Phase 3 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 who have given their informed consent and are willing to take part in the study
• People aged 14 to 70 years old (including those exact ages), of any gender
• People with a general health and activity level rated between 0 and 2 on a standard medical scale (meaning they are able to care for themselves, even if they cannot do heavy physical work)
• People who have been diagnosed with a type of blood cancer called AML (acute myeloid leukaemia) that has a specific genetic change called a FLT3-ITD mutation, confirmed through specialised testing
• People who have successfully received a stem cell transplant from a donor (any type of donor or stem cell source is accepted)
• People whose leukaemia was in full remission before their transplant, but whose blood still showed detectable traces of the FLT3-ITD mutation (at a very low level) within 30 days before the transplant
• People whose body has recovered enough after the transplant — meaning their blood counts have reached a certain level without needing blood product support, they are able to take tablets by mouth, their transplant cells have fully taken hold, and they do not have significant transplant-related complications requiring high-dose treatment
• People whose kidney, liver, and other organ function results fall within acceptable ranges on blood tests
• People who are due to start maintenance treatment between 60 and 90 days after their transplant
• Women who are either past menopause, have had a sterilisation procedure, or — if able to become pregnant — agree to use effective contraception, not become pregnant, not breastfeed, and not donate eggs during the study and for 6 months after the last dose; pregnancy testing is also required during screening
• Men who agree to use effective contraception during the study and for 127 days after the last dose, and agree not to donate sperm during that period

Who may not be able to join:

• People who have a known allergy to the study drugs (Girotinib or Sorafenib) or any of their ingredients
• People with serious other health conditions that could make participation unsafe or make it difficult to follow the study requirements
• People whose leukaemia showed detectable genetic traces of the FLT3-ITD mutation just before starting maintenance treatment
• People who experienced severe organ failure after their stem cell transplant
• People with certain active infections, including active hepatitis B at levels above the centre's normal range (as judged by the research team), active hepatitis C, HIV, or syphilis
• People who, in the 6 months before joining, have had other serious health conditions that could interfere with the study results or seriously threaten their life — such as uncontrolled infections, high blood pressure in the lungs, severe heart failure, unstable chest pain, a recent heart attack, or poorly controlled high blood pressure
• People with a mental health or neurological condition that prevents them from being able to give informed consent or express their wishes clearly
• People who have had an active solid tumour cancer within the past 5 years, except for certain cancers that have been fully treated and cured (such as cervical cancer in situ, localised prostate cancer, or certain skin cancers)
• People who have taken part in, or are currently taking part in, another clinical trial within one month before joining this study
• People whom the research team considers unsuitable for the trial for any other reason

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