Phase 1 Leukaemia Trial, Recruiting NCT06533761 Sponsor: Stelexis BioSciences Condition: Leukaemia
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Phase 1 Leukaemia Trial, Recruiting

NCT06533761
Recruiting Phase 1

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 508-543-6979

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Stelexis BioSciences
Registry
ClinicalTrials.gov
Start date
28 April 2025
Est. completion
15 July 2027

Where this trial is recruiting

🇪🇸 Spain 🇺🇸 United States

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?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov