NCT04771130RecruitingPhase 1/2
A Study of BGB-11417 in Participants With Myeloid Malignancies
A Phase 1b/2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients With Myeloid Malignancies
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
The study will determine the safety, tolerability, recommended Phase 2 dose (RP2D) and preliminary efficacy of BGB-11417 as monotherapy and in combination with azacitidine in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)or MDS/myeloproliferative neoplasm (MPN) .
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 260 (estimated)
- First submitted
- 23 Feb 2021
- Start date
- 24 May 2021
- Primary completion date
- 31 Aug 2028
- Lead sponsor
- BeOne Medicines
- NCT number
- NCT04771130
- EU CT number
- 2023-508881-14-00
- EudraCT number
- 2021-003285-12
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 260
- From 24 May 2021 to the primary completion date, 31 Aug 2028
- 47 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior therapy with a B-cell lymphoma-2 inhibitor
Other illness
- 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)
Other
- A diagnosis of acute promyelocytic leukemia.
- Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.
- Known central nervous system involvement by leukemia.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Who the study is looking for
- Confirmed diagnosis of one of the following by 2016 World Health Organization criteria:
- AML, nonacute promyelocytic leukemia
- MDS
- MDS/MPN
- Eastern Cooperative Oncology Group performance status of 0 to 2.
- 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
- Life expectancy of \> 12 weeks.
- Ability to comply with the requirements of the study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (47)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Monash Health Coordinator of this site? Confirm its status | Clayton | Australia | Recruiting |
| Concord Repatriation General Hospital Coordinator of this site? Confirm its status | Concord | Australia | Recruiting |
| St Vincents Hospital Melbourne Coordinator of this site? Confirm its status | Fitzroy | Australia | Recruiting |
| Austin Health Coordinator of this site? Confirm its status | Heidelberg | Australia | Recruiting |
| St George Hospital Coordinator of this site? Confirm its status | Kogarah | Australia | Recruiting |
| The Alfred Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Fiona Stanley Hospital Coordinator of this site? Confirm its status | Murdoch | Australia | Recruiting |
| One Clinical Research Coordinator of this site? Confirm its status | Nedlands | Australia | Recruiting |
| Linear Clinical Research Coordinator of this site? Confirm its status | Nedlands | Australia | Recruiting |
| Orange Health Hospital Coordinator of this site? Confirm its status | Orange | Australia | Recruiting |
| Gold Coast University Hospital Coordinator of this site? Confirm its status | Southport | Australia | Recruiting |
| Peking University Peoples Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Guangdong Provincial Peoples Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The First Hospital of Lanzhou University Coordinator of this site? Confirm its status | Lanzhou | China | Recruiting |
| The First Affiliated Hospital of Nanchang University Branch Donghu Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| The Second Peoples Hospital of Shenzhen Coordinator of this site? Confirm its status | Shenzhen | China | Completed |
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| Tianjin Medical University Cancer Institute and Hospital Coordinator of this site? Confirm its status | Tianjin | China | Completed |
| Union Hospital of Tongji Medical College Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| Universitaet Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Edinburgh Cancer Centre Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Active, not recruiting |
| The Christie Hospital Coordinator of this site? Confirm its status | Greater Manchester | United Kingdom | Active, not recruiting |
| Azienda Unita Sanitaria Locale Di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l Coordinator of this site? Confirm its status | Meldola | Italy | Recruiting |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | GangnamGu | South Korea | Recruiting |
| Severance Hospital Yonsei University Health System Coordinator of this site? Confirm its status | SeodaemunGu | South Korea | Recruiting |
| Aotearoa Clinical Trials Coordinator of this site? Confirm its status | Auckland | New Zealand | Recruiting |
| North Shore Hospital Coordinator of this site? Confirm its status | Auckland | New Zealand | Recruiting |
| Wellington Regional Hospital (Ccdhb) Coordinator of this site? Confirm its status | Wellington | New Zealand | Recruiting |
| City of Hope National Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Terminated |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| Upmc Hillman Cancer Center(Univ of Pittsburgh) Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Tampa General Hospital Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.