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 signed (or are willing to sign) a written consent form to participate
• People newly diagnosed with a specific type of blood cancer (AML) that tests positive for a protein called CD33 and has a change in a gene called NPM1, as classified by current medical standards
• People aged 18 to 70 years old
• People healthy enough to tolerate intensive chemotherapy, meaning they can carry out basic daily activities, and their liver and kidneys are functioning at an adequate level
• People whose white blood cell count is below a certain level (a medication called hydroxyurea may be used beforehand to help meet this requirement)
• Male participants who are willing to avoid unprotected sex and sperm donation from the time of signing consent until 7 months after the last dose of the study drug
• Women who could become pregnant must have a negative pregnancy test (blood or urine) within 72 hours before starting the study drug

Who may not be able to join:

• People whose AML has a specific genetic change called an activating FLT3 mutation
• People whose AML has come back or has not responded to previous treatment
• People whose AML developed after a prior blood condition called MDS, if that MDS was previously treated with certain chemotherapy drugs
• People with a history of another cancer, unless they have been cancer-free for at least 1 year before starting the study — though certain minor skin cancers, early-stage cervical or breast cancer in situ, or very early-stage incidental prostate cancer findings may be exceptions (confirm with trial site)
• People who have previously been treated with a class of drugs called hypomethylating agents (HMAs) or a drug called venetoclax
• People who have had any previous treatment for AML, other than hydroxyurea
• People who have previously received a cumulative high dose of a class of chemotherapy drugs called anthracyclines (above a set threshold in doxorubicin-equivalent terms)
• People whose AML has spread to the brain or spinal fluid, or whose disease is only outside the bone marrow
• People with a known allergy or sensitivity to any of the study drugs, including venetoclax, azacitidine, cytarabine, daunorubicin, gemtuzumab-ozogamicin, or mitoxantrone, or to inactive ingredients in these preparations
• People known to be living with HIV, or who have a history of active or long-term hepatitis infection, unless test results confirm the infection has fully cleared
• People who are unable to swallow tablets or capsules
• People with a condition that affects how the body absorbs food or medication from the gut
• People with moderate to severe heart disease, unstable heart conditions, or serious irregular heart rhythms requiring medication — though a heart attack more than 6 months before joining may be acceptable (confirm with trial site)
• People with a long-term breathing condition that requires continuous supplemental oxygen
• People with substance use issues, or medical, psychological, or social circumstances that could interfere with participation in the trial
• People currently taking part in another interventional clinical trial
• People who are pregnant or breastfeeding — breastfeeding must be stopped before and during treatment and for at least 3 months after treatment ends
• Women who are able to become pregnant and are unwilling to use highly effective contraception (a hormonal method combined with a barrier method) from the time of signing consent until 7 months after the last study drug dose — unless they meet specific criteria such as being post-menopausal, having had both ovaries removed, having medically confirmed ovarian failure, or whose partner has had a vasectomy (confirm with trial site)
• People with a history of significant liver scarring (cirrhosis), specifically classified as Child-Pugh class B or C
• People who have received a live-virus vaccine within 28 days before starting the study treatment — note that COVID-19 vaccines are not considered live-virus vaccines and are not affected by this rule

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