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 are willing to take part and have given their written agreement to participate
• People who are at least 18 years old at the time of screening
• People of any sex
• People who have been diagnosed with chronic myeloid leukaemia in the chronic phase (CML-CP) during the screening period
• People whose leukaemia has stopped responding to, or who cannot tolerate, a type of medication called tyrosine kinase inhibitors (TKIs)
• People who are reasonably able to carry out daily activities, as measured by a standard medical scale (ECOG score of 2 or lower)
• People with adequate levels of certain blood cells (white blood cells, red blood cells, and platelets)
• People whose kidneys and liver are functioning well enough as shown by blood tests
• People with a normal heart rhythm measurement on an ECG (specifically the QTcF interval)
• Women who could become pregnant must have a negative blood pregnancy test at screening
• Women who could become pregnant, or men whose partner could become pregnant, must be willing to use highly effective contraception throughout the trial and for 6 months after the last dose of the study drug

Who may not be able to join:

• People who have recently received other cancer treatments before joining the study
• People who have taken part in another clinical trial or received another experimental treatment within 14 days before starting this study's drug
• People who still have side effects from a previous treatment that are above a mild level (except hair loss)
• People who had a stem cell or bone marrow transplant less than 60 days before the first dose
• People who have graft versus host disease (a complication that can occur after a transplant)
• People currently taking medications that suppress the immune system (other than a short course of steroids)
• People who have taken certain medications known to affect heart rhythm in a specific way (confirm with trial site)
• People with an active disorder of the brain or spinal cord confirmed by cell or tissue testing
• People with significant or uncontrolled heart or blood vessel problems (confirm with trial site for full details)
• People who have long QT syndrome, or whose family has a history of sudden unexplained death or inherited long QT syndrome
• People with uncontrolled high blood pressure
• People who have taken traditional Chinese medicines or herbal preparations used to treat cancer within 2 weeks before the first dose
• People with serious bleeding disorders unrelated to their leukaemia
• People with a history of pancreatitis (inflammation of the pancreas)
• People with a history of heavy alcohol use
• People who have had raised levels of certain pancreas-related enzymes (amylase or lipase) in the past year
• People who have had moderate or severe lung inflammation (interstitial lung disease or pneumonitis) within the 4 weeks before screening
• People with uncontrolled high levels of triglycerides (a type of fat) in the blood
• People with conditions that affect how the body absorbs medication taken by mouth
• People who have been diagnosed with another cancer within the past 3 years
• People who have had major surgery within 14 days before the first dose
• People who have an active infection requiring treatment, or who have had a serious infection within 14 days before joining
• People who are known to be HIV positive, or who have active or chronic hepatitis B or C infection
• People who have received or are due to receive a COVID-19 vaccine within 14 days of joining the study
• People who have had a positive COVID-19 (SARS-CoV-2) PCR test within 2 weeks before screening
• People who are pregnant or breastfeeding
• Women who could become pregnant, or men whose partner could become pregnant, who are unable or unwilling to use highly effective contraception during the trial and for 6 months after the last dose
• People with serious organ problems that the trial doctors believe could affect their safety or the assessment of the study drug
• People who have any other condition that the trial doctors believe makes participation in this trial unsuitable

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