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 aged 18 or older who provide written consent before any study procedures begin.
• People diagnosed with acute myeloid leukaemia (AML) whose disease has returned or did not respond to their first round of treatment (with or without a stem cell transplant).
• People in Group 1 who have a specific gene change called FLT3-ITD or FLT3-TKD, confirmed by a central laboratory test.
• People in Group 2 who have a documented gene change in one of the following genes: SF3B1, SRSF2, U2AF1, or ZRSR2, confirmed by a local laboratory.
• People in Group 1 who previously received a medication called gilteritinib but whose disease did not stop progressing, or who were not considered suitable for gilteritinib by their doctor, or who chose not to take gilteritinib for personal or social reasons.
• People whose doctor estimates they have a life expectancy of at least 3 months.
• People with a general health and activity level rated at 2 or below on a standard medical scale (meaning they are able to care for themselves, even if unable to do physical work).
• People whose liver enzyme levels (AST and ALT) are within an acceptable range based on blood tests.
• People whose bilirubin (a substance processed by the liver) is within an acceptable range, unless a condition called Gilbert's disease is the cause of any elevation.
• People whose kidneys are functioning at an acceptable level based on a standard calculation from blood tests.
• Female participants who are not able to become pregnant (due to surgical sterilisation at least 6 weeks before screening, or being post-menopausal for at least 12 months confirmed by hormone testing).
• Female participants who could become pregnant, provided they have a negative pregnancy test at screening and again at clinic admission, agree not to try to become pregnant or donate eggs for at least 45 days after the last dose of study drug, and agree to use adequate contraception (a condom used by a male partner plus a highly effective method) from screening until at least 45 days after the last dose, unless in an exclusively same-sex relationship or committed to abstinence.
• Male participants and their female partners who could become pregnant must agree to use two forms of contraception (at least one being a barrier method) from screening until 45 days after the last dose, and male participants must agree not to donate sperm during this period.

Who may not be able to join:

• People whose AML exists only as a tumour outside the blood or bone marrow (called isolated myeloid sarcoma), without involvement of the blood or marrow.
• People diagnosed with a specific subtype of leukaemia called acute promyelocytic leukaemia (also known as FAB M3).
• People whose AML has spread to the brain or spinal cord (central nervous system).
• People showing urgent clinical signs of a dangerous condition where too many leukaemia cells are blocking blood flow, requiring immediate treatment.
• People with a known active HIV, hepatitis B, or hepatitis C infection. People with a past positive test for hepatitis B or C will need a negative PCR test (a test that looks for the actual virus) before being considered.
• People with a serious clotting disorder that is causing uncontrollable bleeding or signs of dangerous blood clots.
• People who have received an experimental treatment (not yet approved by health authorities) within a certain period before the study start — generally within 5 half-lives of that treatment, or at least one week if the half-life is unknown (confirm with trial site).
• People who have received cancer-directed medication within 5 half-lives, or radiation therapy within one week before starting the study — except for hydroxyurea, which is allowed to help manage white blood cell counts.
• People who are pregnant or breastfeeding.
• People whose personal circumstances, health conditions, or other factors would make it difficult to safely participate, follow the study plan, or would make it hard to interpret the study results.
• People with serious uncontrolled heart conditions, including severe heart failure (rated Class III or IV on a standard heart failure scale), unstable chest pain, dangerous heart rhythm problems, or a heart attack with remaining heart problems within the 6 months before joining.
• People with an infection that is not under control — people with infections that are being managed may still be considered, in the opinion of the treating doctor.

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