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 acute myeloid, lymphoid, or mixed-type leukemia that is currently in complete remission (the disease is not detectable or is at very low levels), or people diagnosed with a bone marrow disorder called myelodysplastic syndrome (MDS) that is suitable for a stem cell transplant and has fewer than 10% abnormal cells.
• People aged 18 to 70 years old at the time of joining the trial.
• People whose overall health is strong enough to receive an intensive stem cell transplant using one of two specific preparative treatment plans involving radiation or certain chemotherapy drugs.
• People who have a related or unrelated donor available whose tissue type (HLA) is a near-match — specifically a 7 out of 8 match — tested using detailed DNA methods.
• People whose kidneys are functioning at an adequate level, based on a blood or urine test showing kidney filtration rate at or above a certain threshold (confirm with trial site).
• People whose heart is pumping adequately, confirmed by an echocardiogram or similar heart scan.
• People whose lungs are functioning at a sufficient level, based on a specific breathing test result.
• People whose liver function levels are within an acceptable range based on blood tests (people with a condition called Gilbert's syndrome may still be considered once certain causes have been ruled out).
• People who are willing and able to understand and sign a written consent form (a legal representative may provide consent if the person can still verbally agree).
• Women who could potentially become pregnant must have a negative pregnancy test within 3 weeks of joining the trial.
• People with an overall health and activity score of 70% or higher on a standard medical scale, meaning they are able to care for themselves and carry out normal activities.

Who may not be able to join:

• People who have previously had an allogeneic (donor) stem cell transplant.
• People currently taking corticosteroids or other medicines that suppress the immune system, unless the dose is very low or the medication is applied to the skin only.
• People for whom a donor lymphocyte infusion (a specific follow-up treatment using donor immune cells) is already planned.
• People for whom certain immune cell-reducing treatments are planned as part of their transplant care, such as post-transplant cyclophosphamide, ATG, or alemtuzumab (confirm specific details with trial site).
• People whose immune system has developed antibodies that react against the donor's tissue type, detected through specific blood tests.
• People with a bacterial, viral, or fungal infection that is not currently under control, including active tuberculosis.
• People who test positive for HIV, HTLV, active Hepatitis B, or Hepatitis C (a past history of Hepatitis B or C may be considered if the virus is undetectable on a specific blood test — confirm with trial site).
• People with a known allergy or sensitivity to any of the study medications or their ingredients, or to the planned anti-rejection medicines.
• People with a documented allergy to certain proteins used in the manufacturing process, including those derived from bovine (cow), murine (mouse), algal, or specific bacterial sources, or to iron dextran (confirm with trial site).
• People with an autoimmune disease that is not well controlled and requires active treatment.
• People diagnosed with another cancer within the 12 months before joining the trial, except for certain skin cancers that have been fully removed.
• Women who could become pregnant, or men who have sexual contact with women who could become pregnant, who are unwilling to use effective contraception or abstain from sex for one year after the transplant.
• People who have had a heart attack, heart procedure, unstable chest pain, or other significant heart problems within the past 12 months, or a stroke or blood clot in the lungs within the past 6 months.
• People with any other serious medical condition or abnormal test results that the trial doctor believes would make participation unsafe or affect the reliability of the results.

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