Actively Recruiting
A Phase 1b/2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients With Myeloid Malignancies
Led by BeiGene · Updated on 2026-04-23
260
Participants Needed
46
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, best dose, and early effectiveness of the drug BGB-11417 alone and combined with azacitidine in adults diagnosed with acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or MDS/myeloproliferative neoplasm (MPN). The study aims to find the recommended Phase 2 dose and assess treatment effects in these myeloid malignancies. This is an open-label Phase 1b/2 clinical trial sponsored by BeiGene.
CONDITIONS
Brief Title
A Study of BGB-11417 in Participants With Myeloid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of AML (nonacute promyelocytic leukemia), MDS, or MDS/MPN by 2016 WHO criteria
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Adequate kidney function with creatinine clearance 250 mL/min (or 30 to 49 mL/min for unfit AML patients)
- Adequate liver function
- Life expectancy greater than 12 weeks
- Ability to comply with study requirements
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia
- History of prior malignancy except specific cases treated with curative intent and no recurrence within 2 years
- Antecedent myeloproliferative neoplasm including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation
- AML with BCR-ABL1 translocation
- Prior therapy with a B-cell lymphoma-2 inhibitor
- Known central nervous system involvement by leukemia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive oral BGB-11417 and azacitidine on a 28-day cycle. Some participants may receive posaconazole orally for 8 days during the second cycle to explore drug interactions. A subset of participants with MDS and R/R AML may receive BGB-11417 monotherapy on a 28-day cycle.
Visits occur each cycle with drug administration on specified days within the 28-day cycle
Duration - Up to 24 months
Participants are monitored for safety and treatment outcomes for up to approximately 24 months after treatment.
Periodic visits for up to 24 months
Trial Site Locations
Total: 46 locations
1
City of Hope National Medical Center
Duarte, California, United States, 91010-3012
Terminated
2
Tampa General Hospital
Tampa, Florida, United States, 33606-3571
Actively Recruiting
3
Upmc Hillman Cancer Center(Univ of Pittsburgh)
Pittsburgh, Pennsylvania, United States, 15232-1309
Actively Recruiting
4
Md Anderson Cancer Center
Houston, Texas, United States, 77030-3907
Actively Recruiting
5
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226-1222
Actively Recruiting
6
Concord Repatriation General Hospital
Concord, New South Wales, Australia, NSW 2139
Actively Recruiting
7
St George Hospital
Kogarah, New South Wales, Australia, NSW 2217
Actively Recruiting
8
Orange Health Hospital
Orange, New South Wales, Australia, NSW 2800
Actively Recruiting
9
Gold Coast University Hospital
Southport, Queensland, Australia, QLD 4215
Actively Recruiting
10
Monash Health
Clayton, Victoria, Australia, VIC 3168
Actively Recruiting
11
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia, VIC 3065
Actively Recruiting
12
Austin Health
Heidelberg, Victoria, Australia, VIC 3084
Actively Recruiting
13
The Alfred Hospital
Melbourne, Victoria, Australia, VIC 3004
Actively Recruiting
14
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, WA 6150
Actively Recruiting
15
Linear Clinical Research
Nedlands, Western Australia, Australia, WA 6009
Actively Recruiting
16
One Clinical Research
Nedlands, Western Australia, Australia, WA 6009
Actively Recruiting
17
Peking University Peoples Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
18
The First Hospital of Lanzhou University
Lanzhou, Gansu, China, 730000
Actively Recruiting
19
Guangdong Provincial Peoples Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
20
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
21
The Second Peoples Hospital of Shenzhen
Shenzhen, Guangdong, China, 518037
Completed
22
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
23
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
24
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
25
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China, 330006
Actively Recruiting
26
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
27
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060
Completed
28
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
29
Hopital Claude Huriez Chu Lille
Lille, France, 59000
Actively Recruiting
30
Hopital Larchet
Nice, France, 06200
Actively Recruiting
31
Hopital Saint Louis
Paris, France, 75010
Actively Recruiting
32
Universitaetsklinikum Leipzig Aor
Leipzig, Germany, 04103
Actively Recruiting
33
Universitaetsklinikum Ulm
Ulm, Germany, 89081
Actively Recruiting
34
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna, Italy, 40138
Actively Recruiting
35
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
Meldola, Italy, 47014
Actively Recruiting
36
Niguarda Cancer Center Division of Hematology
Milan, Italy, 20162
Actively Recruiting
37
North Shore Hospital
Auckland, New Zealand, 0622
Actively Recruiting
38
Wellington Regional Hospital (Ccdhb)
Wellington, New Zealand, 6021
Actively Recruiting
39
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea, 06351
Actively Recruiting
40
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722
Actively Recruiting
41
Hospital de La Santa Creu I Sant Pau
Barcelona, Spain, 08041
Actively Recruiting
42
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Actively Recruiting
43
Hospital Universitario Virgen Del Rocio
Seville, Spain, 41013
Actively Recruiting
44
Hospital Universitari I Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
45
Edinburgh Cancer Centre
Edinburgh, United Kingdom, EH4 2XU
Actively Recruiting
46
The Christie Hospital
Greater Manchester, United Kingdom, M20 4BX
Actively Recruiting
Research Team
B
BeiGene
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here