Phase 3 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 formally diagnosed with Acute Myeloid Leukaemia (AML) confirmed by laboratory testing, following recognised international standards for AML diagnosis.
• People whose AML has come back after treatment (relapsed) or did not respond to treatment (refractory), and who have only received one previous course of treatment for AML.
• People aged between 18 and 80 years old at the time of signing the consent form.
• People who have not received chemotherapy, radiation, or major surgery in the 2 weeks before starting the trial, or who have fully recovered from the side effects of any such treatment.
• People who have not taken part in any other experimental treatment trial within the 4 weeks before starting the trial.
• People whose general physical ability and daily functioning falls within a certain range, as measured by a standard medical scale (ECOG score of 0, 1, or 2 — meaning people who are fully active or able to carry out light activity) (confirm with trial site).
• People whose life expectancy at the time of screening is greater than six weeks.
• People whose liver and kidney function blood test results fall within acceptable ranges at screening (confirm specific values with trial site).
• People who are able to understand and sign the consent form and are able to follow the trial requirements.
• Women who could become pregnant must have a negative pregnancy blood test within 72 hours before the first trial treatment.
• Women who could become pregnant must agree not to donate eggs and to use a highly effective form of contraception from the time of signing the consent form until 6 months after the last trial treatment.
• Men whose partners could become pregnant must agree not to donate sperm and to use a highly effective form of contraception from the time of signing the consent form until 6 months after the last trial treatment.

Who may not be able to join:

• People who have ever been diagnosed with a specific subtype of leukaemia called Acute Promyelocytic Leukaemia (APL), or a condition called MDS/AML (confirm with trial site).
• People who have previously received radiation therapy to the chest area (mediastinal radiotherapy).
• People whose leukaemia has spread to the brain or spinal cord (central nervous system).
• People with certain heart problems, including reduced heart pumping function, heart valve disease, severe uncontrolled high blood pressure, uncontrolled irregular heartbeat, a heart attack in the past 6 months, unstable chest pain, symptomatic heart failure, a specific heart failure classification of 3 or 4, an abnormal heart electrical reading (QTc interval above 480 msec), a history of certain heart rhythm risk factors, or those taking certain medications known to affect heart rhythm — unless the treating doctor determines the medication is essential and can be safely managed.
• People with serious ongoing health conditions such as active infection, chronic lung disease, HIV infection, or active hepatitis B or C infection with ongoing symptoms, or mental health or personal circumstances that would make it difficult to follow the trial requirements.
• People who have mouth sores or inflammation (mucositis/stomatitis) at the time of screening, or who have previously experienced severe mouth sores from prior treatment.
• People whom the treating doctor considers to be at unacceptable risk from participating in the trial.
• People who have previously been treated with a medication called L-asparaginase.
• People who are pregnant or breastfeeding.
• People with a known allergy to anthracyclines, cytarabine, or any ingredients in the trial medications, or to contrast dyes used in certain heart scans required by the trial.
• People who have previously received a total cumulative dose of anthracycline-type chemotherapy above a certain level (more than 300 mg/m² in daunorubicin equivalent dose) (confirm with trial site).
• People whose AML has relapsed or is refractory and who also have a specific gene change called a FLT3 mutation — unless the trial site is located in a country where the standard treatment for this mutation (gilteritinib) is not available.

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