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 have been diagnosed with high-risk myelodysplastic syndromes (MDS), treatment-related MDS, or acute myeloid leukemia (AML) that has come back or has not responded to previous treatment.
• People whose blood test shows a sufficient level of certain immune cells (lymphocytes or NK cells) within 14 days before treatment starts.
• People whose blood cancer cell count is at or below a certain level at the start of treatment (a medication called hydroxyurea may be used beforehand to reach this level).
• People who are reasonably active and able to carry out daily activities, as measured by a standard performance scale (a score of 70% or higher on the Karnofsky scale).
• People whose heart, liver, kidneys, and other organs are functioning well enough, confirmed by tests done within 14 days (or 30 days for heart tests) before treatment starts.
• People who are sexually active and could potentially conceive a child, or whose partner could, must agree to use a highly effective form of contraception during the study and for at least 4 months after the last dose of the study drug.
• People who are able to breathe room air comfortably, with an oxygen level of 95% or higher.
• People who are willing and able to give written consent before any study-related activities begin.
• For one part of the study only: People who are able to stay within a 60-minute drive of the study centre through the first 29 days of treatment.

Who may not be able to join:

• People who are pregnant or breastfeeding, or who cannot confirm a negative pregnancy test within 7 days before treatment starts.
• People who are considered suitable candidates for a stem cell transplant, or who have recently relapsed after a stem cell transplant and have not yet received any further treatment.
• People whose leukemia involves a mixed or combined cell type (bi-phenotypic or mixed lineage leukemia).
• People diagnosed with a specific type of leukemia called acute promyelocytic leukemia (APL).
• People who have received any cancer treatment within 14 days before the start of the study, or who still have side effects from previous treatment that have not settled back to a mild or baseline level.
• People who have new or worsening areas of concern in the lungs seen on a chest X-ray or CT scan, unless a lung specialist has cleared them for the study (lung changes due to infection must be stable or improving after appropriate treatment).
• People who have an active serious infection currently being treated with intravenous antibiotics.
• People with a known history of HIV.
• People with active Hepatitis B or Hepatitis C (where the virus is detectable by a specific blood test); people with chronic but symptom-free viral hepatitis may still be considered (confirm with trial site).
• People who test positive for Hepatitis B surface antigen or Hepatitis C antibodies.
• People with a history of another cancer, except for certain early-stage or fully treated cancers, or cancers from which the person has been free of disease for at least one year.
• People with cancer that has spread to the brain or spinal cord, or who have active symptoms suggesting this, or who have received chemotherapy directly into the spinal fluid within 14 days before the study starts.
• People with cancer that has spread outside the bone marrow and is causing symptoms, or that involves the brain or spinal canal.
• People with an active autoimmune condition currently being treated with steroids or immune-suppressing medications within 14 days before treatment starts (low-dose or inhaled/topical steroids may be permitted — confirm with trial site).
• People who need ongoing treatment with higher-dose steroids or other immune-suppressing medications within 14 days before treatment starts.
• People whose heart tracing (ECG) shows a specific measurement (QTc interval) above 480 milliseconds, or who have a family history of a heart condition called long QT syndrome.
• People with a psychiatric illness or personal circumstances that the study doctor believes would make it difficult to follow the study requirements.
• People with any other health condition that the study doctor believes would make participation unsafe or unsuitable.

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