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.
• People who have been diagnosed with acute myeloid leukemia (AML), confirmed by laboratory testing.
• People whose AML is in remission at the time of screening — either full remission (very low blast cell levels, normal blood counts, and no disease outside the bone marrow) or partial remission (very low blast cell levels and no disease outside the bone marrow, but blood counts not yet fully recovered).
• People whose AML has a specific gene change — either a KMT2A rearrangement (a change in a gene called KMT2A, but not a specific type called partial tandem duplication) or an NPM1 mutation (a change in a gene called NPM1), confirmed by local laboratory testing. The exact timing of when this mutation needs to have been found depends on the individual's treatment history (confirm with trial site).
• People who have received a type of drug called a menin inhibitor before the transplant, as long as their AML did not relapse or worsen while taking it.
• People who are planned to have their very first stem cell transplant from a donor (allogeneic HCT) for this condition.
• People whose transplant will use a standard high-dose or reduced-intensity preparation treatment beforehand.
• People whose stem cell donor matches one of the following categories: a related donor who is at least a 5 out of 6 tissue match; an unrelated donor who is at least a 7 out of 8 tissue match (tested at a detailed level); a related donor who is at least a half-match (3 out of 6); or umbilical cord blood that is at least a 4 out of 6 match (one or two cord blood units may be used).
• People using any standard, non-experimental medication regimen to prevent graft-versus-host disease (a complication of transplants).
• People with a general health and activity level rated 0, 1, or 2 on a standard medical scale (meaning able to carry out most daily activities, with some limitations at most).
• People whose liver and kidney are functioning within acceptable ranges, as measured by standard blood tests.
• People whose heart pumping function is at least 50%, confirmed by a heart scan or ultrasound.
• Women of childbearing potential who have a negative pregnancy test before joining.
• Women of childbearing potential and men who agree to use reliable contraception (or abstinence) throughout the entire treatment period and for 6 months after the last dose of the study drug.
• People who are able to understand the study and are willing to sign a written consent form.

Who may not be able to join:

• People with a history of another cancer, unless they have been cancer-free for at least 2 years and the treating doctor considers the risk of it returning to be low; or the other cancer has been slow-growing with no change in the past 2 years and is considered low risk; or the only other cancer was cervical cancer in situ, or a common type of skin cancer (basal cell or squamous cell carcinoma).
• People with a known active hepatitis B or hepatitis C infection.
• People with current or past heart failure classified as severe (New York Heart Association class 3 or 4), or any history of reduced heart pumping function below 50%.
• People with a current or past history of serious heart rhythm problems, or a condition called long-QT syndrome.
• People with an active, uncontrolled infection.
• People who have difficulty swallowing, impaired gut absorption, slow stomach emptying, or any other condition that would prevent them from taking or absorbing tablets or capsules properly.
• People with high blood pressure that is not controlled (systolic reading above 180 mmHg or diastolic above 100 mmHg).
• People with a specific heart electrical measurement (QTcF interval) of 480 milliseconds or more, or other factors that raise the risk of heart rhythm problems (such as low potassium levels or a family history of long-QT syndrome).
• People with any other ongoing medical condition that is not well controlled and would make it difficult to follow the study requirements.
• People who are pregnant or breastfeeding.

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