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:

• People who are male or female, aged 12 years or older, and weigh at least 35 kg.
• People who have been diagnosed with acute myeloid leukemia, acute lymphoblastic leukemia, or a related type of acute leukemia, as classified by the World Health Organization (WHO 2022) guidelines.
• People whose leukemia is classified as intermediate or high risk according to a standard medical risk scoring system called ELN.
• People whose leukemia involves one of these specific genetic changes: a mutation in the NPM1 gene (without certain other co-occurring mutations), a rearrangement or change involving the KMT2A gene, a rearrangement involving the NUP98 gene, or other genetic changes that depend on a pathway involving menin and KMT2A (confirm with trial site).
• People who have received a stem cell transplant from a donor between 30 and 180 days before starting the study treatment.
• People whose blood counts have recovered after transplant, with white blood cell and platelet levels meeting specific thresholds, without needing recent blood transfusions or certain blood-stimulating medications.
• People who have achieved a complete remission of their leukemia after their first donor stem cell transplant, confirmed by a bone marrow test within 14 days before joining the study.
• People who have no leukemia present outside the bone marrow.
• People with a general health and activity level rated 0 to 2 on a standard medical scale (meaning able to carry out normal daily activities, with at most some limitations).
• People whose heart, liver, kidneys, and other major organs are functioning adequately.
• People who have provided written agreement to take part in the trial, including a guardian's consent for those aged 12 to 17 years.

Who may not be able to join:

• People who have an active infection that is not under control.
• People who have active viral infections, including certain viruses such as CMV, EBV, adenovirus, or Human Parvovirus B19, detected at levels above defined thresholds.
• People with active hepatitis B, hepatitis C, or HIV infection.
• People with certain heart conditions, including an inherited heart rhythm disorder called long QT syndrome, or moderate to severe heart failure.
• People experiencing significant graft-versus-host disease (a complication of transplant where donor cells affect the body) that requires systemic treatment — specifically, grade 2 or higher acute graft-versus-host disease, or grade 3 or higher chronic graft-versus-host disease.
• People who have already received other maintenance treatments after transplant, such as certain targeted drugs, chemotherapy, or donor immune cell infusions.
• People with a history of another cancer that required systemic treatment, unless it has been in stable remission without ongoing maintenance therapy.
• People with a digestive condition that may interfere with swallowing or absorbing oral medication, such as severe swallowing difficulties, stomach-emptying problems, uncontrolled chronic diarrhea, or gut graft-versus-host disease.
• People who are pregnant or breastfeeding.
• People who have had a known allergic reaction to the study drug BN104.

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