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:

• The person must be between 18 and 75 years old.
• The person must have a diagnosis of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that is considered high-risk based on standard medical scoring systems, or have signs of active or residual disease at the time of a stem cell transplant.
• The person must be either preparing for their first or second donor stem cell transplant (allogeneic HCT), or must have already had one for AML or MDS.
• The person's cancer cells must have tested positive for a specific protein called CD123, based on blood or bone marrow testing done before the transplant.
• The person must be well enough to carry out basic daily activities (this is measured using a standard medical scale called ECOG, with a score of 2 or lower).
• Any type of donor or transplant method is allowed (for example, matched or mismatched donors, related or unrelated donors, different sources of stem cells).
• Any preparation treatment or anti-rejection medication used around the transplant is allowed.
• Previous treatment targeting CD123 is allowed, as long as the disease did not get worse while on that treatment.
• The person must agree to provide a stored tissue sample from a previous biopsy, or an exception may be granted by the lead researcher if no sample is available.
• The person must give written consent to take part in the trial.
• People of childbearing potential must agree to use effective contraception or abstain from heterosexual activity during the study and for at least 6 months after the last treatment dose.
• For the maintenance treatment phase specifically, the person must show either complete remission or minimal remaining disease on a bone marrow test done on day 30 after transplant.
• For the maintenance treatment phase, the person's body must have fully accepted the transplanted cells, shown by stable blood counts meeting specific thresholds for at least several days.
• For the maintenance treatment phase, the person must have blood counts, liver function, kidney function, and protein levels within acceptable ranges, based on tests taken within 7 days of starting treatment (blood transfusions to help reach required blood count levels are allowed).
• For the maintenance treatment phase, the person must not have active graft-versus-host disease (GVHD), though a low dose of the steroid prednisone (10 mg per day or less) is allowed.
• For the maintenance treatment phase, women who could become pregnant must have a negative pregnancy test within 7 days of starting treatment.
• For the maintenance treatment phase, the person must not have received any other experimental treatment within 14 days before starting.
• For the maintenance treatment phase, any side effects from previous treatments must be mild and well managed (with exceptions for hair loss, nausea, and fatigue).

Who may not be able to join:

• People who have had a significant allergic reaction to medicines similar to the study drugs (tagraxofusp or azacitidine).
• Women who are pregnant or breastfeeding.
• People with another active cancer, or a history of cancer within the past 2 years that has a meaningful chance of returning — though certain low-risk conditions such as non-melanoma skin cancer, carcinoma in situ, cervical intraepithelial neoplasia, or contained prostate cancer with no signs of progression may still be eligible.
• People with serious heart problems, such as severe heart failure, uncontrolled chest pain, a heart attack or stroke within the past 6 months, uncontrolled high blood pressure, or a significant heart rhythm problem not controlled by medication.
• People with serious, uncontrolled lung disease (such as COPD or pulmonary hypertension) that the doctor believes would create a significant risk during the study.
• People with known or suspected disease affecting the brain or spinal cord (CNS disease).
• People with active hepatitis B, hepatitis C, or HIV infection.
• People with any other serious or uncontrolled condition — including uncontrolled infection, a blood clotting disorder, or mental health or personal circumstances — that the doctor believes would make participation unsafe or very difficult.
• People who, in the doctor's judgment, are unlikely to be able to follow all study procedures.

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