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 newly diagnosed with a specific type of acute myeloid leukaemia (AML) involving a change in a gene called NPM1, or a rearrangement of a gene called KMT2A, confirmed by the 2022 International Consensus Classification (confirm with trial site for exact genetic details)
• People whose genetic diagnosis has been confirmed by one of the designated central laboratories for this trial
• People aged 18 or older (there is no upper age limit)
• People whose doctor has determined they are not suitable for intensive chemotherapy — this may apply to people aged 75 or older, or to people aged 18–74 who have certain health conditions such as heart problems, reduced lung function, reduced kidney function, liver problems, or a general health/activity level that makes intensive treatment unsuitable
• People whose doctor estimates they have a life expectancy of at least 12 weeks
• People whose white blood cell count is below a certain level before starting the trial (a medication called hydroxyurea may be used beforehand to bring this count down if needed)
• People with kidney function above a minimum threshold, as measured by specific blood or urine tests
• People with liver function within an acceptable range, as measured by specific blood tests
• Women who are either post-menopausal, have had surgery that means they cannot become pregnant, or who agree to use highly effective contraception plus a barrier method during the trial and for 6 months after the last dose, and who test negative for pregnancy at the start
• Women who agree not to breastfeed or donate eggs during the trial and for 6 months after the last dose
• Men who agree to use a condom during any sexual contact with a woman who could become pregnant, and whose female partners who could become pregnant agree to use highly effective contraception — this applies during the trial and for 6 months after the last dose
• Men who agree not to donate sperm during the trial and for 6 months after the last dose
• People who are able to understand the trial information and are willing to sign a consent form

Who may not be able to join:

• People who have previously received treatment for AML (prior use of hydroxyurea to control white blood cell counts is allowed; prior treatment with certain medications for a related blood condition called MDS-EB is not allowed)
• People with a specific subtype of leukaemia called acute promyelocytic leukaemia (APL)
• People whose AML is linked to a gene change called BCR-ABL1, or whose chronic myeloid leukaemia (CML) has progressed to a blast crisis
• People who have had significant heart problems in the 3 months before the trial, including severe heart failure, a heart attack, unstable chest pain, serious heart rhythm problems, or an inherited heart condition affecting the heart's electrical activity, or whose heart electrical reading (ECG) is above a certain level
• People with a severe lung condition affecting breathing
• People who have had a stroke or bleeding in the brain within the 6 months before joining the trial
• People with signs or a confirmed diagnosis of leukaemia affecting the brain or spinal fluid
• People with an active, uncontrolled infection (including hepatitis B, hepatitis C, or HIV) that has not been brought under control before the first dose — certain controlled infections on appropriate treatment may still be eligible (confirm with trial site); people with COVID-19 may only be considered if they have no symptoms and have had two negative PCR tests
• People with life-threatening complications of leukaemia such as uncontrolled bleeding or a serious clotting disorder
• People who have difficulty swallowing or absorbing medications taken by mouth
• People who currently have another active cancer — some exceptions apply for certain low-risk skin cancers and some early-stage cancers (confirm with trial site)
• People who have received a live vaccine within 30 days before joining the trial
• People with a severe neurological or psychiatric condition that affects their ability to give informed consent
• People with a known allergy or sensitivity to any of the medications used in the trial
• People currently participating in another clinical trial involving cancer treatments or experimental drugs
• People taking a blood-thinning medication called Dabigatran, unless they are able to switch to a different medication at least 5 half-lives before starting the trial; people taking certain other medications that interact with the trial drugs may need to be monitored or switched (confirm with trial site)
• People taking strong medications that affect a liver enzyme called CYP3A4, unless they are able to switch to a different medication at least 5 half-lives before starting the trial
• Women who are pregnant or breastfeeding, or who plan to become pregnant during the trial
• People who were previously screened and enrolled into this same trial but were later found to be ineligible — re-entry into the trial at a later date is not permitted

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