Phase 3 study for people with Leukaemia

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 15 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor Ascentage Pharma Group Inc.
Registry number NCT06641414
Started 22 January 2025 Today 16 October 2026 Estimated completion 1 June 2029

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Ascentage Investigative Site Blacktown NSW Recruiting
Ascentage Investigative Site Cooloongup WA Recruiting
Ascentage Investigative Site Epping VIC Recruiting
Ascentage Investigative Site Heidelberg VIC Recruiting
Ascentage Investigative Site Kingswood NSW Recruiting
Ascentage Investigative Site Liverpool NSW Not yet recruiting
Ascentage Investigative Site Melbourne VIC Recruiting
Ascentage Investigative Site Perth WA Recruiting
Ascentage Investigative Site Richmond VIC Recruiting
Ascentage Investigative Site Waratah NSW Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 15 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 490

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.

Inclusion Criteria:

1. Newly diagnosed higher-risk MDS.

2. ECOG score of ≤2.

3. Expected survival ≥ 3 months.

4. Adequate organ function.

5. Female subjects of potential childbearing potential have a negative urine or serum pregnancy test before dosing. Subjects of childbearing potential as well as their partners voluntarily use contraception deemed effective by the investigator during the treatment period and for at least six months after the last dose of study drug.

6. Able to understand and voluntarily sign a written informed consent form, which must be signed prior to the performance of any trial-specified study procedures.

7. Subjects are able to complete study procedures and follow-up examinations.

Exclusion Criteria:

1. Concomitant other malignancies or prior malignancies with disease-free intervals of less than 1 year at the time of signing the informed consent.

2. Have undergone hematopoietic stem cell transplantation.

3. Use of moderately potent inducers and moderately potent inhibitors of CYP3A4 within 14 days prior to the first dose of study drug.

4. MDS or other conditions that cannot be administered enterally.

5. Any condition that the subject is deemed to be inappropriate to participate in this study after evaluation by the investigator.

Dates on the record

Started 22 January 2025
Estimated completion 1 June 2029
Registry last updated 13 October 2026
Checked by Voxsanity 15 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 13 October 2026.
  • This page last checked by Voxsanity: 15 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.