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:

• People who have been newly diagnosed with acute myeloid leukemia (AML) — a type of blood cancer — according to 2022 medical classification standards, and have not previously received treatment for it, except for a medication called hydroxyurea. Brief prior treatment with ATRA (for less than 5 days) is also acceptable. People whose AML developed from a prior blood disorder may have received treatment for that earlier condition, as long as it did not include a bone marrow transplant from a donor.
• People aged 18 to 74 years old.
• People whose general physical functioning falls within a certain range on a standard medical scale (ECOG 0–2), meaning they are able to carry out at least some daily activities (confirm with trial site).
• People whose leukemia cells carry specific gene changes called FLT3-ITD and/or TKD mutations, as well as an NPM1 mutation, found in bone marrow or blood samples.
• For the dose-escalation part of the trial only: People whose leukemia also has certain additional high-risk genetic features, such as specific chromosomal rearrangements, deletions, or mutations in genes including ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, ZRSR2, TP53, or DNMT3A (confirm with trial site for the full list).
• People whose heart is pumping at 50% or above efficiency, as measured by a heart scan (MUGA or echocardiogram).
• People whose kidneys are functioning well enough, based on a calculated score of 60 mL/min or higher (confirm with trial site).
• People whose liver is functioning within acceptable ranges, based on blood test results for liver enzymes and bilirubin — exceptions may apply if abnormal results are caused by the leukemia itself, or if the person has a condition called Gilbert's Syndrome (confirm with trial site).
• People who have recovered from any side effects of prior medications (such as hydroxyurea) to a mild level or better.
• People whom their treating doctor considers fit enough to receive intensive chemotherapy using two drugs called cytarabine and daunorubicin.
• Male participants who agree to avoid unprotected sex and sperm donation from the start of the trial until 90 days after the last dose.
• People who can become pregnant must have a negative pregnancy test result within 7 days before starting the trial.
• People who are able to understand the study and are willing to sign a written consent form.
• For the consolidation treatment phase: People who have responded to the initial treatment (with less than 5% cancer cells remaining in bone marrow and blood counts recovering to certain levels), are sufficiently well physically, and have recovered from side effects to a mild level or better.

Who may not be able to join:

• People diagnosed with certain specific types of AML — acute promyelocytic leukemia, or AML with chromosomal changes called inversion 16 or t(8;21) (confirm with trial site).
• People whose AML has spread to the central nervous system (brain and spinal cord).
• People who have taken a strong CYP3A4-inducing medication (a type of drug that affects how other medicines are processed by the body) within 7 days before starting the trial (confirm with trial site for the list of affected drugs).
• People taking certain strong CYP3A4-inhibiting medications, with exceptions for specific antifungal medications — in those cases, the dose of one trial drug may need to be adjusted (confirm with trial site).
• People with a particular measurement of heart electrical activity (QTcF interval) greater than 450 milliseconds, which may indicate a heart rhythm concern.
• People who have tested positive for HIV, due to possible interactions between HIV medications and the trial drugs. HIV testing is not required to join the trial.
• People known to be positive for hepatitis B or C, unless their virus levels are undetectable within the past 3 months. People with evidence of prior hepatitis B vaccination may still be eligible (confirm with trial site).
• People who have consumed grapefruit, grapefruit products, Seville oranges (including marmalade made with Seville oranges), or star fruit within 3 days before starting the trial.
• People with heart disease that causes symptoms during ordinary everyday activity or at rest, based on a standard heart disease classification scale (New York Heart Association Class 2 or above).
• People with a significant history of serious kidney, neurological, psychiatric, hormonal, metabolic, immune system, liver, or cardiovascular conditions that the study doctor believes could be affected by participation.
• People who require continuous oxygen use due to a chronic breathing condition.
• People who have difficulty absorbing medications taken by mouth due to a digestive condition.
• People with other significant, uncontrolled medical conditions, including serious uncontrolled infections.
• People with a history of other cancers, with some exceptions: certain early-stage or skin cancers that were treated, cancers that were completely surgically removed with the intent to cure, or prior cancers that have been in full remission for at least two years after completing treatment.
• People who have received chemotherapy, immunotherapy, or any other investigational treatment within one month of enrolling in the trial.
• People who have previously been treated with a type of drug called a menin inhibitor.

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