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 aged 18 or older.
• People with a confirmed diagnosis of myelodysplastic syndrome (MDS) rated as intermediate-2 or high risk on a standard medical scoring system (IPSS), OR a type of blood cancer called Acute Myeloid Leukaemia (AML) with 20–30% abnormal cells in the bone marrow with certain features, OR a condition called chronic myelomonocytic leukemia (CMML) with 10–29% abnormal cells in the bone marrow meeting specific criteria.
• People whose general health and ability to carry out daily activities meets a certain standard (rated 0 or 1 on a scale used by doctors called the ECOG scale, meaning fully active or restricted in strenuous activity only).
• People who have been assessed as not suitable for a bone marrow/stem cell transplant from a donor.
• People born female who are capable of becoming pregnant must agree to use at least two highly effective forms of contraception during the study and for 6 months after the last dose, and must have a negative pregnancy test at the start of the study.
• People born male whose partner could become pregnant must agree to use at least two highly effective forms of contraception during the study and for 6 months after the last dose, and must agree not to donate sperm during that time.
• People who are willing and able to provide signed written consent before any study procedures begin.

Who may not be able to join:

• People with AML where 30% or more of their bone marrow cells are abnormal blast cells.
• People who have previously had a stem cell or bone marrow transplant of any kind.
• People who have already received more than one cycle of a type of treatment called a hypomethylating agent.
• People showing signs of certain serious complications related to their blood cancer, including involvement of the brain or spinal cord, a serious blood-clotting disorder (disseminated intravascular coagulation), or a dangerous build-up of cancer cells in the lungs.
• People who have used certain blood-stimulating medications (such as drugs that boost platelet or red blood cell production) or another clinical trial treatment within the 28 days before starting the study.
• People who are taking, or plan to take, certain medications, supplements, herbal remedies, or foods that could interact with the study drug called defactinib — including specific types of drugs that strongly affect how the body processes medications (confirm with trial site for a full list).
• People currently taking the blood-thinning medication warfarin, unless they are willing and able to switch to an alternative blood thinner as directed by their doctor.
• People who have been taking a medication called hydroxyurea (hydrea) for more than 7 days before the study start date.
• People using steroid medications (corticosteroids), unless the dose is low (equivalent to 10mg or less of prednisolone per day) and is being taken for a condition other than MDS.
• People with active inflammatory bowel disease or other significant digestive conditions that could affect how the body processes the study medications.
• People with a history of another cancer within the past 12 months (some skin cancers and very early-stage cancers may be exceptions — confirm with trial site).
• People with significant heart problems in the past 6 months, including severe heart failure, unstable chest pain, or a heart attack.
• People whose heart electrical activity (measured by an ECG) shows a certain reading above a set level (above 440 milliseconds for males or 450 milliseconds for females).
• People with an active, ongoing infection that has not improved with treatment, an active Hepatitis B infection, or certain HIV or Hepatitis C conditions that do not meet specific health criteria (confirm with trial site for individual assessment).
• People whose blood test results show certain abnormal levels of liver function markers, bilirubin, kidney function, or white blood cell count that fall outside the limits set by the trial.
• People with a known allergy or sensitivity to the study drugs or their ingredients.
• People who are pregnant or breastfeeding.
• People with any other medical condition that, in the treating doctor's opinion, could put them at risk or make it difficult to complete the study.

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