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:

• People who have been newly diagnosed with a type of blood cancer called AML (acute myeloid leukemia), where the treating doctor has planned standard treatment using two drugs called decitabine and venetoclax
• People whose AML has come back for the first time after previous treatment, and where the treating doctor considers decitabine and venetoclax to be the appropriate standard treatment
• People with certain AML gene mutations (IDH or FLT3) where the treating doctor prefers to add extra targeted medicines alongside decitabine and venetoclax
• People who have a general health and activity level rated at 2 or below on a standard medical scale (meaning able to care for themselves, though possibly not able to do heavy physical work) (confirm with trial site)
• People whose liver, kidney, and bone marrow are functioning within acceptable ranges as measured by standard blood tests
• People who are willing and able to use reliable contraception (such as hormonal methods, barrier methods, or abstinence) throughout the study period
• People who are able to understand the study and are willing to sign a written consent form

At a later stage in the trial, additional criteria apply, including:

• People who have responded at least partially to decitabine and venetoclax treatment
• People who have recovered from serious side effects of that treatment (with the exception of certain anaemia)
• People whose blood counts and organ function still meet required levels at that stage
• People who have completed four full cycles of decitabine and venetoclax with no sign of disease returning or worsening
• People whose immune cells (T cells) can be collected in sufficient numbers to meet the treatment requirements

Who may not be able to join:

• People diagnosed with a specific subtype of AML called acute promyelocytic leukemia
• People newly diagnosed with AML who are considered suitable for a more intensive type of chemotherapy
• People with an active autoimmune disease (where the immune system attacks the body) that requires ongoing treatment — although people with a stable, treated underactive thyroid are an exception
• People who have previously received a bone marrow or stem cell transplant from a donor
• People with active HIV infection, untreated hepatitis C, or active hepatitis B
• People with serious active heart problems, including heart failure, unstable chest pain, or significant heart rhythm problems
• People who are currently pregnant — pregnancy testing will be carried out for people who have not yet reached menopause
• People who are breastfeeding
• People who have used immune-suppressing medications in the 14 days before treatment — with some exceptions such as low-dose steroids, inhaled or topical steroids, or steroids used to prevent allergic reactions (confirm with trial site)
• People who are not willing or able to use effective contraception from the start of treatment through to 90 days after the last dose
• People who choose to proceed with a donor transplant at the time their disease goes into remission

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