Phase 1 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 signed a consent form agreeing to take part in the study
• Adults aged 18 years or older and younger than 75 years
• People diagnosed with chronic myeloid leukaemia (CML) in the chronic phase or accelerated phase, confirmed by specific genetic markers in their blood or bone marrow
• People with CML in the chronic or accelerated phase whose leukaemia has stopped responding to previous targeted therapy medicines (TKIs), or who could not tolerate those medicines
• People who are reasonably well and able to carry out daily activities, based on a standard medical fitness scale (ECOG score of 0, 1, or 2)
• People expected to live for at least 12 weeks
• People who are willing and able to use effective contraception throughout the study; women must not be breastfeeding during the study or for 6 months after it ends
• Women who are confirmed to not be able to become pregnant (confirm with trial site)

Who may not be able to join:

• People with CML in the chronic phase who have already achieved a complete response to treatment and have not lost that response
• People with CML in the chronic phase whose disease has progressed to the accelerated or blast phase
• People with CML in the accelerated phase who have already achieved a full blood count response or have no detectable CML in their blood
• People with CML in the accelerated phase whose disease has progressed to the blast phase
• People who have previously been treated with a specific type of targeted therapy called a BCR-ABL1 allosteric inhibitor
• People with certain heart problems, including: an abnormal heart rhythm reading on an ECG test; a very slow resting heart rate (under 50 beats per minute); a weakened heart pumping function; a heart attack within the past 6 months; heart failure within the past 6 months; uncontrolled chest pain (angina); or other significant heart rhythm or electrical abnormalities
• People who have had acute pancreatitis (sudden inflammation of the pancreas) within the past year, or who have a history of chronic pancreatitis
• People with severe or poorly controlled conditions such as high blood pressure or diabetes
• People with serious digestive system problems that could affect how the study medicine is absorbed or processed
• People who have had a serious infection within the 4 weeks before starting the study
• People with a significant history of unusual or uncontrolled bleeding problems not related to their leukaemia
• People with poor function in other major organs (confirm with trial site)
• People with a history of another cancer
• People with a known allergy to any ingredient in the study medicine (HS-10382)
• People with a history of nerve problems or mental health conditions, including epilepsy or dementia
• People who the trial doctor believes are unlikely to be able to follow the study's requirements or procedures

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