Phase 1 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 to 75 years old at the time of AML (acute myeloid leukemia) diagnosis who have not yet received treatment for their AML, and whose AML has certain specific genetic features — including a mutation in a gene called NPM1 (without certain other mutations), a rearrangement in a gene called MLL (also known as KMT2A), or a change in a gene called NUP98.
• During the dose escalation phase, people with NPM1-mutated AML must also have at least one high-risk feature, such as being aged 60 or older, having certain high-risk genetic markers, or having AML that developed from a prior blood condition or prior cancer treatment.
• During the dose expansion phase, people with NPM1-mutated AML do not need to have high-risk features to be considered.
• People whose AML is considered suitable for intensive chemotherapy treatment.
• People whose AML tests positive for a marker called CD33.
• People who are physically well enough to carry out normal daily activities, rated on a standard scale — generally a score of 2 or below, or a score of 0–1 for those over 65 years old.
• People whose liver is functioning well enough, based on blood test results within standard ranges (or a slightly higher range for those with a condition called Gilbert's syndrome).
• People whose kidneys are functioning at an adequate level, based on a standard measurement of kidney filtration.
• People living with HIV, provided they are on effective treatment and their virus levels have been undetectable within the past 6 months.
• People with a history of hepatitis B, provided the virus is undetectable while on appropriate treatment.
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently being treated and have undetectable virus levels.
• People who have had or currently have another type of cancer, as long as that cancer or its treatment is unlikely to interfere with the safety or results of this trial (confirm with trial site).
• People with known heart disease or a history of treatment with medications that can affect the heart, provided a standard heart function assessment rates them at class 2B or better.
• People whose heart pumping function (ejection fraction) is at least 50%, or at least 45% if there are no signs of heart failure or other heart symptoms, as measured by a heart scan.
• People whose white blood cell count is below a certain level before starting the trial; medication to lower white blood cell counts beforehand may be permitted, but must be stopped within 24 hours of starting the trial treatment.
• People who agree to use two forms of contraception during and for a set period after treatment — 120 days after the last dose for women who could become pregnant, and 180 days after the last dose for men who could father a child; men must also agree not to donate sperm during this time.
• People who have had no prior AML treatment other than a medication called hydroxyurea, or chemotherapy given directly into the spinal fluid for nervous system protection or treatment.
• People who are willing and able to provide written informed consent, or who have a legally authorised representative who can do so on their behalf.

Who may not be able to join:

• People who have previously had a significant allergic reaction to medications chemically similar to the study drug SNDX-5613, daunorubicin, or cytarabine.
• People with other serious, uncontrolled illnesses or conditions that would make participation in this trial unsafe.
• People who have taken certain medications that strongly or moderately affect how the body processes drugs (known as CYP3A4 inhibitors or strong CYP3A4 inducers) within the 7 days before enrolling — with an exception for certain antifungal medications.
• People who are pregnant, as the study drug may harm an unborn baby.
• People who are breastfeeding, as the study drug may pose a risk to nursing infants.
• People whose AML exists only as a tumour outside the blood or bone marrow (called isolated myeloid sarcoma), rather than involving the blood or bone marrow.
• People diagnosed with a specific subtype of leukaemia called acute promyelocytic leukaemia (APL, also known as FAB M3).
• People with active, untreated AML that has spread to the central nervous system (the brain and spinal cord).
• People with an uncontrolled blood clotting disorder called disseminated intravascular coagulopathy (DIC) that is causing active bleeding or signs of clotting.
• People with a specific heart rhythm measurement (QTcF) at or above 450 milliseconds at screening, or with a personal or family history of a condition called long QT syndrome — although people with certain types of heart conduction changes or a pacemaker who have no symptoms may still be considered if cleared by a heart specialist.
• People who would exceed a lifetime safe limit of a class of chemotherapy drugs called anthracyclines if they received the full amount allowed in this trial.
• People with digestive system conditions affecting the upper stomach or bowel that could interfere with absorbing oral medication (for example, gastric bypass surgery or gastroparesis).
• People with advanced liver scarring (cirrhosis) rated at Child-Pugh class B or C.
• People with Down Syndrome, due to a higher risk of certain side effects associated with the treatment used in this trial.
• People with a condition called myelodysplastic syndrome (MDS) who have previously been treated with intensive chemotherapy similar to the standard "7+3" regimen.

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