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 newly diagnosed with acute myeloid leukaemia (AML) that has not been treated before (a new, first-time diagnosis).
• People whose AML does not have certain specific genetic changes (no MRC-defining cytogenetic lesions, no t(15;17), t(8;21), inv(16), or t(16;16)) (confirm with trial site).
• People whose AML does not have changes in the NPM1 gene or the FLT3 gene.
• People who have not received prior treatment for their AML, except possibly a short course of a medication called hydroxyurea if their white blood cell count was very high or they had tumour-related symptoms.
• People aged 50 years or older.
• People who are reasonably well and able to carry out daily activities, as measured by a standard medical scale called the ECOG performance status score of 2 or below (confirm with trial site).
• People whose heart, liver, kidneys, and other organs are functioning well enough, as shown by specific blood test results outlined in the trial protocol.
• Women who could become pregnant must have a negative pregnancy blood test within 72 hours before starting treatment, and must not be breastfeeding at the time of joining the trial.
• Women who are post-menopausal, have not had a period for more than 2 years, have been surgically sterilised, or are willing to use two effective forms of barrier contraception throughout the trial.
• Men who are willing to use an effective form of contraception for the full duration of the trial and for 3 months after the last dose of study treatment.
• People who are able to attend regular blood tests, assessments, and appointments at the treating hospital for the full duration of the trial.
• People who are able to understand the trial information and are willing to sign a consent form agreeing to take part.
• People who are registered with the French Social Security system.

Who may not be able to join:

• People who have a previous diagnosis of certain related blood or bone marrow conditions, including MDS, MPN, MDS/MPN, or therapy-related AML.
• People who have previously had radiotherapy or chemotherapy for a solid tumour or lymphoma (though local radiotherapy for prostate cancer may be an exception — confirm with trial site).
• People who currently have an active infection that is not under control.
• People who have certain serious or uncontrolled health conditions, including severe heart failure, unstable chest pain, uncontrolled irregular heartbeat, pancreatitis, or mental health or social conditions that could make it difficult to follow the trial requirements.
• People who are currently taking part in, or have taken part in, another clinical trial involving an experimental treatment or device within the last 30 days.
• People who have HIV infection or a cancer related to HIV.
• People who have an active hepatitis B or hepatitis C infection.
• People who have a known allergy or sensitivity to CPX-351, idarubicin, or cytarabine (the study drugs).
• People who currently have another active cancer, other than certain non-serious skin cancers or early-stage cervical changes — people who finished treatment for a prior cancer, have been cancer-free for more than one year, or whose doctor considers their risk of that cancer returning to be less than 30%, may still be considered.
• People who have signs that leukaemia has spread to the brain or spinal cord.
• People whose heart pumping function (ejection fraction) is below 50%, or whose heart scan results are considered abnormal.
• People who are pregnant or breastfeeding during the expected duration of the trial.

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