Chronic Lymphocytic Leukemia Clinical Trial

A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL

Summary

To compare efficacy between zanubrutinib versus bendamustine and rituximab in patients with previously untreated leukemia-cll/" >CLL/SLL, as measured by progression free survival.

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Full Description

This is a global phase 3, open label, randomized study of zanubrutinib versus bendamustine plus rituximab (B+R) in participants with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), including participants without del(17p) [Cohort 1] and participants with del(17p) [Cohort 2 and Cohort 3]. Participants in Cohort 1 are randomized 1:1 to zanubrutinib (Arm A) or bendamustine plus rituximab (Arm B). Randomization will be stratified by age, Binet stage, immunoglobulin variable region heavy chain (IGHV) mutational status, and geographic region. Participants in Cohort 2 will receive treatment with zanubrutinib. Participants in Cohort 3 will receive treatment with zanubrutinib and venetoclax.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Unsuitable for chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab (FCR)
Confirmed diagnosis of CD20-positive CLL or SLL, requiring treatment
Measurable disease by imaging
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Life expectancy ≥ 6 months
Adequate bone marrow function
Adequate renal and hepatic function

Key Exclusion Criteria:

Previous systemic treatment for CLL/SLL
Requires ongoing need for corticosteroid treatment
Known prolymphocytic leukemia or history of or 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 of breast, or localized Gleason score 6 prostate cancer
History of severe bleeding disorder
History of stroke or intracranial hemorrhage within 6 months before the first dose of study drug
Severe or debilitating pulmonary disease
Inability to swallow capsules or disease affecting gastrointestinal function
Active infection requiring systemic treatment
Known central nervous system involvement by leukemia or lymphoma
Underlying medical condition that will render the administration of study drug hazardous or obscure interpretation of toxicity or AEs
Known infection with human immunodeficiency virus (HIV) or active hepatitis B or C infection
Major surgery ≤ 4 weeks prior to start of study treatment
Pregnant or nursing females
Vaccination with live vaccine within 35 days prior to the first dose of study drug.
Ongoing alcohol or drug addiction
Known hypersensitivity to zanubrutinib, bendamustine, rituximab, or venetoclax (as applicable) or any other ingredients of the study drugs
Requires ongoing treatment with strong cytochrome P450 (CYP3A) inhibitor or inducer
Concurrent participation in another therapeutic clinical study

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

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

590

Study ID:

NCT03336333

Recruitment Status:

Active, not recruiting

Sponsor:

BeiGene

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There are 43 Locations for this study

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Georgetown University Medical Center
Washington District of Columbia, 20007, United States
Emory University
Atlanta Georgia, 30322, United States
Augusta University
Augusta Georgia, 30912, United States
Northwestern University
Chicago Illinois, 60208, United States
Montgomery Cancer Center
Mount Sterling Kentucky, 40353, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Research Medical Center - Kansas City
Kansas City Missouri, 64132, United States
Washington University
Saint Louis Missouri, 63110, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89014, United States
Summit Medical Group, PA
Florham Park New Jersey, 07932, United States
Mount Sinai
New York New York, 10029, United States
Columbia University Medical Center
New York New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
University of Rochester
Rochester New York, 14642, United States
Duke University Medical Center
Durham North Carolina, 27705, United States
Oregon Health & Science University
Portland Oregon, 97239, United States
Prairie Lakes Healthcare System
Watertown South Dakota, 57201, United States
Tennessee Oncology - Centennial Clinic
Nashville Tennessee, 37203, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock Texas, 79410, United States
Texas Oncology - Tyler
Tyler Texas, 75702, United States
University of Virginia
Charlottesville Virginia, 22908, United States
VA Puget Sound Health Care System, Pathology and Laboratory Medicine Services 113
Seattle Washington, 98108, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
Concord Hospital
Concord New South Wales, 2139, Australia
The Tweed Hospital
Tweed Heads New South Wales, , Australia
Calvary Mater Newcastle Hospital
Waratah New South Wales, , Australia
Westmead Hospital
Westmead New South Wales, , Australia
Icon Cancer Care - Wesley
Auchenflower Queensland, , Australia
Royal Brisbane and Women's Hospital
Herston Queensland, , Australia
Princess Alexandra Hospital
Woolloongabba Queensland, , Australia
Royal Adelaide Hospital
Adelaide South Australia, , Australia
The Queen Elizabeth Hospital
Woodville South South Australia, , Australia
Royal Hobart Hospital
Hobart Tasmania, , Australia
Monash Medical Centre
Bentleigh East Victoria, , Australia
Box Hill Hospital
Box Hill Victoria, , Australia
Peter MacCallum Cancer Centre
East Melbourne Victoria, , Australia
Saint Vincent's Hospital Melbourne
Fitzroy Victoria, , Australia
Peninsula Private Hospital
Frankston Victoria, , Australia
Royal Perth Hospital
Perth Western Australia, , Australia
Icon Cancer Care - South Brisbane
South Brisbane , , Australia
Medizinische Universitätsklinik Innsbruck
Innsbruck , , Austria
Allgemeines Krankenhaus der Stadt Linz
Linz , , Austria
Krankenhaus der Barmherzigen Schwestern Linz
Linz , , Austria
Universitätsklinik für Innere Medizin Salzburg
Salzburg , , Austria
Klinikum Wels-Grieskirchen
Wels , , Austria
GasthuisZusters Antwerpen Sint-Augustinus
Wilrijk Antwerpen, , Belgium
Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne
Yvoir Namur, , Belgium
Cliniques du Sud-Luxembourg Site Clinique Saint-Joseph
Arlon , , Belgium
Universitair Ziekenhuis Brussel
Brussels , , Belgium
Universitair Ziekenhuis Gent
Gent , , Belgium
Centre Hospitalier Universitaire (CHU) de Liège - Site du Sart Tilman
Liège , , Belgium
Clinique Saint-Pierre
Ottignies , , Belgium
Anhui Provincial Hospital
Hefei Anhui, 23000, China
Peking University Third Hospital
Beijing Beijing, 10000, China
Beijing Friendship Hospital, Capital Medical University
Beijing Beijing, 10005, China
Peking Union Medical College Hospital
Beijing Beijing, 10073, China
Xinqiao Hospital
Chongqing Chongqing, 40003, China
Fujian Medical University Union Hospital
Fuzhou Fujian, 35000, China
Quanzhou First Affiliated Hospital of Fujian Medical University
Quanzhou Fujian, 36200, China
Guangdong Provincial People's Hospital
Guangzhou Guangdong, 51008, China
Henan Cancer Hospital
Zhengzhou Henan, 45000, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan Hubei, 43002, China
Jiangsu Province Hospital
Nanjing Jiangsu, 29002, China
The First Affiliated Hospital of Soochow University Branch Shizi
Suzhou Jiangsu, 21500, China
Wuxi People's Hospital
Wuxi Jiangsu, 21402, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang Jiangxi, 33000, China
The First Hospital of Jilin University
Changchun Jilin, 13002, China
West China Hospital, Sichuan University
Chengdu Sichuan, 61004, China
Institute of Hematology and Hospital of Blood Disease
Tianjin Tianjin, 30002, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin Tianjin, 30006, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou Zhejiang, 31000, China
Fakultní Nemocnice Brno
Brno , , Czechia
Fakultní Nemocnice Hradec Králové - Ústav Klinické Imunologie a Alergologie
Hradec Králové , , Czechia
Fakultní Nemocnice Olomouc
Olomouc , , Czechia
Fakultní Nemocnice Ostrava
Ostrava-Poruba , , Czechia
Všeobecná Fakultní Nemocnice v Praze
Praha , , Czechia
Centre Hospitalier Universitaire de Poitier- Hopital de la Miletrie - Hopital Jean Bernard
Poitiers Cedex Poitou-charentes, , France
Centre Hospitalier Victor Dupouy d'Argenteuil
Argenteuil , , France
Institut Bergonié
Bordeaux , , France
CHU de Caen Côte de Nacre
Caen , , France
Centre Hospitalier Départemental Vendée
La Roche sur Yon , , France
Centre Hospitalier Le Mans
Le Mans , , France
Centre Hospitalier Universitaire Limoges CHU de Limoges
Limoges , , France
Centre Léon Bérard
Lyon , , France
Institut Paoli Calmettes
Marseille , , France
Centre Hospitalier Universitaire Nantes - Hotel Dieu
Nantes , , France
Groupe Hospitalier Pitie-Salpetriere
Paris , , France
Groupe Hospitalier du Haut Leveque
Pessac , , France
Centre hospitalier Lyon Sud
Pierre-Bénite , , France
Hôpital Robert Debré
Reims , , France
Hôpital Pontchaillou
Rennes , , France
Centre Henri-Becquerel
Rouen , , France
Centre Hospitalier Régional et Universitaire de Tours Hôpital Bretonneau
Tours , , France
Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois
Vandoeuvre-lès-Nancy , , France
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia , , Italy
Presidio Ospedale di Montichiari
Brescia , , Italy
Presidio Ospedaliero di Gardone Val Trompia
Brescia , , Italy
Azienda Ospedaliera Universitaria San Martino
Genova , , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola , , Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milano , , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milano , , Italy
Ospedale San Raffaele
Milano , , Italy
Universita Degli Studi di Modena-Azienda Ospedaliere Policlinco
Modena , , Italy
Azienda Unita Sanitaria Locale di Ravenna
Ravenna , , Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma , , Italy
Universita degli Studi di Roma "La Sapienza" - Umberto I Policlinico di Roma
Roma , , Italy
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo , , Italy
Azienda Ospedaliera Santa Maria di Terni
Terni , , Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino , , Italy
North Shore Hospital
North Shore Auckland, , New Zealand
Auckland City Hospital
Grafton Aukland, , New Zealand
Palmerston North Hospital
Palmerston North Manawatu-wanganui, , New Zealand
Christchurch Hospital
Christchurch , , New Zealand
Tauranga Hospital
Tauranga , , New Zealand
Wojewódzki Szpital Specjalistyczny w Legnicy
Legnica Dolnoslaskie, , Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im. Ks. B. Markiewicza
Brzozów , , Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej Zespół Szpitali Miejskich
Chorzów , , Poland
Copernicus Podmiot Leczniczy Wojewódzkiego Centrum Onkologii
Gdańsk , , Poland
Szpitale Pomorskie Spółka z ograniczoną odpowiedzialnością
Gdynia , , Poland
Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie, Oddział w Gliwicach
Gliwice , , Poland
Malopolskie Centrum Medyczne
Kraków , , Poland
Centrum Onkologii Ziemi Lubelskiej
Lublin , , Poland
Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
Łódź , , Poland
Sverdlovsk Regional Clinical Hospital #1
Ekaterinburg , , Russian Federation
Kaluga Regional Hospital
Kaluga , , Russian Federation
Clinical Oncology Dispensary, Kazan
Kazan , , Russian Federation
Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev
Kemerovo , , Russian Federation
City Clinical Hospital No. 52 of the Moscow Healthcare Department
Moscow , , Russian Federation
N. N. Blokhin Russian Cancer Research Center
Moscow , , Russian Federation
Nizhniy Novgorod Regional Clinical Hospital N.A.
Nizhny Novgorod , , Russian Federation
Penza Regional Oncology Dispensary
Penza , , Russian Federation
Municipal Healthcare Institution "Clinical Medical Sanitary Establishment #1"
Perm , , Russian Federation
Ryazan Regional Clinical Hospital
Ryazan , , Russian Federation
FGU Russian Scientific Research Institute of Hematology and Transfusiology
Saint Petersburg , , Russian Federation
State Healthcare Institution Oncologic Dispensary No. 2 - Health Department of Krasnodar Region
Sochi , , Russian Federation
Tula Area Clinical Hospital
Tula , , Russian Federation
State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Dispensary #1"
Volgograd , , Russian Federation
Central City Hospital # 7
Yekaterinburg , , Russian Federation
Institut Català d'Oncologia
Badalona Barcelona, , Spain
Hospital Universitari Parc Taulí
Sabadell Barcelona, , Spain
Hospital del Mar
Barcelona , , Spain
Hospital Universitario Vall d'Hebron
Barcelona , , Spain
Institut Català d'Oncologia - L'Hospitalet de Llobregat
Barcelona , , Spain
Clinica Universidad de Navarra Madrid
Madrid , , Spain
Hospital Universitario de La Princesa
Madrid , , Spain
Hospital Universitario Ramón Y Cajal
Madrid , , Spain
MD Anderson Cancer Center - Madrid
Madrid , , Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda , , Spain
Clínica Universidad de Navarra Pamplona
Pamplona , , Spain
Hospital Universitario La Fe
Valencia , , Spain
Hospital de Día Quirónsalud Zaragoza
Zaragoza , , Spain
Skånes Universitetssjukhus i Lund
Lund Skane, , Sweden
Södra Älvsborgs Sjukhus - Borås
Borås Vastra Gotaland, , Sweden
Sahlgrenska Universitetssjukhuset, Östra sjukhuset
Göteborg Vastra Gotaland, , Sweden
Sunderby Sjukhus
Lulea , , Sweden
Universitetssjukhuset Örebro
Orebro , , Sweden
Karolinska Universitetssjukhuset - Solna
Stockholm , , Sweden
Uppsala Akademiska Sjukhus
Uppsala , , Sweden
Hualien Tzu Chi Hospital
Hualien City , , Taiwan
Taipei Medical University - Shuang Ho Hospital
New Taipei City , , Taiwan
Chi Mei Hospital Liouying
Tainan City , , Taiwan
National Taiwan University Hospital
Taipei , , Taiwan
Heart of England NHS Foundation Trust
Birmingham England, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge England, , United Kingdom
East Kent Hospitals University NHS Foundation Trust
Canterbury England, , United Kingdom
Sarah Cannon Research Institute London
London England, , United Kingdom
Maidstone and Tunbridge Wells NHS Trust
Maidstone England, , United Kingdom
The Christie NHS Foundation Trust
Manchester England, , United Kingdom
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Bournemouth , , United Kingdom
The Leeds Teaching Hospitals NHS Trust
Leeds , , United Kingdom
Barts and The London NHS Trust
London , , United Kingdom
The Royal Marsden NHS Foundation Trust
London , , United Kingdom
Norfolk and Norwich University Hospital
Norwich , , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham , , United Kingdom
Derriford Hospital
Plymouth , , United Kingdom
Southampton General Hospital
Southampton , , United Kingdom
City Hospitals Sunderland NHS Foundation Trust
Sunderland , , United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton , , United Kingdom
The Royal Wolverhampton NHS Trust
Wolverhampton , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

590

Study ID:

NCT03336333

Recruitment Status:

Active, not recruiting

Sponsor:


BeiGene

How clear is this clinincal trial information?

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