Phase 1 Leukaemia Trial, Recruiting

Written by an AI model from the 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 12 to 78 years (or 12 to 65 years, depending on the type of transplant and donor match — confirm with trial site)
• People diagnosed with acute myeloid leukemia, acute lymphoblastic leukemia, mixed phenotype leukemia, or high/very high risk myelodysplastic syndrome (MDS), where the disease is either in full remission or has a low level of abnormal cells in the bone marrow (no more than 10%)
• People for whom a stem cell transplant from a donor (called an allogeneic transplant) has been recommended by their doctor
• People who have a matched or partially matched donor — either related or unrelated — or a half-matched (haploidentical) related donor
• People whose kidneys are working above a minimum level of function (the specific threshold depends on the type of transplant — confirm with trial site)
• People whose heart is pumping adequately (at least 45% function for full-intensity transplant, or at least 40% for reduced-intensity transplant)
• People whose lungs are functioning above a minimum threshold (at least 50% for full-intensity transplant, or at least 40% for reduced-intensity transplant)
• People whose liver function blood tests are within acceptable ranges (the specific limits depend on the type of transplant — confirm with trial site)
• People enrolling in the reduced-intensity transplant arms must be assessed by the lead doctor as being unsuitable for a full-intensity transplant

Who may not be able to join:

• People who have previously had a donor stem cell transplant
• People currently taking corticosteroids (steroids) or other immune-suppressing medicines, with some exceptions — low-dose steroids (10 mg per day or less) or topical steroids may be allowed, as may treatments specifically approved for their blood condition
• People whose transplant plan includes a procedure called donor lymphocyte infusion (DLI)
• People whose transplant plan includes certain methods of removing or reducing T cells from the donor cells (such as post-transplant cyclophosphamide or alemtuzumab)
• People who have antibodies in their blood that react against their donor's tissue type (confirm with trial site)
• People with a low performance/fitness score below the required threshold (the minimum score depends on the type of transplant — confirm with trial site)
• People with a high level of health complications as measured by a transplant-specific scoring tool, above the allowed limit for their transplant type (confirm with trial site)
• People with an active, uncontrolled bacterial, viral, or fungal infection that is not improving with treatment at the time of enrolment
• People who test positive for HIV-1 or HIV-2, HTLV-1 or HTLV-2, active Hepatitis B, or Hepatitis C
• People with an uncontrolled autoimmune disease that currently requires immune-suppressing treatment
• People who have had another cancer within the past year, or have a current active cancer — with some possible exceptions for certain slow-growing blood cancers under monitoring only, subject to approval (confirm with trial site)
• People with a history of myelofibrosis (scarring of the bone marrow), whether inherited or acquired
• People who are pregnant or breastfeeding

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