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:

• Adults between 18 and 75 years of age
• People who have a suitable stem cell donor available — either a close relative (such as a sibling) or an unrelated person whose tissue type closely matches theirs, and who is willing and medically cleared to donate stem cells
• People whose doctor has determined that a lower-intensity treatment approach is more appropriate for them, based on their age (60 or older), overall health score, or risk of serious side effects from a stronger treatment
• People whose heart is pumping at more than 40% of normal capacity
• People whose kidneys are filtering at a sufficient level (confirmed by a blood test using a standard formula)
• People whose lungs are functioning at 50% or more of expected levels on breathing tests
• People whose liver function blood test results are within acceptable ranges (those with a condition called Gilbert's Disease may still be eligible with slightly higher bilirubin levels — confirm with trial site)
• Women who are not post-menopausal or surgically sterilised must agree to use two reliable forms of contraception, or complete abstinence, from signing the consent form through to 12 months after transplant
• Men (including those who have had a vasectomy) whose partners could become pregnant must agree to use barrier contraception or complete abstinence from signing the consent form through to 12 months after transplant
• People who are relatively independent in daily functioning, as measured by a standard health performance scale (score of 70 or above out of 100)
• People diagnosed with one of the following blood or bone marrow conditions, meeting specific disease criteria:
  • A type of blood cancer called AML (acute myeloid leukaemia), under certain conditions relating to disease activity, risk level, or stage of remission
  • A bone marrow disorder called MDS (myelodysplastic syndrome), rated as high risk or with a significant number of abnormal cells, where other treatments are not available or are not expected to work
  • A combined bone marrow condition called MDS/MPN, with more than 5% abnormal cells and a spleen size below a certain threshold, where other treatments are not available or are not expected to work
• People who are willing and able to sign a consent form and follow the requirements of the study

Who may not be able to join:

• People who received their own stem cells as a transplant (autologous transplant) less than 3 months before enrolling
• People who have previously received a stem cell transplant from a donor (allogeneic transplant)
• People with uncontrolled chest pain, serious uncontrolled heart rhythm problems, or signs of an acute heart event or electrical conduction problem on a heart tracing (EKG)
• People with a known allergy or sensitivity to the study drugs Decitabine, Venetoclax, or ATG
• People who are pregnant or breastfeeding
• People who have HIV infection or a positive HIV blood test result
• People with a current, uncontrolled bacterial, viral, or fungal infection that is worsening despite treatment
• People who have had a non-blood-related cancer within the past 3 years, with some exceptions (such as certain treated skin cancers or cervical changes); cancers treated with curative intent 5 or more years ago and currently in remission may be considered, and those treated less than 5 years ago must be reviewed and approved by the lead trial doctor
• People who have taken part in another clinical trial involving an experimental treatment within the last 28 days
• People with a confirmed diagnosis of liver cirrhosis

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