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 able to understand the study and are willing to sign a written consent form.
• People who have been diagnosed with a specific type of blood cancer — either a secondary form of acute myeloid leukaemia (AML) that developed from a prior blood or bone marrow condition, or a high-risk form of myelofibrosis with excess abnormal cells in the bone marrow (more than 5%).
• People whose cancer has come back, stopped responding to treatment, or who could not tolerate available treatments — including chemotherapy, epigenetic therapies (such as azacitidine or decitabine), or venetoclax, and targeted treatments where relevant to their specific mutation type.
• People who have had at least one prior line of treatment if they were not able to receive intensive chemotherapy, or at least two prior lines of treatment if they did receive intensive chemotherapy.
• People whose kidneys are functioning well enough, based on a calculation of kidney filtering ability greater than 60 mL/min (confirm with trial site).
• People who have recovered from the side effects of any previous treatment back to their usual health baseline.
• People aged 18 years or older.
• People of any gender, race, or ethnic background.
• Women who could become pregnant must agree not to become pregnant during the study, and both men and women must agree to use barrier contraception during the study and for 10 weeks after the last dose of the study drug (rebecsinib).
• Women who could become pregnant must have a negative pregnancy test before joining.
• People with a performance status score of 0–2 on the ECOG scale, meaning they are able to carry out at least some daily activities independently (confirm with trial site).
• People with a haemoglobin level of at least 8.0 g/dL (a measure of red blood cells in the blood).
• People with liver function blood test results within an acceptable range — specifically, total bilirubin no more than 1.5 times the upper limit of normal, and liver enzymes (ALT and AST) also no more than 1.5 times the upper limit of normal.
• People with blood clotting results within an acceptable range (INR no more than 2, and partial thromboplastin time no more than 1.66 times the upper limit of normal).

Who may not be able to join:

• People who are pregnant or breastfeeding.
• People who have previously had a bone marrow or stem cell transplant.
• People who are currently taking part in another clinical trial or receiving another experimental treatment.
• People who have received chemotherapy, immunotherapy, or any investigational drug within the past 2 weeks or within 5 half-lives of that drug (whichever is longer) before starting the study drug.
• People who currently have an active infection that requires antibiotic treatment through a drip or injection.
• People with an active HIV, hepatitis B (HBV), or hepatitis C (HCV) infection.
• People who have had another type of cancer within the past 3 years, except for certain early-stage or skin cancers that were completely removed.
• People whose cancer has spread to the brain or spinal cord (the central nervous system).
• People with an untreated autoimmune condition affecting blood cells, such as autoimmune haemolytic anaemia or immune thrombocytopenia.
• People with an underactive thyroid that is not being treated with hormone replacement, where thyroid levels are significantly above the normal range.
• People who have not sufficiently healed from a recent surgical wound.
• People with significant heart problems, including: a heart attack within the past 6 months; a history of abnormal heart rhythm readings (specifically a QTc interval of 470 milliseconds or more on a heart tracing); or other serious heart conditions such as heart failure, poorly controlled high blood pressure, or a history of not following a blood pressure treatment plan.
• People with a QT interval reading above 470 milliseconds on a heart tracing test (ECG) at the time of screening.
• People currently taking certain medications that affect how the liver processes drugs — specifically those that interact with enzymes known as CYP3A4, CYP2C9, CYP2C19, CYP2B6, or certain liver transporters (confirm specific medications with the trial site).
• People who the trial doctor believes may not be able to safely follow the monitoring and safety requirements of the study.

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