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 who are male or female and at least 12 years old.
• People who weigh at least 40 kilograms (about 88 pounds).
• People who have a confirmed diagnosis of AML (acute myeloid leukemia), ALL (acute lymphoblastic leukemia), or MPAL (mixed phenotype acute leukemia), and whose disease has come back a second time or more, or whose disease did not respond to at least one previous treatment attempt.
• People who are able to swallow oral (by mouth) medication.
• People who have a general health and activity level rated at a certain minimum standard — specifically, an ECOG score of 0, 1, or 2, or a Lansky/Karnofsky score of 50 or higher (confirm with trial site if unsure what score applies).
• People whose blood cell counts, kidney function, and liver function meet certain minimum levels at the screening stage (confirm specific values with trial site).
• Women who are able to become pregnant must not be currently pregnant or breastfeeding, and must have a negative pregnancy test at the start of the trial and at the beginning of the first four treatment cycles.
• People who are willing and able to use reliable contraception (two methods at the same time) during the trial and for four months after the last dose — this applies to both women who could become pregnant and to men.
• People who are able to give written informed consent; for those under 18, a parent or guardian must also provide consent.
• People whose white blood cell count is below 25,000/mm³ at screening, or whose count can be brought below that level with a short course of a medication called hydroxyurea before starting the trial drug.
• For a specific group in this trial focused on a gene change called FLT3 ITD: people in this group must have previously received at least one FLT3 inhibitor treatment.

Who may not be able to join:

• People who have a type of leukemia called acute promyelocytic leukemia (also known as AML M3).
• People who have leukemia that is known to be active in the central nervous system (brain and spinal cord).
• People who have a medical or surgical condition — active or ongoing — that could affect how the trial drug is absorbed or processed by the body, or that could put them at risk.
• People who have had another type of cancer that required systemic (whole-body) treatment within the last two years, or that may interfere with the trial, unless it was a treated skin cancer (non-melanoma), a localised pre-cancerous condition, or cervical changes that have been fully treated.
• People who have received radioactive (radionuclide) treatment within six weeks before the first trial dose.
• People who have received cancer treatments such as chemotherapy within 14 days before starting the trial drug (or within six weeks for certain specific chemotherapy types).
• People who have not yet fully recovered from the side effects of previous cancer treatments (hair loss is an exception).
• People who have active, clinically significant graft-versus-host disease (GvHD) — a complication that can occur after a stem cell or bone marrow transplant.
• People who have taken a group of medications called calcineurin inhibitors within four weeks of starting the trial.
• People who are known to have HIV.
• People who have taken a small molecule kinase inhibitor or any other investigational (experimental) drug within 28 days — or five half-lives of that drug, whichever is longer — before starting the trial drug.
• People who have an active hepatitis B or C infection.
• People who have an active infection that is not under control.
• People who have Type 1 Diabetes, or who are considered at high risk for Type 1 Diabetes — defined as having one close family member (parent, sibling, or child) with Type 1 Diabetes and a blood sugar marker (A1C) above 6.5%, or having two or more such close family members with Type 1 Diabetes.
• People who have a known or suspected history of a retinal condition called retinitis pigmentosa, or a known or suspected family history of it.
• People who need to take blood-thinning or anti-clotting medications at treatment doses (such as warfarin, clopidogrel, or similar drugs) — note that low-dose aspirin, very low-dose warfarin, and preventive low-molecular-weight heparin are permitted.
• People who have moderate to severe heart failure (classified as NYHA class 3 or 4), unless a recent heart scan shows the heart is still pumping adequately (left ventricular ejection fraction of 45% or higher).
• People who have a specific heart rhythm measurement called QTcF that is greater than 480 milliseconds on an ECG.
• People who have had major surgery within four weeks of the first trial dose.
• People who are unwilling or unable to follow the trial protocol or work cooperatively with the trial team.

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