Phase 2 study for people with Leukaemia

Recruiting Phase 2

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

This trial at a glance

Status Recruiting
Phase Phase 2
Sponsor BeOne Medicines
Registry number NCT04771130
Started 24 May 2021 Today 16 October 2026 Estimated completion 31 August 2028

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Concord Repatriation General Hospital Concord NSW Recruiting
St George Hospital Kogarah NSW Recruiting
Orange Health Hospital Orange NSW Recruiting
Gold Coast University Hospital Southport QLD Recruiting
Monash Health Clayton VIC Recruiting
St Vincents Hospital Melbourne Fitzroy VIC Recruiting
Austin Health Heidelberg VIC Recruiting
The Alfred Hospital Melbourne VIC Recruiting
Fiona Stanley Hospital Murdoch WA Recruiting
Linear Clinical Research Nedlands WA Recruiting
One Clinical Research Nedlands WA 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 260

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:

1. Confirmed diagnosis of one of the following by 2016 World Health Organization criteria:

* AML, nonacute promyelocytic leukemia

* MDS

* MDS/MPN

2. Eastern Cooperative Oncology Group performance status of 0 to 2.

3. Adequate organ function defined as:

* Creatinine clearance ≥ 50 milliliters/minute (mL/min) (or between 30 and 49 mL/min in unfit AML cohort)

* Adequate liver function

4. Life expectancy of \> 12 weeks.

5. Ability to comply with the requirements of the study.

Key Exclusion Criteria:

1. A diagnosis of acute promyelocytic leukemia.

2. History of prior malignancy, with the exception of either a history of MDS or MDS/MPN that has transformed to AML, or other prior malignancy that was treated with a full curative intent and no evidence of recurrence within the past 2 years (eg, localized skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer)

3. Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.

4. Prior therapy with a B-cell lymphoma-2 inhibitor

5. Known central nervous system involvement by leukemia.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Dates on the record

Started 24 May 2021
Estimated completion 31 August 2028
Registry last updated 14 September 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: 14 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.