before starting treatment.
• People who are planning to become pregnant within one year of starting the study treatment.
• People with serious uncontrolled health conditions that could affect their safety or ability to complete the study, including uncontrolled active infections, uncontrolled other cancers, certain heart rhythm or electrical abnormalities, severe heart failure, unstable chest pain (angina), new or unstable irregular heartbeat, severe liver disease, or significant mental health or personal circumstances that would make it hard to follow the study requirements.
• People who are unable to swallow oral (by mouth) medication or who have digestive system problems that would prevent the study drug from being properly absorbed.
• People currently taking certain medications that strongly affect how the body processes drugs (known as strong CYP3A inhibitors or inducers), or certain other medications with a narrow safe dosing range — the trial site can advise on specific medications (confirm with trial site).
• People currently taking proton pump inhibitors (a common type of medication for acid reflux or stomach ulcers) unless they are able to switch to a different type of acid-reducing medication at least 7 days before joining.
• People of childbearing potential who are sexually active with male partners, or fertile males who are sexually active with people of childbearing potential, who are unwilling to use two forms of contraception from screening until the required time after the last dose, or who are unwilling to refrain from donating eggs or sperm during this period.
• People with an uncontrolled active HIV infection — though people with HIV who have an undetectable viral load, no active opportunistic infections, a sufficient immune cell count, and who are on a stable HIV treatment regimen may still be considered (confirm with trial site).
• People with active hepatitis B or hepatitis C infection, unless hepatitis C has been successfully treated or there is evidence of immunity to prior hepatitis B infection.
• People with a known allergy or sensitivity to any of the study drugs or their ingredients.

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