Chronic Lymphocytic Leukemia Clinical Trial

A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia

Summary

This study is designed to compare the overall response rate of zanubrutinib versus ibrutinib in participants with relapsed/refractory leukemia-cll/" >chronic lymphocytic leukemia or small lymphocytic lymphoma.

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Full Description

This is a global, Phase 3, randomized study of zanubrutinib versus ibrutinib in approximately 600 participants with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

The primary efficacy endpoint is overall response rate determined by investigator assessment. Participants will be randomized in a 1:1 manner to either zanubrutinib or ibrutinib. Treatment with zanubrutinib and ibrutinib will be open label.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria

Confirmed diagnosis of CLL or SLL that meets the 2008 IWCLL criteria
CLL/SLL requiring treatment per 2008 IWCLL criteria
Relapsed or refractory to at least 1 prior systemic therapy for CLL/SLL
Measurable disease by CT/magnetic resonance imaging (MRI)
ECOG performance status of 0, 1, or 2
Life expectancy ≥ 6 months
Adequate bone marrow function
Adequate renal and hepatic function

Key Exclusion Criteria

Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
Clinically significant cardiovascular disease.
Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix or breast
History of severe bleeding disorder or history of spontaneous bleeding requiring blood transfusion or other medical intervention
History of stroke or intracranial hemorrhage within 180 days before first dose of study drug
Severe or debilitating pulmonary disease
Active fungal, bacterial, and/or viral infection requiring systemic therapy
Known central nervous system involvement by leukemia or lymphoma
Known infection with HIV or active viral hepatitis B or C infection
Moderate or severe hepatic impairment, ie, Child-Pugh class B or C
Major surgery within 4 weeks of the first dose of study drug
Prior treatment with a BTK inhibitor
Toxicity from prior anticancer therapy that has not recovered to ≤ Grade 1
Pregnant or lactating women
Vaccination with a live vaccine within 35 days prior to the first dose of study drug
Hypersensitivity to zanubrutinib, ibrutinib, or any of the other ingredients in either drug
Concurrent participation in another therapeutic clinical trial

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

652

Study ID:

NCT03734016

Recruitment Status:

Active, not recruiting

Sponsor:

BeiGene

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There are 78 Locations for this study

See Locations Near You

CARTI Cancer Center
Little Rock Arkansas, 72205, United States
David Geffen School of Medicine at UCLA
Los Angeles California, 90095, United States
University of California Irvine Medical Center
Orange California, 92868, United States
Rocky Mountain Cancer Centers (Aurora) - USOR
Aurora Colorado, 80012, United States
SCRI Florida Cancer Specialists South
Fort Myers Florida, 33909, United States
SCRI Florida Cancer Specialists North
Saint Petersburg Florida, 33705, United States
Augusta University
Augusta Georgia, 30912, United States
Illinois Cancer Specialists (Niles) - USOR
Niles Illinois, 60714, United States
Norton Cancer Institute - Pavilion
Louisville Kentucky, 40202, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Hattiesburg Hematology and Oncology Clinic
Hattiesburg Mississippi, 39401, United States
Central Care Cancer Center
Bolivar Missouri, 65613, United States
SCRI HCA Midwest Health
Kansas City Missouri, 66211, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
Comprehensive Cancer Centers of Nevada - USOR
Las Vegas Nevada, 89169, United States
New Jersey Hematology Oncology Associates LLC
Brick New Jersey, 08724, United States
Summit Medical Group
Florham Park New Jersey, 07932, United States
Atlantic Health System
Morristown New Jersey, 07960, United States
Clinical Research Alliance Inc
Lake Success New York, 11042, United States
Columbia University Medical Center
New York New York, 10032, United States
Duke University Medical Center
Durham North Carolina, 27705, United States
Leo W. Jenkins Cancer Center
Greenville North Carolina, 27834, United States
Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States
Willamette Valley Cancer Center
Eugene Oregon, 97401, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Greenville Health System Cancer Institute
Greenville South Carolina, 29601, United States
SCRI Tennessee Oncology Chattanooga
Chattanooga Tennessee, 37404, United States
SCRI Tennessee Oncology Nashville
Nashville Tennessee, 37211, United States
Texas Oncology (West 38) - USOR
Austin Texas, 78705, United States
Texas Oncology (LOOP) - USOR
Dallas Texas, 75230, United States
Texas Oncology (Walnut) - USOR
Dallas Texas, 75231, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States
Texas Oncology-Fort Worth Cancer Center
Fort Worth Texas, 76104, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock Texas, 79410, United States
Texas Oncology - San Antonio Medical Center - USOR
San Antonio Texas, 78240, United States
Texas Oncology (Tyler) - USOR
Tyler Texas, 75702, United States
Oncology and Hematology Associates of Southwest Virginia, Inc
Roanoke Virginia, 24014, United States
VA Puget Sound Health Care System - NAVREF
Seattle Washington, 98108, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
Medical Oncology Associates
Spokane Washington, 99208, United States
Calvary Mater Newcastle
Newcastle New South Wales, , Australia
Princess Alexandra Hospital
Woolloongabba Queensland, , Australia
Box Hill Hospital
Box Hill Victora, , Australia
St Vincents Hospital Melbourne
Fitzroy Victoria, , Australia
Royal Perth Hospital
Perth Western Australia, 6000, Australia
Monash Health, Monash Medical Centre
Clayton , , Australia
Peninsula Private Hospital
Frankston , 3199, Australia
Ashford Cancer Centre Research
Kurralta Park , 5037, Australia
Icon Cancer Foundation
Milton , 4066, Australia
Border Medical Oncology
Wodonga , , Australia
UZ Brussel
Brussel Brussels, 1090, Belgium
CHU UCL Namur asbl - Site Godinne
Yvoir Namur, , Belgium
GasthuisZusters Antwerpen
Wilrijk , , Belgium
Anhui Province Hospital
Hefei Anhui, 23000, China
Peking university Third Hospital
Beijing Beijing, 10019, China
Peking Union Medical College Hospital
Beijing Beijing, 10073, China
Fujian Medical University Union Hospital
Fuzhou Fujian, 35000, China
Quanzhou First Hospital of Fujian Province
Quanzhou Fujian, 36200, China
Guangdong General Hospital
Guangzhou Guangdong, , China
Nanfang Hospital
Guanzhou Guangdong, 51051, China
Henan Cancer Hospital
Zhengzhou Henan, 45000, China
Wuhan Union Hospital
Wuhan Hubei, 43002, China
Jiangsu Province Hospital
Nanjing Jiangsu, 21002, China
The affiliated Hospital of Xuzhou Medical university
Xuzhou Jiangsu, 22100, China
The First affiliated hospital of Nanchang University
Nanchang Jiangxi, , China
The First Hospital of Jilin University
Changchun Jilin, 13002, China
Shengjing Hospital of China Medical University
Shenyang Liaoning, 11002, China
Tongji Hospital of Tongji University
Shanghai Shanghai, 20009, China
West China Hospital ,Sichuan University
Chengdu Sichuan, 61004, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin Tianjin, 30002, China
The First Hospital of Zhejiang Province
Hangzhou Zhejiang, 31000, China
The first affiliated hospital of Wenzhou Medical University
Wenzhou Zhejiang, 32500, China
Beijing Friendship Hospital-Capital Medical University
Beijing , 10005, China
Zhongshan hospital of Fudan University
Shanghai , 20003, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin , 30006, China
Fakultni nemocnice Brno
Brno Jihomoravský Kraj, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové , , Czechia
Fakultni nemocnice Olomouc
Olomouc , , Czechia
Fakultni nemocnice Ostrava
Ostrava , , Czechia
Hopital Prive Sevigne
Cesson-Sévigné , , France
Centre Hospitalier Departemental de Vendee
La Roche-sur-Yon , , France
Centre Hospitalier Le Mans
Le Mans , , France
Centre Hospitalier Lyon Sud
Pierre Benite , 69495, France
CHRU de Poitiers La Miletrie
Poitiers , , France
CHRU Bretonneau
Tours , , France
Onkologische Schwerpunktpraxis Bielefeld
Bielefeld Nordrhein-Westfalen, 33604, Germany
Evangelisches Krankenhaus Hamm
Hamm Nordrhein-Westfalen, 59063, Germany
Uniklinik Köln
Köln Nordrhein-Westfalen, 50937, Germany
Gemeinschaftspraxis fur Hamatologie und Onkologie
Münster Nordrhein-Westfalen, 48149, Germany
Onkoligische Gemeinschaftspraxis Dres. Dörfel/Göhler
Dresden , 1127, Germany
Fondazione Policlinico Universitario A Gemelli
Roma Lazio, , Italy
Ospedale San Raffaele S.r.l. - PPDS
Milan Milano, , Italy
ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
Milano , , Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino , 10126, Italy
Albert Schweitzer Ziekenhuis
Dordrecht Zuid-Holland, , Netherlands
Gelre Ziekenhuizen
Apeldoorn , , Netherlands
Martini Ziekenhuis
Groningen , , Netherlands
North Shore Hospital
Takapuna Auckland, , New Zealand
Canterbury Health Laboratories
Christchurch South Island, , New Zealand
Middlemore Hospital
Auckland , , New Zealand
Waikato Hospital
Hamilton , , New Zealand
Wellington Hospital
Newtown , 6021, New Zealand
Tauranga Hospital
Tauranga , 3143, New Zealand
Wojewodzki Szpital Specjalistyczny w Legnicy
Legnica Dolnoslaskie, , Poland
Szpital Specjalistyczny w Brzozowie
Brzozów JPodkarpackie, , Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Łódź Lódzkie, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Chorzów Slaskie, , Poland
Interhem Opieka Szpitalna
Białystok , , Poland
Copernicus PL Sp. z o.o. Wojewodzkie Centrum Onkologii
Gdańsk , , Poland
Uniwersyteckie Centrum Kliniczne - PPDS
Gdańsk , , Poland
Pratia MCM Krakow
Kraków , , Poland
Examen sp. z o.o.
Skorzewo , , Poland
Hospital Universitario Central de Asturias
Oviedo Asturias, , Spain
Hospital Universitario Marques de Valdecilla
Santander Cantabria, , Spain
Clinica Universidad Navarra
Pamplona Navarra, , Spain
Hospital Clinic de Barcelona
Barcelona , , Spain
Hospital de La Santa Creu i Sant Pau
Barcelona , , Spain
Hospital del Mar
Barcelona , , Spain
Hospital Universitario Germans Trias i Pujol
Barcelona , , Spain
Hospital Universitario Vall d'Hebrón - PPDS
Barcelona , , Spain
Hospital Universitari de Girona Dr Josep Trueta
Girona , , Spain
Hospital Universitario La Paz
Madrid , , Spain
Hospital Universitario Ramon y Cajal
Madrid , , Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda , , Spain
Hospital Virgen de La Salud
Toledo , , Spain
Skånes Universitetssjukhus i Lund
Lund Skane, , Sweden
Södra Älvsborgs Sjukhus Borås
Borås , 50182, Sweden
Sunderby Sjukhus
Lulea , , Sweden
Karolinska Universitetssjukhuset Solna
Stockholm , 17176, Sweden
Namik Kemal University
Tekirdağ , , Turkey
Aberdeen Royal Infirmary - PPDS
Aberdeen Aberdeen City, , United Kingdom
Norfolk and Norwich University Hospital
Norwich Norfolk, , United Kingdom
Royal Bournemouth Hospital
Sunderland Northumberland, , United Kingdom
Sunderland Royal Hospital
Sunderland Northumberland, , United Kingdom
GenesisCare - Oxford
Oxford Oxfordshire, , United Kingdom
Birmingham Heartlands Hospital
Birmingham , , United Kingdom
Kent and Canterbury Hospital
Canterbury , CT1 3, United Kingdom
St James University Hospital
Leeds , , United Kingdom
Barts Health NHS Trust
London , , United Kingdom
Kings College Hospital
London , , United Kingdom
The Christie NHS Foundation Trust - PPDS
Manchester , , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham , , United Kingdom
Derriford Hospital
Plymouth , , United Kingdom
Southampton General Hospital
Southampton , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

652

Study ID:

NCT03734016

Recruitment Status:

Active, not recruiting

Sponsor:


BeiGene

How clear is this clinincal trial information?

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