Phase 3 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 14 to 75 years old.
• People who have been newly diagnosed and have had detailed genetic testing of their bone marrow before a stem cell transplant.
• People whose genetic testing showed one of the following patterns: (ARM 1) a TP53 gene mutation, or certain other gene mutations linked to a type of leukaemia called AML-MR; (ARM 2) a FLT3-ITD gene mutation, with or without an NPM1 mutation, but without TP53 or AML-MR mutations; (ARM 3) a KIT gene mutation at specific locations, without TP53, AML-MR, or FLT3-ITD mutations; or (ARM 4) a diagnosis of MDS or AML at intermediate or higher risk, without any of the gene mutations listed in ARMs 1, 2, or 3.
• People who have received their first ever allogeneic stem cell transplant (a transplant using donor cells) within 30 to 60 days before joining, and whose test results show that their blood cells are fully from the donor.
• People whose disease is in complete remission before starting maintenance therapy, with no detectable signs of leukaemia on a specialised bone marrow test (MRD negative).
• People who have no active infection and no acute graft-versus-host disease (a complication where donated cells attack the body) that requires systemic treatment.
• People whose organ function and blood test results within 7 days before starting treatment meet all of the following: liver enzymes (AST and ALT) within 3 times the normal upper limit; bilirubin within 1.5 times the normal upper limit (or within 3 times the upper limit for people with a known condition called Gilbert's syndrome); haemoglobin of at least 70 g/L without a recent blood transfusion; neutrophil count of at least 0.8 × 10⁹/L without recent use of certain growth factor medications; platelet count of at least 20 × 10⁹/L without a recent platelet transfusion; kidney function within acceptable limits; normal blood clotting results; and heart pumping function (LVEF) of at least 45%.
• Women who could become pregnant must have a negative pregnancy blood test within 7 days before the first dose.
• People who are willing to use highly effective contraception from the time of signing consent until 180 days after the last dose — this applies to women who could become pregnant and to men whose partners could become pregnant.
• People who are willing to sign a consent form, follow the study requirements, and attend follow-up visits.

Who may not be able to join:

• People whose bone marrow or blood tests show that signs of disease have returned (MRD has changed from negative to positive).
• People who have acute or chronic graft-versus-host disease, or an active infection that requires systemic (whole-body) immunosuppressive therapy before starting maintenance treatment.
• People with significant active heart conditions, such as uncontrolled irregular heartbeat, uncontrolled high blood pressure, heart failure, a serious heart condition classified as Grade 3 or 4 by standard medical criteria, or a heart attack within the 6 months before screening.
• People with other serious medical conditions that could affect their ability to take part, such as uncontrolled diabetes or active autoimmune disease.
• People known to have HIV, or who have hepatitis B or hepatitis C that is not being adequately controlled with medication.
• People with neurological (brain or nerve) or psychiatric (mental health) disorders.
• People who are unable to understand or follow the study protocol, or who are unable to sign a consent form.
• People whom the trial doctor does not consider suitable for the study for any other reason.

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