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:

• People who have been diagnosed with a specific type of acute leukemia called acute monocytic leukemia (AML-M5), confirmed using a recognised classification system or by testing for certain markers on the cancer cells
• People who are expected to live for at least 12 weeks at the time of joining
• People who have not previously received treatment for this leukemia
• People who are not suitable for intensive chemotherapy — this includes those aged 60 or older, or those aged 18–59 who have at least one of the following health conditions that makes intensive chemotherapy too risky:
  • A limited ability to carry out daily activities, rated as moderate to significant on a standard medical scale (ECOG score of 2 or 3)
  • A history of heart failure requiring treatment, reduced heart pumping function (ejection fraction of 50% or below), or stable long-term chest pain (angina)
  • Reduced lung function, specifically low carbon monoxide transfer capacity (DLCO ≤65%) or low airflow on breathing tests (FEV1 ≤65%)
  • Moderately reduced kidney function (creatinine clearance between 30 and less than 45 mL/min)
  • Moderate liver impairment, based on a specific blood test result (total bilirubin between 1.5 and 3.0 times the upper limit of normal)
  • Any other health condition that the treating doctor considers incompatible with intensive chemotherapy
  • A personal choice not to receive intensive chemotherapy
• People whose blood test results meet the specific requirements set out in the trial protocol (confirm with trial site)
• People who have not received radiotherapy, chemotherapy, targeted therapy, or a stem cell transplant in the four weeks before joining the trial
• Women who are not pregnant, not breastfeeding, and not planning to become pregnant or donate eggs during the study or for approximately 90 days after the last dose of the study drug
• Women of childbearing potential who agree to use at least one form of birth control specified by the trial protocol
• Men who are sexually active with a female partner who could become pregnant and who agree to use contraception as specified by the trial protocol
• People who are able to understand the study and are willing to sign a consent form

Who may not be able to join:

• People who have a known allergy to the study drug or to drugs with a similar chemical structure
• Women who are pregnant, breastfeeding, or of childbearing age and unwilling to use effective contraception
• People who currently have an active infection
• People who are currently experiencing active bleeding
• People who have had a blood clot, embolism, brain bleed, or similar serious event within the past year before joining
• People with a mental health condition or other circumstance that would prevent them from giving informed consent or following the study requirements
• People with significantly abnormal liver blood test results, or kidney function results above a certain threshold (confirm with trial site for specific values)
• People with a history of certain heart rhythm or electrical problems, a heart attack within the past year, heart failure, or coronary heart disease requiring medication
• People who have had surgery on a major organ within the past six weeks
• People with a history of drug abuse or long-term heavy alcohol use that could affect the study results
• People who have previously received an organ transplant (other than a bone marrow transplant)
• People whom the trial investigator considers unsuitable for the study for any other reason

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