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 diagnosed with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS), or mixed/biphenotypic leukemia (MPAL) that fits one of several specific disease situations, including: being in first remission but still showing signs of remaining disease on testing; having relapsed at least once after treatment; having disease that never responded to treatment; AML that developed from a prior bone marrow disorder; a specific type of MDS called RAEB; or a condition called chronic myelomonocytic leukemia (CMML).
• People whose leukemia cells carry a specific marker called CD45, if they are not currently in remission (those in remission do not need this confirmed).
• People aged 18 to 75 years old.
• People whose circulating leukemia cell count is below 10,000 per cubic millimetre (medication to help control this count is permitted).
• People whose kidneys are functioning well enough, based on a specific calculation using a recent blood test result taken within the past 28 days.
• People whose liver blood test results (bilirubin, AST, and ALT) are within acceptable ranges.
• People who are well enough to carry out daily activities, as measured by standard medical scoring tools (confirm with trial site).
• People who do not have any uncontrolled infections at the time of joining.
• People who previously received a less intensive bone marrow transplant from a donor, provided there is no ongoing graft-versus-host disease (GVHD) and all immune-suppressing medications have been stopped for at least six weeks before enrolling.
• People whose liver stiffness scan (elastography) result is normal.
• People whose iron levels in the liver are below a certain amount, if a ferritin blood test shows elevated iron (confirmed by a specific liver MRI scan).
• People who have had a specialist digestive health (gastrointestinal) assessment before the transplant.
• People who have a related family donor who shares exactly half of their tissue-matching (HLA) markers, with specific allowable differences in certain HLA markers (confirm with trial site for details).
• Donor: The donor must meet the HLA matching requirements described above and also meet standard donor health criteria set by the Seattle Cancer Care Alliance for stem cell or bone marrow donation.

Who may not be able to join:

• People with active heart disease causing symptoms, or who are taking heart medications to control heart rhythm or heart pumping strength.
• People whose heart pumping function (left ventricular ejection fraction) is below 45%.
• People whose lung function is significantly reduced — specifically, a carbon monoxide diffusion capacity below 35% — or who need continuous supplemental oxygen; people unable to complete lung function tests may instead undergo a six-minute walk test, and those whose blood oxygen drops below 89% during that test would not be eligible.
• People with serious liver conditions, including liver failure, cirrhosis with complications, alcoholic hepatitis, certain vein problems in the liver, liver-related brain problems, ongoing viral hepatitis, or other significant liver diseases (confirm with trial site for the full list).
• People known to be HIV positive.
• People who, in the medical team's assessment, would not be able to tolerate the procedures involved in the trial.
• People who have active leukemia affecting the brain or spinal fluid at the time of treatment.
• People who have previously had a full-intensity (myeloablative) bone marrow or stem cell transplant from a donor.
• People who are pregnant or breastfeeding.
• People who are capable of having children but are unwilling to use contraception during the trial and for 12 months after the transplant.
• People who are unable to understand the trial or provide informed consent.
• People with a known allergy to a specific type of laboratory-made antibody derived from mouse proteins (murine-based monoclonal antibodies).
• People with known medical reasons why radiation therapy would not be safe for them.

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