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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

Full criteria on ClinicalTrials.gov

Sites (47)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Monash Health
Coordinator of this site? Confirm its status
ClaytonAustraliaRecruiting
Concord Repatriation General Hospital
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ConcordAustraliaRecruiting
St Vincents Hospital Melbourne
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FitzroyAustraliaRecruiting
Austin Health
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HeidelbergAustraliaRecruiting
St George Hospital
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KogarahAustraliaRecruiting
The Alfred Hospital
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MelbourneAustraliaRecruiting
Fiona Stanley Hospital
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MurdochAustraliaRecruiting
One Clinical Research
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NedlandsAustraliaRecruiting
Linear Clinical Research
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NedlandsAustraliaRecruiting
Orange Health Hospital
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OrangeAustraliaRecruiting
Gold Coast University Hospital
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SouthportAustraliaRecruiting
Peking University Peoples Hospital
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BeijingChinaRecruiting
West China Hospital,Sichuan University
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ChengduChinaRecruiting
Nanfang Hospital, Southern Medical University
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GuangzhouChinaRecruiting
Guangdong Provincial Peoples Hospital
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GuangzhouChinaRecruiting
The First Affiliated Hospital Zhejiang University School of Medicine
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HangzhouChinaRecruiting
The First Hospital of Lanzhou University
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LanzhouChinaRecruiting
The First Affiliated Hospital of Nanchang University Branch Donghu
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NanchangChinaRecruiting
The Second Peoples Hospital of Shenzhen
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ShenzhenChinaCompleted
The First Affiliated Hospital of Soochow University
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SuzhouChinaRecruiting
Tianjin Medical University Cancer Institute and Hospital
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TianjinChinaCompleted
Union Hospital of Tongji Medical College Huazhong University of Science and Technology
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WuhanChinaRecruiting
Henan Cancer Hospital
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ZhengzhouChinaRecruiting
Universitaet Leipzig
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LeipzigGermanyRecruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyRecruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
Hospital Universitario De Salamanca
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SalamancaSpainRecruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainRecruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainRecruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceRecruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Edinburgh Cancer Centre
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EdinburghUnited KingdomActive, not recruiting
The Christie Hospital
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Greater ManchesterUnited KingdomActive, not recruiting
Azienda Unita Sanitaria Locale Di Bologna
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BolognaItalyRecruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
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MeldolaItalyRecruiting
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyRecruiting
Samsung Medical Center
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GangnamGuSouth KoreaRecruiting
Severance Hospital Yonsei University Health System
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SeodaemunGuSouth KoreaRecruiting
Aotearoa Clinical Trials
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AucklandNew ZealandRecruiting
North Shore Hospital
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AucklandNew ZealandRecruiting
Wellington Regional Hospital (Ccdhb)
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WellingtonNew ZealandRecruiting
City of Hope National Medical Center
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DuarteUnited StatesTerminated
MD Anderson Cancer Center
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HoustonUnited StatesRecruiting
Medical College of Wisconsin
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MilwaukeeUnited StatesRecruiting
Upmc Hillman Cancer Center(Univ of Pittsburgh)
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PittsburghUnited StatesRecruiting
Tampa General Hospital
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TampaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.