Phase 3 study for people with Leukaemia
Recruiting Phase 3
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Clinical Trial Site | Kingswood | NSW | Recruiting |
| Clinical Trial Site | Kogarah | NSW | Recruiting |
| Clinical Trial Site | Randwick | NSW | Recruiting |
| Clinical Trial Site | South Brisbane | QLD | Recruiting |
| Clinical Trial Site | Melbourne | VIC | Recruiting |
| Clinical Trial Site | Nedlands | WA | Recruiting |
| Clinical Trial Site | Perth | WA | Recruiting |
| Clinical Trial Site | Gosford | NSW | Recruiting |
| Clinical Trial Site | Wollongong | NSW | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
Key Inclusion Criteria:
* Participants must have newly diagnosed and previously untreated AML and be candidates for intensive chemotherapy.
* Presence of an NPM1 mutation.
* Eastern Cooperative Oncology Group performance status ≤2 (≤1 if \>65 years old); Karnofsky or Lansky ≥40.
* Have a life expectancy of ≥3 months as judged by the Investigator.
* Negative serum pregnancy test.
* Adequate liver, kidney, and cardiac function.
Key Exclusion Criteria:
* Diagnosis of active acute promyelocytic leukemia.
* Active central nervous system disease.
* Fridericia's corrected QT interval (QTcF) \>450 milliseconds at screening, diagnosis or suspicion of Long QT syndrome or family history of Long QT syndrome.
* Any gastrointestinal (GI) issue of the upper GI tract likely to affect oral drug absorption or ingestion.
* Any concurrent malignancy requiring active therapy (except breast or prostate cancer stable on or responding to endocrine therapy).
* Inability to swallow oral medication.
* Pregnant or nursing females.
* Participant has known active or chronic hepatitis B or active hepatitis C (HCV) infection or human immunodeficiency virus (HIV)-positive with detectable viral load.
Note: Additional inclusion/exclusion criteria may apply, per protocol.
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 25 September 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.