Phase 1 Leukaemia Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who have been diagnosed with Acute Myeloid Leukaemia (AML) or higher-risk Myelodysplastic Syndrome (MDS) — confirmed by a pathology report using the latest WHO 2022 guidelines — with at least 10% abnormal cells (blasts) in the bone marrow. Note: a specific subtype called acute promyelocytic leukaemia cannot be included, but AML that developed from prior treatment or another condition can be.
- People whose general physical health and ability to carry out daily activities meets a certain minimum level, rated on a standard medical scale (ECOG score of 2 or below, meaning someone who is up and about and capable of self-care, even if unable to work).
- People whose liver and kidney function tests show adequate results, taken within 7 days before starting the study drug.
Who may not be able to join:
- People who have had a stem cell transplant (using their own or a donor's cells) within the 6 months before the trial starts.
- People currently taking immune-suppressing medications (such as cyclosporin) or steroid medicines taken throughout the body — except steroids used to replace a hormone called cortisol in people with a documented adrenal gland condition.
- People with an active fungal illness or any infection that is not under control; people taking antibiotic, antifungal, or antiviral treatment must have had no fever and stable vital signs for more than 72 hours before joining.
- People whose white blood cell count is too high (above a certain level measured within 7 days before starting the study drug) — although a medication called hydroxyurea may be permitted to bring that count down first (confirm with trial site).
- People who still have significant side effects from a previous treatment that have not sufficiently settled down — with specific thresholds depending on the type of side effect (for example, tiredness and nerve-related symptoms must have improved to a mild level; hair loss and skin colour changes are exceptions).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Phone: 508-543-6979
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Where this trial is recruiting
Primary endpoints
Incidence and severity of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0; Incidence and severity of dose-limiting toxicities (DLTs) in DLT evaluable patients during Cycle 1; Preliminary clinical activity as evaluated per European LeukemiaNet (ELN) 2022 criteria for AML and International Working Group (IWG) 2023 criteria for HR-MDS
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.