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 18 years of age or older at the time of joining the trial
• People who have been diagnosed with acute myeloid leukemia, mixed phenotype leukemia (in remission, with or without traces of remaining disease), or a bone marrow disorder called myelodysplastic syndrome (MDS) that meets specific criteria for a stem cell transplant, with less than 10% abnormal cells in the bone marrow
• People who are planned to receive one of two specific lower-intensity pre-transplant treatment regimens (the trial site will determine which one applies)
• People who have a matching stem cell donor (related or unrelated) with a full 8 out of 8 match on key genetic markers
• People whose kidneys are functioning at or above a minimum level, based on a standard blood test (confirm with trial site)
• People whose heart is pumping adequately, based on a heart scan or ultrasound
• People whose lungs are functioning at or above a minimum level, based on a breathing test
• People who test negative for pregnancy (if there is any possibility of pregnancy)
• People whose liver enzyme levels are within an acceptable range on blood tests
• People who have been assessed by the lead doctor as not being suitable for a higher-intensity (fully myeloablative) stem cell transplant

Who may not be able to join:

• People who have previously had a stem cell transplant from a donor
• People who are currently taking corticosteroids (such as prednisone) at higher than low doses, or other medicines that suppress the immune system
• People for whom a donor lymphocyte infusion (an additional immune cell treatment) is already planned after transplant
• People for whom planned removal or reduction of certain immune cells (T-cells) from the donor material is part of the transplant plan
• People whose immune system has developed antibodies that react against the donor's tissue type
• People whose overall physical functioning falls below a certain level on a standard medical scoring scale (confirm with trial site)
• People in the higher-intensity treatment group who have a high score on a transplant-specific health risk index (confirm with trial site)
• People who have an active, uncontrolled infection (bacterial, viral, or fungal) that is not improving with treatment at the time of joining
• People who test positive for HIV, HTLV, active hepatitis B, or hepatitis C — unless hepatitis C has been successfully cured and confirmed by a specific follow-up test
• People who have a known allergy or serious reaction to the anti-rejection medicine tacrolimus
• People who have a documented allergy or serious reaction to iron dextran or certain proteins derived from bovine (cow), murine (mouse), algal, or specific bacterial sources
• People with an uncontrolled autoimmune disease that requires ongoing immune-suppressing treatment
• People who have had another cancer diagnosed within the past year, except for a type of skin cancer (non-melanoma) that has been fully removed
• People whose personal or social circumstances may make it very difficult to go through the transplant process or attend required follow-up care
• People who are currently pregnant or breastfeeding
• People who are capable of becoming pregnant, or men who have sexual contact with people who could become pregnant, who are unwilling to use reliable contraception or abstinence for one year after the transplant
• People with any other serious medical condition or abnormal test result that the doctor believes would make participation unsafe or affect the reliability of the trial results

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