Phase 1 Leukaemia Trial, Recruiting

Written by an AI model from the 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 aged 18 or older who have signed a consent form before taking part in the study
• People who have been diagnosed with acute myeloid leukemia (AML) that has come back or has not responded to treatment, confirmed by laboratory testing using 2022 World Health Organization (WHO) standards
• People whose AML did not respond to at least 2 cycles of intensive or standard treatment, meaning cancer cells (blasts) still make up 5% or more of the bone marrow, or have reappeared in the blood
• People whose AML has a specific genetic change called a FLT3 mutation (either the ITD or TKD type)
• People whose AML also has one of the following genetic features: an NPM1 mutation, an MLL gene rearrangement, or another genetic change known to cause overexpression of HOXA-MEIS1 (such as NUP98, UBTF-TD, MLL-PTD, or others supported by published research)
• People who are already taking one of the following antifungal medications — itraconazole, ketoconazole, posaconazole, or voriconazole — for at least 24 hours before joining, and who will continue taking one of these throughout the study
• People who, in the treating doctor's assessment, are not suitable for immediate intensive chemotherapy, based on age, other health conditions, or standard practice
• People who have a general health/activity level rated 0, 1, or 2 on a standard medical scale (meaning they are fully active, have minor limitations, or are up and about more than half the day)
• People whose liver function test results (AST and ALT) are within an acceptable range (no more than 3 times the upper limit of normal)
• People whose bilirubin level (a liver marker) is within an acceptable range (no more than 1.5 times the upper limit of normal), with an exception for a harmless inherited condition called Gilbert syndrome
• People whose kidneys are functioning adequately, based on a standard calculation of kidney filtration rate (at least 60 mL/min/1.73m²)
• People whose heart is pumping adequately, with a heart function measurement (ejection fraction) of at least 50%, confirmed by a heart scan
• People who are able to communicate with the study team and follow the study procedures
• People of childbearing potential who have a negative pregnancy test at the start of the study and again on the first day of treatment
• People who could father a child and are sexually active with someone who could become pregnant must agree to either abstain from sex or ensure their partner uses two forms of contraception from the screening visit until 90 days after the last dose, and must not donate sperm during this period
• People who are able to swallow oral medication
• People whose side effects from any previous treatment have largely resolved (to a low or mild level) before joining, with the exception of mild nerve-related symptoms or hair loss up to a moderate level
• People who have waited the required amount of time since their last treatment before joining, including:
  • At least 60 days since total body radiation or major pelvic radiation, or at least 14 days since minor localised radiation
  • At least 60 days since a stem cell transplant, or at least 4 weeks since a donor white blood cell infusion
  • At least 42 days since immunotherapy such as cancer vaccines or checkpoint inhibitors, or at least 21 days since CAR-T or similar cell therapy
  • At least 14 days, or 5 half-lives (whichever is shorter), since most other anti-leukaemia treatments (with some exceptions for rapidly worsening disease or certain medications like hydroxyurea, as determined by the treating doctor)
  • At least 7 days since short-acting blood cell growth factor therapy, or 14 days since long-acting versions
  • At least 90 days, or 5 half-lives (whichever is shorter), since treatment with a biologic cancer medicine (such as a monoclonal antibody)
  • At least 7 days since steroid treatment, unless taking a very low maintenance dose

Who may not be able to join:

• People diagnosed with a specific subtype of leukaemia called acute promyelocytic leukaemia
• People whose AML has spread outside the bone marrow to form tumours in other tissues (extra-medullary AML or myeloid sarcoma), as classified under 2022 WHO standards
• People where there is a suspicion that leukaemia has spread to the fluid around the brain or spinal cord, unless it has been cleared or is being actively treated
• People with a history of another cancer, unless that cancer has been fully treated and no ongoing cancer treatment (chemotherapy, radiation, or surgery) is needed during the study — people on hormone-based maintenance therapy may still be considered, but people whose cancer was caused by a previous cancer treatment are not eligible
• People with a known allergic reaction to gilteritinib or SNDX-5613 (note: having previously taken gilteritinib without an allergy does not exclude someone)
• People with HIV who do not have a fully suppressed (undetectable) viral load on anti-retroviral treatment within the past 6 months
• People with active hepatitis B (HBV) infection without an undetectable viral load on appropriate treatment
• People with a history of hepatitis C (HCV) who have not been successfully treated and cured, or who are currently being treated but do not yet have an undetectable viral load
• People whose heart's electrical activity shows a prolonged QTcF interval (greater than 450 milliseconds) on a heart tracing test at screening
• People with serious heart rhythm problems, such as ventricular tachycardia, ventricular fibrillation, or a condition called Torsades de pointes
• People with poorly controlled heart conditions, including unstable chest pain, serious irregular heartbeat, a heart attack within the past 2 months, or severe heart failure (classified as Class III or IV)
• People with an active infection that is not yet under control
• People with a psychiatric condition that prevents them from fully understanding and consenting to the study
• People who are pregnant or breastfeeding at the time of enrolment
• People who have a condition affecting how their body absorbs food or medication through the digestive system, making it impossible to take oral treatment
• People with a history of serious conditions affecting the heart, hormones, liver, immune system, metabolism, nervous system, lungs, kidneys, or any other condition that, in the treating doctor's opinion, could negatively affect their participation or the reliability of the study results

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