Phase 2 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:

• Phase 1 only: Children aged 2 to under 18 years (pediatric group), or adults aged 18 and older (other groups), depending on the cohort.
• Phase 1: People with acute leukemia that has come back or stopped responding to treatment, and who have run out of other available treatment options or cannot receive them.
• Phase 1: People whose acute leukemia has specific genetic changes in the KMT2A, NPM1, NUP98, or NUP214 genes.
• Phase 2 only: Adults aged over 18 years.
• Phase 2 only: People who were originally diagnosed with acute myeloid leukemia (AML) — a specific type of blood cancer — under recognised medical guidelines, and whose disease has come back or stopped responding to treatment.
• Phase 2 only: People whose AML has specific genetic changes in the KMT2A or NPM1 genes.
• Both phases: People whose blood test results before starting the trial show a white blood cell count within an acceptable range, and whose kidneys are working at a sufficient level (specific thresholds differ for adults and children — confirm with trial site).
• Both phases: People who are well enough to carry out basic daily activities, as measured by standard medical scoring tools (confirm exact score requirements with trial site).
• Both phases: Women who could become pregnant must have a negative pregnancy blood test at the start of the trial and within 48 hours before the first treatment dose.
• Both phases: People who agree to follow all required contraception rules during the trial and for 90 days after the last dose (for males) or 6 months after the last dose (for females), and who agree not to donate or freeze eggs or sperm during this period.

Who may not be able to join:

• People with certain specific types of leukemia, including acute promyelocytic leukemia, Down syndrome-associated leukemia, or juvenile myelomonocytic leukemia.
• People who currently have active cancer affecting the brain or spinal cord.
• People who have previously had a solid organ transplant (such as a kidney, liver, or heart transplant).
• People with certain heart rhythm readings outside the acceptable range on an ECG, or who have a family history of a condition called Long QT syndrome (a heart rhythm disorder).
• People who received a bone marrow or stem cell transplant from a donor within 3 months before joining the trial, who show signs of a complication called graft versus host disease, who received a donor immune cell treatment within 1 month before joining, or who currently need immune-suppressing medications (with a limited exception for low-dose steroid use — confirm with trial site).
• People who received certain cancer immunotherapy treatments within 4 weeks before joining the trial, or a drug called blinatumomab within 2 weeks before joining, or other prior cancer treatments within 4 weeks or within 5 half-lives of the drug (whichever is the shorter period).

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