Printed from Voxsanity (voxsanity.com.au) — NCT04771130 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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:
People who have been diagnosed with Acute Myeloid Leukemia (AML, but not a specific type called acute promyelocytic leukemia), a bone marrow condition called Myelodysplastic Syndrome (MDS), or a combined bone marrow condition called MDS/MPN, confirmed using 2016 World Health Organization standards.
People whose general physical health and ability to carry out daily activities falls within a certain acceptable range, as measured by a standard medical scoring system (scores 0 to 2 on the ECOG scale — confirm with trial site).
People whose kidneys and liver are functioning at an adequate level, as measured by specific medical tests (confirm with trial site for exact values).
People whose life expectancy is estimated to be greater than 12 weeks.
People who are able to follow all the requirements of the study.
Who may not be able to join:
People who have been diagnosed with a specific type of leukemia called acute promyelocytic leukemia.
People who have a history of another cancer, unless that cancer was MDS or MDS/MPN that later developed into AML, or unless that other cancer was fully treated with the aim of a cure and there has been no sign of it returning in the past two years (for example, certain skin cancers, superficial bladder cancer, early-stage cervical or breast conditions, or a low-grade prostate cancer).
People whose AML developed from certain other bone marrow disorders, including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia, or people whose AML involves a specific genetic change called BCR-ABL1.
People who have previously been treated with a type of drug known as a BCR-2 inhibitor (a targeted cancer medicine — confirm exact drug history with trial site).
People whose leukemia has spread to the central nervous system (the brain and spinal cord).
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.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 14 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.
Contact this trial
Principal Investigator: Study Director, BeOne Medicines
Concord Repatriation General Hospital, Concord, New South Wales
St George Hospital, Kogarah, New South Wales
Orange Health Hospital, Orange, New South Wales
Gold Coast University Hospital, Southport, Queensland
Monash Health, Clayton, Victoria
St Vincents Hospital Melbourne, Fitzroy, Victoria
Austin Health, Heidelberg, Victoria
The Alfred Hospital, Melbourne, Victoria
Fiona Stanley Hospital, Murdoch, Western Australia
Linear Clinical Research, Nedlands, Western Australia
One Clinical Research, Nedlands, Western Australia
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.
Voxsanity
Clinical trials and treatments, explained plainly · voxsanity.com.au
Date:
To: My Doctor
Re: Clinical trial enquiry
I am writing to enquire about the following clinical trial which may be relevant to my care:
Trial: NCT04771130
Sponsor: BeOne Medicines
Phase: Phase 2
Status: Recruiting
Condition: Leukaemia
Trial contact: 1.877.828.5568
More information: https://clinicaltrials.gov/study/NCT04771130
Eligibility summary (AI generated)
Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.
Who might be able to join this trial:
People who have been diagnosed with Acute Myeloid Leukemia (AML, but not a specific type called acute promyelocytic leukemia), a bone marrow condition called Myelodysplastic Syndrome (MDS), or a combined bone marrow condition called MDS/MPN, confirmed using 2016 World Health Organization standards.
People whose general physical health and ability to carry out daily activities falls within a certain acceptable range, as measured by a standard medical scoring system (scores 0 to 2 on the ECOG scale — confirm with trial site).
People whose kidneys and liver are functioning at an adequate level, as measured by specific medical tests (confirm with trial site for exact values).
People whose life expectancy is estimated to be greater than 12 weeks.
People who are able to follow all the requirements of the study.
Who may not be able to join:
People who have been diagnosed with a specific type of leukemia called acute promyelocytic leukemia.
People who have a history of another cancer, unless that cancer was MDS or MDS/MPN that later developed into AML, or unless that other cancer was fully treated with the aim of a cure and there has been no sign of it returning in the past two years (for example, certain skin cancers, superficial bladder cancer, early-stage cervical or breast conditions, or a low-grade prostate cancer).
People whose AML developed from certain other bone marrow disorders, including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia, or people whose AML involves a specific genetic change called BCR-ABL1.
People who have previously been treated with a type of drug known as a BCR-2 inhibitor (a targeted cancer medicine — confirm exact drug history with trial site).
People whose leukemia has spread to the central nervous system (the brain and spinal cord).
Important: Always verify eligibility with the trial site directly before applying.
Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.
This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 14 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.
Trial details
Status
Recruiting
Phase
Phase 2
Sponsor
BeOne Medicines
Registry
ClinicalTrials.gov
Start date
24 May 2021
Est. completion
8 February 2028
Where this trial is recruiting
🇦🇺 Australia
🇨🇳 China
🇫🇷 France
🇩🇪 Germany
🇮🇹 Italy
🇳🇿 New Zealand
🇰🇷 South Korea
🇪🇸 Spain
🇬🇧 United Kingdom
🇺🇸 United States
11 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Part 1 And 2: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs); Part 1 And 2: Number Of Participants Experiencing Treatment-emergent Adverse Events (TEAEs); Part 3 AML Cohort: Complete Remission (CR) Plus CR With Partial Hematologic Recovery (CRh) Rate; Part 3 MDS Cohort: Modified Overall Response (mOR) Rate; Part 3 AML Cohort (DDI Sub-cohort): Area Under Plasma Concentration-time Curve (AUC) from time 0 to the last quantifiable timepoint (t) (AUC0-t) Of BGB-11417 When Administered Alone and when Co-administered With Posaconazole; Part 3 AML Cohort (DDI Sub-cohort): Maximum...
Can't join this trial?
Expanded access pathways
If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.
Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.