Phase 3 study for people with Leukaemia

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor Ascentage Pharma Group Inc.
Registry number NCT06051409
Started 31 August 2023 Today 16 October 2026 Estimated completion 31 December 2027

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Royal North Shore Hospital St Leonards NSW Active not recruiting
Royal Adelaide Hospital Adelaide SA Active not recruiting
Alfred Health Melbourne VIC Active not recruiting
Royal Perth Hospital Perth WA Active not recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 350

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 Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL)

2. Expected survival of at least 3 months

3. ECOG ≤ 2

4. Adequate organ function

Exclusion Criteria:

1. A history of chronic myeloid leukemia (CML)

2. Clinical manifestations of central nervous system (CNS) leukemia or ALL extramedullary infiltration, except lymphadenopathy or hepatosplenomegaly

3. Previous or current clinical CNS diseases

4. Autoimmune diseases that may involve the CNS

5. Use of therapeutic doses of anticoagulants and/or antiplatelet agents; low doses of anticoagulants or antiplatelet agents are allowed

6. Use a therapeutic drug that has drug interaction with the investigational drug due to other diseases within 7 days or within 5 half-lives (whichever is shorter) prior to the first receipt of the investigational drug

7. Uncontrolled heart diseases

8. Any venous thromboembolism in the 6 months prior to randomization, including but not limited to deep vein thrombosis (DVT) or pulmonary embolism

9. Use of prohibited drugs

10. Disease or medical condition that is unstable or may affect its safety or compliance with the study

11. Use of medications known to cause prolonged QT interval

12. Active infections requiring systemic treatment

13. Disease that severely affects the oral administration and absorption of drugs, or an active gastrointestinal ulcer

14. Contraindications to the use of glucocorticoids

15. Bleeding disorders unrelated to ALL

16. Plan to undergo major surgery

17. Allergy to drug ingredients, excipients, or their analogues in the study

18. Female subjects who are pregnant or breastfeeding or expect to become pregnant during the study period

19. Other malignant tumors within 2 years

20. Any symptom or illness that may interfere with the evaluation of the efficacy and safety of the investigational drug, or any other condition or condition that is not appropriate for participation in the study

Dates on the record

Started 31 August 2023
Estimated completion 31 December 2027
Registry last updated 30 April 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 30 April 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.