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 who are willing and able to sign a consent form and meet all study requirements.
• People with a confirmed diagnosis of Myelodysplastic Syndrome (MDS) with increased abnormal cells (5% or more), who have previously been treated with a specific type of chemotherapy called a DNMTi, and whose disease got worse after 2 treatment cycles or stayed the same after 4 cycles.
• People with a confirmed diagnosis of Acute Myeloid Leukemia (AML) that has come back or stopped responding to at least one previous treatment.
• People whose white blood cell count is below 25,000/ul before the study starts (a medication called hydroxyurea may be used to help achieve this).
• People who are well enough to carry out basic daily activities, as measured by a standard health scale (score of 0–2 on a recognised performance scale).
• People whose liver and kidneys are functioning adequately, as shown by specific blood test results within acceptable ranges (confirm exact values with the trial site).
• People who are willing to follow all study rules, including using contraception, keeping a daily pill diary, and taking recommended supportive medications.

Who may not be able to join:

• People who have received anti-cancer treatment, including other experimental drugs, within 2 weeks (or within 5 half-lives of the drug, whichever is shorter) before the study starts — though hydroxyurea is permitted.
• People who have not sufficiently recovered from side effects of previous cancer treatment.
• People who have previously been treated with a type of drug called a SINE compound or any drug that blocks a protein called XPO1.
• People who have had a stem cell or bone marrow transplant, or other cell therapy, within the past 3 months.
• People with an active condition called graft-versus-host disease (GVHD) that requires certain immune-suppressing medications, or who stopped a specific type of those medications within the past 4 weeks.
• People who have had radiation therapy or major surgery within the past 3 weeks.
• People with an active infection that is not under control (people with infections being managed with antibiotics may still be eligible — confirm with the trial site).
• People who are unable to swallow tablets or capsules.
• People with leukemia that has spread to the brain or spinal cord.
• People who have had another active cancer within the past 2 years, with the exception of certain skin cancers, early-stage breast cancer confined to the ducts, or early-stage cervical cancer.
• People who are pregnant, could become pregnant and have not tested negative for pregnancy, or who are currently breastfeeding.
• People who have had a significant heart condition or heart procedure (such as bypass surgery or documented heart failure) within the past 6 months.
• People with any other condition that the trial doctor believes would make participation unsuitable.

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