Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT04771130

A Study of BGB-11417 in Participants With Myeloid Malignancies

Led by BeiGene · Updated on 2026-04-23

260

Participants Needed

46

Research Sites

350 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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) .

CONDITIONS

Official Title

A Study of BGB-11417 in Participants With Myeloid Malignancies

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of AML (nonacute promyelocytic leukemia), MDS, or MDS/MPN by 2016 WHO criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Adequate organ function including creatinine clearance  50 mL/min (or 30-49 mL/min in unfit AML cohort)
  • Adequate liver function
  • Life expectancy greater than 12 weeks
  • Ability to comply with study requirements
Not Eligible

You will not qualify if you...

  • Diagnosis of acute promyelocytic leukemia
  • History of prior malignancy except MDS or MDS/MPN transformed to AML, or other prior malignancy treated with curative intent and no recurrence for 2 years
  • Antecedent myeloproliferative neoplasm including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation, and AML with BCR-ABL1 translocation
  • Prior treatment with a B-cell lymphoma-2 inhibitor
  • Known central nervous system involvement by leukemia
  • Other protocol-defined exclusion criteria may apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

B

BeiGene

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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