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 diagnosed with AML (a type of blood cancer) who have measurable disease in the bone marrow, and whose disease has come back after treatment, did not go into remission after it came back, or did not go into remission after at least two attempts to treat it from the start.
• People whose AML developed as a result of previous cancer treatment (called treatment-related AML) may be eligible, including those newly diagnosed with this type — a relapse is not required.
• People whose leukemia started as a different type (ALL or unspecified acute leukemia) and has since changed to AML, provided the disease has relapsed or has not responded to treatment.
• People with Down syndrome.
• People who are well enough to carry out some daily activities, as measured by standard performance scales used by doctors (confirm with trial site).
• People who have fully recovered from the side effects of any previous chemotherapy, immunotherapy, or radiation treatment before joining.
• People who have had a bone marrow or stem cell transplant may be eligible, provided it has been at least 90 days since the transplant, there is no sign of a complication called graft-versus-host disease (GVHD), and GVHD treatment has stopped.
• People who have waited the required amount of time after previous treatments, including certain minimum waiting periods after chemotherapy, growth factor injections, biological therapies, antibody treatments, immunotherapy (such as CAR-T cells), and radiation — the required waiting time varies depending on the treatment type (confirm with trial site for specific timeframes).
• People whose kidneys and liver are functioning well enough, as shown by standard blood tests — with some exceptions possible if the liver is affected by the leukemia itself (confirm with trial site).
• People whose heart is functioning well enough, as shown by standard heart tests.
• People who are able to take antifungal preventive medication for the duration of treatment.
• Female patients of childbearing potential who have a negative pregnancy test within two weeks before joining.
• Male and female patients of childbearing potential who agree to use an effective method of contraception during the study and for at least six months after treatment ends.
• Female patients who are breastfeeding must agree to stop breastfeeding while on the study.
• People (or their parents or legal guardians) who are able to understand the study and sign a written consent form — age-appropriate agreement will also be sought from younger patients, and language support will be provided where possible.

Who may not be able to join:

• People with a known allergy to any of the drugs used in this trial.
• People who currently have an active fungal, bacterial, viral, or other infection that is not improving with appropriate treatment, or who have required medication to support blood pressure, or have had positive blood cultures within the past 48 hours.
• People who have had a positive fungal infection test within the 30 days before joining, or who have evidence of a fungal infection that has spread through the body.
• People for whom other chemotherapy, radiation, or immunotherapy not part of this trial is planned during the study period.
• People with serious other illnesses, mental health conditions, or personal or social circumstances that could affect their safety, their ability to follow the study requirements, or the reliability of the results.
• People with certain rare genetic conditions that affect how the body repairs DNA, such as Fanconi anemia or Bloom syndrome.

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