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 18 or older (there is no upper age limit)
• People whose most recent stem cell transplant came from a donor who was a close tissue-type match (10 out of 10 markers matched) from either a related or unrelated donor
• People whose blood counts recovered at some point after transplant, even if that recovery did not last — specifically, white blood cell and platelet counts reaching certain minimum levels without the help of growth factor injections or platelet transfusions for at least 5 days
• People whose anti-rejection medications have been stopped, stayed the same, or been reduced over the past 4 weeks, with no flare-up of graft-versus-host disease (a condition where transplanted cells attack the body) during that time
• People who are in reasonably good physical condition, able to carry out normal activity with only minor limitations (as measured by a standard performance scale)
• People who agree to use a reliable method of contraception during the study treatment and for 4 months after the last dose of the study drug
• People who are able to give informed consent to participate

Group 1 only (people being treated for signs of returning or remaining disease after transplant):

• People whose AML (a type of blood cancer) or MDS (a bone marrow disorder) shows measurable signs of remaining disease after transplant, but at a low level — specifically, less than 5% abnormal cells detected in the bone marrow by specialised testing done at the University of Washington Medical Center or Fred Hutchinson Cancer Center laboratory
• People who do not have abnormal cancer cells circulating in their blood
• People who do not have disease that has spread outside the bone marrow
• People whose post-transplant monitoring never showed a full relapse (defined as 5% or more abnormal cells, circulating cancer cells in the blood, or disease outside the bone marrow)
• People who are at least 60 days past their transplant date (there is no upper time limit)
• People for whom no FDA-approved targeted treatment exists for their specific AML or MDS, or for whom such treatments have previously been tried and did not work, or who were unable to tolerate them

Group 2 only (people receiving the study drug alongside or shortly after transplant):

• People whose transplant used a specific approach to reduce the risk of immune complications, involving either post-transplant cyclophosphamide or another method of reducing certain immune cells (confirm with trial site)
• People who gave informed consent before their transplant or by day 28 after transplant (treatment may begin as early as 30 days after transplant)
• People with AML (as defined by specific 2022 medical classification systems) whose pre-transplant bone marrow testing showed remaining leukaemia detectable by specialised flow cytometry testing
• People with AML who had at least one round of intensive chemotherapy, or at least two cycles of a specific lower-intensity drug combination, or at least four cycles of another lower-intensity therapy before their transplant
• People with MDS who had at least one of the following high-risk features before their transplant:
  • A very high-risk score on a specific MDS risk classification system
  • A particular gene mutation (TP53) present in 50% or more of tested cells
  • The same TP53 gene mutation present in less than 50% of cells along with certain chromosome abnormalities
  • Two copies of a TP53 gene mutation
  • Prior treatment with chemotherapy or lower-intensity therapies where the bone marrow still showed more than 5% abnormal cells before transplant

Who may not be able to join:

• People who received a cell-based immune therapy or a new targeted treatment within the 4 weeks before the first study injection
• People who had a severe (grade 3 or 4) acute graft-versus-host disease reaction after their most recent transplant
• People who had moderate or severe long-term (chronic) graft-versus-host disease after their most recent transplant
• People who have had active graft-versus-host disease or certain immune-related complications in the past month that required systemic treatment (low-dose steroid use for a specific hormonal condition is allowed)
• People with an active moderate to severe blood vessel disorder called thrombotic microangiopathy, shown by certain blood test results or symptoms such as high blood pressure, worsening kidney function, or neurological problems attributed to this condition in the past 4 weeks
• People with significantly reduced kidney function (below a certain threshold on standard kidney tests)
• People who required dialysis in the past 4 weeks
• People who had a major heart event requiring emergency care or hospitalisation in the past 4 weeks
• People with moderate or worse heart failure symptoms in the past 4 weeks
• People with uncontrolled irregular heart rhythms, including atrial fibrillation
• People whose heart pumping function is below 35% as measured by a heart scan
• People with significantly elevated liver enzyme levels or bilirubin (a liver-related chemical) above certain thresholds
• People with an active, uncontrolled infection — some infections that are being treated and responding to treatment may still be acceptable (confirm with trial site)
• People with significant lung problems, including the need for supplemental oxygen even occasionally in the past 2 weeks, lung function test results below 60% of expected, or certain specific lung conditions
• People who had a seizure in the past 4 weeks, or who have a significant active neurological condition such as Parkinson's disease, multiple sclerosis, epilepsy, or prior stroke — certain nerve-related conditions from diabetes or prior chemotherapy may be acceptable
• People with other medical, social, or mental health factors that the lead researcher determines would make participation inappropriate or difficult
• People with a known allergy to any component of the study treatment
• People currently taking another experimental cancer treatment
• People whose transplant immune cell levels (specifically T cell donor chimerism) are below 40% in the blood
• People who are pregnant or breastfeeding

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