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 are willing and able to sign a consent form and follow all study procedures for the full duration of the trial
• People aged 18 to 70 years who have been newly diagnosed with acute myeloid leukaemia (AML) of any risk level, as defined by standard medical guidelines (ELN 2017)
• Women who could become pregnant must use highly effective contraception from enrolment, throughout the study, and for 6 months after the last dose of study treatment
• Women who could become pregnant must have a negative pregnancy test (blood or urine) within 24 hours before starting study treatment
• Men who could father a child must use condoms or other effective contraception during the study
• People whose leukaemia cells carry a protein called CD33, confirmed by laboratory testing
• People who are well enough to receive intensive chemotherapy, as assessed by their treating doctor (with a fitness score of 0, 1, or 2 on a standard medical scale)
• People who have had a previous cancer are eligible, as long as it does not need treatment at the same time — ongoing hormonal therapy for another cancer is an exception and is allowed
• People who previously received certain pre-AML treatments (azacitidine or decitabine), provided the last dose was at least 14 days before the study starts
• People whose kidneys, liver, and other organs are functioning at an acceptable level, as determined by the trial site
• People with a heart pumping function of at least 50%, confirmed by a heart scan
• People who have taken a medication called hydroxyurea to reduce blood cell counts before starting the study

Who may not be able to join:

• People who have previously received treatment for AML, other than hydroxyurea and/or a blood-filtering procedure called leukapheresis
• People diagnosed with a specific subtype of leukaemia called acute promyelocytic leukaemia (APL)
• People with leukaemia that has spread to the brain or spinal cord and is currently active
• People with serious liver conditions, such as cirrhosis, non-alcoholic steatohepatitis, sclerosing cholangitis, or a condition called Wilson's disease
• People with a currently active hepatitis B or hepatitis C infection
• People with a known allergy to the components of either study drug (cytarabine, daunorubicin, or gemtuzumab ozogamicin)
• People whose past exposure to a certain class of chemotherapy drugs (anthracyclines) is close to or exceeds safe limits, including limits that are lower for people who have had chest radiation (confirm with trial site)
• People who are medically unstable and require medications to maintain blood pressure
• People who have taken another experimental drug within the 14 days before joining the trial
• People with serious heart conditions, including severe heart failure, chest pain at rest, newly developed chest pain within the last 3 months, or a heart attack within the past 6 months
• People whose ability to understand and consent to the study, or to follow study procedures, is affected by any condition
• People with substance abuse issues or severe uncontrolled medical, social, or psychiatric conditions that could interfere with completing or evaluating the study
• Women who are pregnant or breastfeeding
• People whose leukaemia has a specific genetic change known as a FLT3 ITD or FLT3 TKD mutation

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