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 are willing to give their consent to participate
• People aged 18 or older at the time of screening; both sexes are eligible
• People whose chronic myeloid leukemia (CML) has come back or stopped responding to a third-generation targeted therapy (called a TKI)
• People without a specific gene change called T315I mutation who have previously been treated with first-, second-, and third-generation TKI therapies
• People with the T315I gene mutation who have previously been treated with Olverembatinib or Ponatinib
• People diagnosed with CML in the accelerated phase (CML-AP), confirmed by bone marrow, molecular, or genetic testing
• People with a general health score (called ECOG) of 2 or below, meaning they are able to care for themselves and are up and about more than half of waking hours
• People with a life expectancy of at least 3 months
• People with blood counts, kidney, liver, pancreatic, and clotting function that meet the trial's required levels (confirm with trial site)
• People with a normal heart rhythm measurement (QTc interval) on an electrocardiogram (ECG)
• Women of childbearing potential who have a negative pregnancy test at screening
• People who are willing to use contraception throughout the study (applies to men and women of childbearing potential)

Who may not be able to join:

• People who have received TKI treatment, or who still have unresolved side effects from TKI treatment, within 7 days before the first dose
• People who are currently receiving other anti-cancer treatments
• People who require immune-suppressing medications
• People who have taken medications known to affect heart rhythm in a specific way (associated with Torsades de Pointes) within 1 month before screening
• People who have other medical conditions requiring medications that may interact with the trial drug
• People who have previously had a blood stem cell transplant
• People with active conditions affecting the central nervous system (brain and spinal cord)
• CML-AP patients who have already achieved a major response in their blood counts
• CML-AP patients whose disease has previously progressed to the blast phase (a more advanced stage)
• People with uncontrolled or active heart or blood vessel disease
• People with a history of heart or cardiovascular conditions — except those with high blood pressure that has been controlled by medication, keeping blood pressure no higher than 160/100 mmHg for at least 1 month before screening
• People who have taken Traditional Chinese Medicine intended for anti-cancer purposes within 2 weeks before the first dose
• People with a serious bleeding disorder unrelated to CML
• People who had a serious heart or cardiovascular problem during past TKI treatment for CML
• People with a history of pancreatic inflammation or alcohol misuse within 3 years before the first dose
• People with uncontrolled high levels of triglycerides (a type of fat) in the blood
• People with conditions that may affect how the body absorbs medication
• People diagnosed with another primary cancer within the past 5 years
• People who have had major surgery within 14 days before the first dose
• People with an ongoing or active infection, including HIV, hepatitis B, or hepatitis C
• People whom the trial investigators consider unsuitable for the study for other medical reasons

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