Phase 2 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:

• People who are able to give written consent to participate in the study
• People who have been diagnosed with acute myeloid leukemia (a type of blood cancer)
• People who received a standard first-round chemotherapy treatment (known as "7+3") between 14 and 33 days before starting the trial, and whose bone marrow tests show the leukemia is still present
• People whose doctor does not expect the leukemia to go into full remission without additional treatment
• People whose doctor considers them well enough to handle intensive chemotherapy (similar in strength to the initial 7+3 treatment)
• People whose heart pumping function is at 50% or above, as measured by a heart scan, and whose total lifetime exposure to a class of chemotherapy drugs called anthracyclines is below a specified limit (confirm with trial site)
• People with a physical functioning score of 0, 1, or 2 on a standard medical scale (meaning they are fully active to somewhat limited in strenuous activity)
• People whose liver enzyme levels (AST and ALT) are below five times the upper limit of the normal range for their local laboratory
• People whose bilirubin level (a measure of liver function) is below 1.5 times the upper limit of normal — with an exception for those with a known condition called Gilbert's syndrome
• People whose kidneys are functioning above a certain minimum level, as measured by a standard calculation or blood test (confirm with trial site)
• Women of childbearing potential who agree to use two forms of contraception from the screening visit until six months after the last dose, and who have a documented negative pregnancy test
• Men who are able to father children who agree to either abstain from sex with women of childbearing potential or ensure their partner uses two forms of contraception from screening until six months after the last dose, and who agree not to donate sperm during that same period

Who may not be able to join:

• People diagnosed with a specific subtype of leukemia called acute promyelocytic leukemia (also known as M3 AML)
• People known to have a type of leukemia with certain genetic features called "core binding factor AML" (involving specific chromosomal changes)
• People known to have certain specific genetic mutations (in a gene called TP53) or chromosomal patterns that suggest a particular type of high-risk leukemia
• People whose doctor does not consider them well enough to tolerate intensive chemotherapy
• People who have had a serious (grade 3 or higher) allergic reaction to cytarabine, daunorubicin, or any ingredient in the trial drug
• People with a condition called Wilson's disease or other active problems with how the body processes copper
• People whose total lifetime exposure to anthracycline chemotherapy drugs has already exceeded a specified limit (confirm with trial site)
• People who are pregnant, breastfeeding, or unable to use effective contraception for six months after the last dose of the trial treatment
• People with an infection that is not yet under control (people with infections that are being treated and are under control may still be considered)
• People who have recently received an experimental drug — generally within five half-lives of that drug — or whose side effects from it have not yet settled down to a mild level
• People whose personal, family, social, or geographic circumstances would make it difficult for them to consent, follow the study procedures, or attend required appointments
• People with any other significant medical or psychiatric condition, or abnormal test result, that could prevent safe participation or make the results difficult to interpret
• People with serious uncontrolled heart conditions, including severe heart failure, unstable chest pain, serious heart rhythm problems, a heart attack within the past six months, or signs of acute reduced blood supply to the heart on an ECG
• People currently receiving active treatment for another cancer, with the exception of minor skin cancer surgery or hormonal treatments for certain cancers such as prostate or breast cancer

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