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NCT04771130PHASE1, PHASE2Recruiting

A Study of BGB-11417 in Participants With Myeloid Malignancies

BeOne Medicines

Start Date

5/24/2021

Completion Date

2/8/2028

Summary

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) .

Detailed Description

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

BGB-11417

DRUG

Azacitidine

DRUG

Posaconazole

DRUG

BGB-11417

DRUG

BGB-11417

Interested in This Trial?

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Conditions

Acute Myeloid LeukemiaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Neoplasm

Locations

City of Hope National Medical Center

Duarte, California 91010-3012

United States

Tampa General Hospital

Tampa, Florida 33606-3571

United States

Upmc Hillman Cancer Center(Univ of Pittsburgh)

Pittsburgh, Pennsylvania 15232-1309

United States

Md Anderson Cancer Center

Houston, Texas 77030-3907

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226-3522

United States

Concord Repatriation General Hospital

Concord, New South Wales NSW 2139

Australia

St George Hospital

Kogarah, New South Wales NSW 2217

Australia

Orange Health Hospital

Orange, New South Wales NSW 2800

Australia

Gold Coast University Hospital

Southport, Queensland QLD 4215

Australia

Monash Health

Clayton, Victoria VIC 3168

Australia

St Vincents Hospital Melbourne

Fitzroy, Victoria VIC 3065

Australia

Austin Health

Heidelberg, Victoria VIC 3084

Australia

The Alfred Hospital

Melbourne, Victoria VIC 3004

Australia

Fiona Stanley Hospital

Murdoch, Western Australia WA 6150

Australia

Linear Clinical Research

Nedlands, Western Australia WA 6009

Australia

One Clinical Research

Nedlands, Western Australia WA 6009

Australia

Peking University Peoples Hospital

Beijing, Beijing Municipality 100044

China

The First Hospital of Lanzhou University

Lanzhou, Gansu 730000

China

Guangdong Provincial Peoples Hospital

Guangzhou, Guangdong 510080

China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong 510515

China

The Second Peoples Hospital of Shenzhen

Shenzhen, Guangdong 518037

China

Henan Cancer Hospital

Zhengzhou, Henan 450000

China

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei 430022

China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu 215006

China

The First Affiliated Hospital of Nanchang University Branch Donghu

Nanchang, Jiangxi 330006

China

West China Hospital, Sichuan University

Chengdu, Sichuan 610041

China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality 300060

China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang 310003

China

Hopital Claude Huriez Chu Lille

Lille, 59000

France

Hopital Larchet

Nice, 06200

France

Hopital Saint Louis

Paris, 75010

France

Universitaetsklinikum Leipzig Aor

Leipzig, 04103

Germany

Universitaetsklinikum Ulm

Ulm, 89081

Germany

Policlinico Sorsola Malpighi, Aou Di Bologna

Bologna, 40138

Italy

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst

Meldola, 47014

Italy

Niguarda Cancer Center Division of Hematology

Milan, 20162

Italy

North Shore Hospital

Auckland, 0622

New Zealand

Wellington Regional Hospital (Ccdhb)

Wellington, 6021

New Zealand

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi 06351

South Korea

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi 03722

South Korea

Hospital de La Santa Creu I Sant Pau

Barcelona, 08041

Spain

Hospital Universitario de Salamanca

Salamanca, 37007

Spain

Hospital Universitario Virgen Del Rocio

Seville, 41013

Spain

Hospital Universitari I Politecnic La Fe

Valencia, 46026

Spain

Edinburgh Cancer Centre

Edinburgh, EH4 2XU

United Kingdom

The Christie Hospital

Greater Manchester, M20 4BX

United Kingdom