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 who have been diagnosed with Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), or a condition classified as MDS/AML, and whose disease is considered high or very high risk of coming back after a stem cell transplant, based on specific medical scoring systems (confirm with trial site)
• People whose bone marrow test, taken before the transplant, shows less than 5% abnormal (blast) cells and no abnormal cells circulating in the blood
• People who are either already planning to have, or have already had, a donor stem cell transplant — any type of transplant preparation or donor type is accepted
• People who are 18 years of age or older
• People whose liver function (bilirubin level) is below a certain threshold — with a special allowance for those with a condition called Gilbert's syndrome (confirm with trial site)
• People whose kidneys are working well enough, based on a measure called creatinine clearance being above a certain level (confirm with trial site)
• People who are reasonably physically active and able to care for themselves, rated 0 or 1 on a standard medical scale called the ECOG scale
• People who are able to understand the study and are willing to sign a consent form and complete study-related steps
• People who enroll no later than 40 days after their transplant, and who — before starting the study treatment — have also met these additional conditions:
  • The transplanted cells have successfully taken hold, shown by blood count levels being stable for at least three days in a row
  • These blood count levels are reached by Day 50 after transplant
  • No active infection at the time of starting treatment
  • No significant transplant-related immune reaction (called graft-versus-host disease, or GVHD) — a mild skin reaction is acceptable
  • A bone marrow test taken at that point shows less than 5% abnormal cells

Who may not be able to join:

• People whose disease got worse while they were previously treated with specific drug combinations known as HMA/VEN therapy or single-agent venetoclax
• People who are already planned to receive a different type of maintenance therapy after their transplant, as decided by their treating doctor
• People who are currently pregnant or breastfeeding; women who could become pregnant must have a negative pregnancy blood test within 72 hours before starting treatment
• People with serious ongoing health conditions that could affect life expectancy or ability to complete the study, including uncontrolled infections, another active cancer, severe heart failure, unstable chest pain, new or unstable heart rhythm problems, severe liver disease, or significant mental health or social circumstances that would make it difficult to follow the study requirements
• People who are unwilling to use two forms of contraception during the study — this applies to women who could become pregnant and to men; anyone who becomes pregnant or suspects pregnancy during the study must inform their doctor immediately
• Sexually active men who are unwilling to use a condom with a partner who could become pregnant, from the screening visit until four weeks after the last dose of study medication
• People with a known active HIV infection; however, people with HIV who have an undetectable viral load, no active opportunistic infections, and who are stable on HIV treatment may still be considered eligible (confirm with trial site)
• People who are known to be allergic or have had a reaction to any ingredient in the study drugs (decitabine or venetoclax)

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