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A Study of BGB-11417 in Participants With Myeloid Malignancies
NCT04771130 · BeOne Medicines
In plain English
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Official title
A Phase 1b/2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients With Myeloid Malignancies
About this study
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) .
Eligibility criteria
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.
Study design
Enrollment target: 260 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-05-24
Estimated completion: 2028-02-08
Last updated: 2026-04-14
Interventions
Drug: BGB-11417Drug: AzacitidineDrug: PosaconazoleDrug: BGB-11417Drug: BGB-11417
Primary outcomes
- • Part 1 And 2: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs) (Cycle 1 (Up to 28 days for non-hematologic DLTs and up to 42 days for hematologic DLTs))
- • Part 1 And 2: Number Of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) (Approximately 24 months)
- • Part 3 AML Cohort: Complete Remission (CR) Plus CR With Partial Hematologic Recovery (CRh) Rate (Approximately 24 months)
Sponsor
BeiGene · industry
Contacts & investigators
ContactBeiGene · contact · clinicaltrials@beigene.com · 1.877.828.5568
All locations (46)
City of Hope National Medical CenterTerminated
Duarte, California, United States
Tampa General HospitalRecruiting
Tampa, Florida, United States
Upmc Hillman Cancer Center(Univ of Pittsburgh)Recruiting
Pittsburgh, Pennsylvania, United States
Md Anderson Cancer CenterRecruiting
Houston, Texas, United States
Medical College of WisconsinRecruiting
Milwaukee, Wisconsin, United States
Concord Repatriation General HospitalRecruiting
Concord, New South Wales, Australia
St George HospitalRecruiting
Kogarah, New South Wales, Australia
Orange Health HospitalRecruiting
Orange, New South Wales, Australia
Gold Coast University HospitalRecruiting
Southport, Queensland, Australia
Monash HealthRecruiting
Clayton, Victoria, Australia
St Vincents Hospital MelbourneRecruiting
Fitzroy, Victoria, Australia
Austin HealthRecruiting
Heidelberg, Victoria, Australia
The Alfred HospitalRecruiting
Melbourne, Victoria, Australia
Fiona Stanley HospitalRecruiting
Murdoch, Western Australia, Australia
Linear Clinical ResearchRecruiting
Nedlands, Western Australia, Australia
One Clinical ResearchRecruiting
Nedlands, Western Australia, Australia
Peking University Peoples HospitalRecruiting
Beijing, Beijing Municipality, China
The First Hospital of Lanzhou UniversityRecruiting
Lanzhou, Gansu, China
Guangdong Provincial Peoples HospitalRecruiting
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical UniversityRecruiting
Guangzhou, Guangdong, China
The Second Peoples Hospital of ShenzhenCompleted
Shenzhen, Guangdong, China
Henan Cancer HospitalRecruiting
Zhengzhou, Henan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
Wuhan, Hubei, China
The First Affiliated Hospital of Soochow UniversityRecruiting
Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University Branch DonghuRecruiting
Nanchang, Jiangxi, China
West China Hospital, Sichuan UniversityRecruiting
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and HospitalCompleted
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of MedicineRecruiting
Hangzhou, Zhejiang, China
Hopital Claude Huriez Chu LilleRecruiting
Lille, France
Hopital LarchetRecruiting
Nice, France
Hopital Saint LouisRecruiting
Paris, France
Universitaetsklinikum Leipzig AorRecruiting
Leipzig, Germany
Universitaetsklinikum UlmRecruiting
Ulm, Germany
Policlinico Sorsola Malpighi, Aou Di BolognaRecruiting
Bologna, Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IrstRecruiting
Meldola, Italy
Niguarda Cancer Center Division of HematologyRecruiting
Milan, Italy
North Shore HospitalRecruiting
Auckland, New Zealand
Wellington Regional Hospital (Ccdhb)Recruiting
Wellington, New Zealand
Samsung Medical CenterRecruiting
GangnamGu, Seoul Teugbyeolsi, South Korea
Severance Hospital Yonsei University Health SystemRecruiting
SeodaemunGu, Seoul Teugbyeolsi, South Korea
Hospital de La Santa Creu I Sant PauRecruiting
Barcelona, Spain
Hospital Universitario de SalamancaRecruiting
Salamanca, Spain
Hospital Universitario Virgen Del RocioRecruiting
Seville, Spain
Hospital Universitari I Politecnic La FeRecruiting
Valencia, Spain
Edinburgh Cancer CentreRecruiting
Edinburgh, United Kingdom
The Christie HospitalRecruiting
Greater Manchester, United Kingdom