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:

• Adults aged 18 or older at the time of giving consent
• People who have not previously received systemic chemotherapy to treat AML (a blood cancer called acute myeloid leukaemia) — note that certain treatments to temporarily reduce white blood cell counts, such as hydroxyurea or a procedure called leukapheresis, are allowed
• People with a general health and ability-to-function score (called Karnofsky Performance Status) of 70 or above, meaning they are able to care for themselves and carry out most normal activities
• People whose kidneys are working well enough, based on a blood test measuring how well the kidneys filter waste (a result of 30 mL/min/1.73m² or higher)
• People whose liver is functioning within acceptable ranges, based on specific blood test results for liver enzymes and bilirubin (exceptions may apply for certain liver conditions — confirm with trial site)
• People whose heart is functioning well, with a heart function rating of Class I or II (mild or no symptoms), and a pumping strength measurement above 50% on a heart scan
• People who are sexually active and able to have children must agree to use effective contraception or abstain from sex during treatment and for at least 7 months after the final dose of the study drug
• People who are willing and able to give voluntary written consent before any trial-related activities begin

Who may not be able to join:

• People who have already received systemic chemotherapy for AML
• People diagnosed with certain specific types of acute leukaemia, including bi-phenotypic acute leukaemia, mixed lineage leukaemia, or acute promyelocytic leukaemia
• People with active cancer affecting the brain or spinal cord, or symptoms suggesting the cancer has spread there
• People with symptomatic disease that has spread outside the bone marrow (confirm with trial site)
• People with a known history of uncontrolled HIV, or currently active hepatitis B or hepatitis C infection
• People with certain serious heart conditions, including heart failure with symptoms, a heart attack within the past 6 months, unstable chest pain (angina), or a serious uncontrolled irregular heartbeat
• People who currently have another cancer, or who have had a previous cancer with less than one year of being cancer-free — though people with certain adequately treated minor skin cancers or non-invasive cancers (such as early cervical changes) may still be considered regardless of timing
• People for whom the trial drug (CPX-351) would cause them to exceed a lifetime safety limit for a type of chemotherapy called anthracycline (the limit is based on prior treatment history and whether the person has previously had chest radiation)
• People who are currently pregnant, breastfeeding, or planning to become pregnant within 3 months after completing treatment

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