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:

• Adults between 18 and 75 years old
• People who have a matching stem cell donor — either a family member (sibling) who matches on 6 out of 6 key genetic markers, or an unrelated donor who matches on 8 out of 8 key genetic markers — and that donor must be willing and medically cleared to donate
• People for whom doctors have determined a lower-intensity (gentler) preparation treatment is more appropriate, based on age (60 or older), a certain health risk score (HCT-CI of 4 or higher), or a doctor's judgement that a full-strength preparation would carry too much risk
• People whose heart is pumping at greater than 40% of normal capacity
• People whose kidneys are filtering at a rate greater than 50 mL per minute, as measured by a standard formula
• People whose lungs are functioning at 50% or above on standard breathing tests (DLCO and FEV1)
• People whose liver function blood tests are within acceptable ranges (confirm with trial site for exact values); those with a condition called Gilbert's Disease may still be eligible with slightly higher bilirubin levels
• Women who are not post-menopausal (for at least 1 year) or surgically sterilised, and who agree to use two effective forms of contraception, or to abstain from heterosexual intercourse, from signing consent through 12 months after the transplant
• Men (including those who have had a vasectomy) whose partner could become pregnant, and who agree to use effective barrier contraception or abstain from heterosexual intercourse from signing consent through 12 months after the transplant
• People with a general health and activity score (Karnofsky Performance Status) of 70 or above
• People diagnosed with one of the following blood conditions:
  • Acute Myeloid Leukaemia (AML) with certain high-risk features, including a small amount of detectable disease remaining, unfavourable genetic changes, or specific gene mutations (confirm with trial site for full details)
  • Myelodysplastic Syndrome (MDS) with specific high-risk features, including remaining blast cells above 5% after prior treatment, certain chromosomal abnormalities, or specific gene mutations
  • Myelofibrosis with blast cells present in the blood
• People who are willing and able to give informed consent and follow the study requirements

Who may not be able to join:

• People who had their own stem cells transplanted (autologous transplant) fewer than 3 months before enrolling
• People with a more advanced level of AML, where more than 5% blast cells remain in the bone marrow or blast cells are circulating in the blood
• People who have previously had a stem cell transplant from a donor (allogeneic transplant)
• People with uncontrolled chest pain (angina), severe uncontrolled heart rhythm problems, or signs of active heart problems on an ECG
• People with a known allergy or sensitivity to any of the medications used in this study
• People who have taken any experimental drugs within 14 days before the first day of transplant preparation
• People who are pregnant or breastfeeding
• People with HIV infection or a positive HIV test result
• People with an active, uncontrolled bacterial, viral, or fungal infection that is getting worse despite treatment
• People with a confirmed diagnosis of liver cirrhosis
• People who have had a non-blood cancer within the past 3 years — with some exceptions, such as certain treated skin cancers or cervical cancer in situ; cancers treated with the intent to cure 5 or more years ago may be considered, and those treated less than 5 years ago would need to be reviewed by the lead researcher
• People who have participated in another clinical trial using an experimental treatment within the past 28 days

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