Phase 2 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:
- The person's organs (such as liver and kidneys) must be working well enough to meet the trial's requirements.
- The person (or their partner) must use contraception in line with local guidelines during the study.
- For Module 1 – the person must have an advanced blood cancer, such as acute leukaemia or a bone marrow condition called myelodysplastic neoplasia (MDS), with specific genetic changes linked to a pathway called HOX (for the dose-escalation part), or specific genetic changes known as KMT2Ar or NPM1m (for the backfill part), confirmed by local testing.
- For Modules 1 and 2 – the person's cancer must have come back or stopped responding to standard treatments, and no other approved treatments must be available to them.
- For Modules 1 and 2 – the person must have previously received at least 2 cycles of standard chemotherapy or similar treatments without success, or must not be suitable for those treatments with no other standard options remaining.
- For Modules 1 and 2 – the person's white blood cell count must be below 25,000 per microlitre at the time of joining (the trial allows for a procedure to reduce cell counts beforehand if needed, under specific trial rules).
- For Modules 1 and 2 – the person must have a general health and activity level rated at 2 or lower on a standard medical scale (meaning they are able to care for themselves, even if not able to do heavy physical work).
- For Modules 1 and 2 – the person must be expected to live for at least 8 weeks.
Who may not be able to join:
- People diagnosed with Burkitt lymphoma/leukaemia or a specific type of leukaemia called Acute Promyelocytic Leukaemia.
- People whose leukaemia has spread to the testicles or to the brain and spinal cord in an active way.
- People who still have side effects rated moderate or severe (Grade 2 or higher) from a previous cancer treatment that have not yet resolved.
- People with abnormal potassium or magnesium levels in their blood before starting the study drug.
- For Module 1 – people who have had radiation therapy (outside the brain and spinal cord) within the past 2 weeks, or radiation to the brain and spinal cord within the past 8 weeks.
- For Module 1 – people who have recently received any other cancer treatment, whether experimental or standard, including prior use of a type of drug called a menin inhibitor (this restriction on menin inhibitors applies to the backfill group only).
- For Module 1 (food effect sub-study only) – people with Type 1 or Type 2 diabetes.
- For Module 2 – people who have received any other cancer treatment (experimental or standard) or any radiation therapy.
- For Module 2 – people for whom a specific antifungal medicine called posaconazole is not recommended or not safe to use according to local prescribing guidelines.
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: 1-877-240-9479
Australian sites
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
Where this trial is recruiting
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Module 1: Number of participants with dose-limiting toxicity (DLT); Module 1 and Module 2: Number of participants with dose modification, delay and discontinuations due to adverse events (AEs); Module 1 and Module 2: Number of participants with treatment-emergent adverse events (TEAEs), treatment-related AEs (TRAEs) and serious adverse vents (SAEs)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 12 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.