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 21 years or younger.
• People diagnosed with acute myeloid leukemia (AML) or a related type of acute leukemia (called acute leukemia of ambiguous lineage) that has either not responded to at least two rounds of chemotherapy, or has come back after treatment — with this confirmed through specific bone marrow or blood tests showing leukemia cells are still present or increasing.
• At least 60 days must have passed since the person had a stem cell transplant (if applicable).
• People who have had a previous stem cell transplant from a donor must show no signs of a complication called graft versus host disease (where donor cells attack the body), and must have been off certain anti-rejection medications for at least 28 days (a small dose of a steroid medication may still be allowed — confirm with trial site).
• At least 14 days must have passed since finishing most types of chemotherapy or a drug called gemtuzumab ozogamicin, and any side effects from that treatment must have mostly resolved.
• At least 24 hours must have passed since finishing any lower-intensity treatments used to manage the leukemia.
• The person must have a performance score of at least 50 on a standard health and functioning scale used for their age group — meaning they are able to carry out some daily activities (confirm with trial site).
• The number of white blood cells in the blood must be at or below a certain level (this can be brought down with medication before joining if needed).
• Liver function test results must be within acceptable ranges for the person's age.
• The heart must be pumping blood adequately, confirmed by an ultrasound of the heart.
• Kidney function must be at or above a certain level, based on a blood test.

Who may not be able to join:

• People who are currently receiving, or planning to receive, any other cancer treatment at the same time (such as chemotherapy, radiation, or immunotherapy).
• People with Down syndrome.
• People diagnosed with specific leukemia subtypes called Acute Promyelocytic Leukemia (APL) or Juvenile Myelomonocytic Leukemia (JMML).
• People with a condition called Bone Marrow Failure Syndrome.
• People who are pregnant, or who are not willing to use an effective method of contraception during the trial.
• Women who are breastfeeding and do not agree to stop breastfeeding during the trial.
• Cases where a parent or legal guardian is unable or unwilling to give written consent for the person to participate.
• People with an active, uncontrolled infection (such as a fungal, bacterial, or viral infection).

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