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

Primary Purpose

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Zanubrutinib
Bendamustine
Rituximab
Venetoclax
Sponsored by
BeiGene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring zanubrutinib, BTK inhibitor, bendamustine, rituximab, venetoclax, BGB-3111, Phase 3

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 trial.

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

Sites / Locations

  • Georgetown University Medical Center
  • Emory University
  • Augusta University
  • Northwestern University
  • Montgomery Cancer Center
  • Dana Farber Cancer Institute
  • Research Medical Center - Kansas City
  • Washington University
  • Comprehensive Cancer Centers of Nevada
  • Summit Medical Group, PA
  • Mount Sinai
  • Columbia University Medical Center
  • Memorial Sloan Kettering Cancer Center
  • University of Rochester
  • Duke University Medical Center
  • Oregon Health & Science University
  • Prairie Lakes Healthcare System
  • Tennessee Oncology - Centennial Clinic
  • Joe Arrington Cancer Research and Treatment Center
  • Texas Oncology - Tyler
  • University of Virginia
  • VA Puget Sound Health Care System, Pathology and Laboratory Medicine Services 113
  • Fred Hutchinson Cancer Research Center
  • Concord Hospital
  • The Tweed Hospital
  • Calvary Mater Newcastle Hospital
  • Westmead Hospital
  • Icon Cancer Care - Wesley
  • Royal Brisbane and Women's Hospital
  • Princess Alexandra Hospital
  • Royal Adelaide Hospital
  • The Queen Elizabeth Hospital
  • Royal Hobart Hospital
  • Monash Medical Centre
  • Box Hill Hospital
  • Peter MacCallum Cancer Centre
  • Saint Vincent's Hospital Melbourne
  • Peninsula Private Hospital
  • Royal Perth Hospital
  • Icon Cancer Care - South Brisbane
  • Medizinische Universitätsklinik Innsbruck
  • Allgemeines Krankenhaus der Stadt Linz
  • Krankenhaus der Barmherzigen Schwestern Linz
  • Universitätsklinik für Innere Medizin Salzburg
  • Klinikum Wels-Grieskirchen
  • GasthuisZusters Antwerpen Sint-Augustinus
  • Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne
  • Cliniques du Sud-Luxembourg Site Clinique Saint-Joseph
  • Universitair Ziekenhuis Brussel
  • Universitair Ziekenhuis Gent
  • Centre Hospitalier Universitaire (CHU) de Liège - Site du Sart Tilman
  • Clinique Saint-Pierre
  • Fakultní Nemocnice Brno
  • Fakultní Nemocnice Hradec Králové - Ústav Klinické Imunologie a Alergologie
  • Fakultní Nemocnice Olomouc
  • Fakultní Nemocnice Ostrava
  • Všeobecná Fakultní Nemocnice v Praze
  • Centre Hospitalier Universitaire de Poitier- Hopital de la Miletrie - Hopital Jean Bernard
  • Centre Hospitalier Victor Dupouy d'Argenteuil
  • Institut Bergonié
  • CHU de Caen Côte de Nacre
  • Centre Hospitalier Départemental Vendée
  • Centre Hospitalier Le Mans
  • Centre Hospitalier Universitaire Limoges CHU de Limoges
  • Centre Léon Bérard
  • Institut Paoli Calmettes
  • Centre Hospitalier Universitaire Nantes - Hotel Dieu
  • Groupe Hospitalier Pitie-Salpetriere
  • Groupe Hospitalier du Haut Leveque
  • Centre hospitalier Lyon Sud
  • Hôpital Robert Debré
  • Hôpital Pontchaillou
  • Centre Henri-Becquerel
  • Centre Hospitalier Régional et Universitaire de Tours Hôpital Bretonneau
  • Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois
  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
  • Presidio Ospedale di Montichiari
  • Presidio Ospedaliero di Gardone Val Trompia
  • Azienda Ospedaliera Universitaria San Martino
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Ospedale San Raffaele
  • Universita Degli Studi di Modena-Azienda Ospedaliere Policlinco
  • Azienda Unita Sanitaria Locale di Ravenna
  • Fondazione Policlinico Universitario Agostino Gemelli
  • Universita degli Studi di Roma "La Sapienza" - Umberto I Policlinico di Roma
  • Ospedale Casa Sollievo della Sofferenza
  • Azienda Ospedaliera Santa Maria di Terni
  • Azienda Ospedaliera Città della Salute e della Scienza di Torino
  • North Shore Hospital
  • Auckland City Hospital
  • Palmerston North Hospital
  • Christchurch Hospital
  • Tauranga Hospital
  • Wojewódzki Szpital Specjalistyczny w Legnicy
  • Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny im. Ks. B. Markiewicza
  • Samodzielny Publiczny Zakład Opieki Zdrowotnej Zespół Szpitali Miejskich
  • Copernicus Podmiot Leczniczy Wojewódzkiego Centrum Onkologii
  • Szpitale Pomorskie Spółka z ograniczoną odpowiedzialnością
  • Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie, Oddział w Gliwicach
  • Malopolskie Centrum Medyczne
  • Centrum Onkologii Ziemi Lubelskiej
  • Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
  • Sverdlovsk Regional Clinical Hospital #1
  • Kaluga Regional Hospital
  • Clinical Oncology Dispensary, Kazan
  • Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev
  • City Clinical Hospital No. 52 of the Moscow Healthcare Department
  • N. N. Blokhin Russian Cancer Research Center
  • Nizhniy Novgorod Regional Clinical Hospital N.A.
  • Penza Regional Oncology Dispensary
  • Municipal Healthcare Institution "Clinical Medical Sanitary Establishment #1"
  • Ryazan Regional Clinical Hospital
  • FGU Russian Scientific Research Institute of Hematology and Transfusiology
  • State Healthcare Institution Oncologic Dispensary No. 2 - Health Department of Krasnodar Region
  • Tula Area Clinical Hospital
  • State Budgetary Healthcare Institution "Volgograd Regional Clinical Oncology Dispensary #1"
  • Central City Hospital # 7
  • Institut Català d'Oncologia
  • Hospital Universitari Parc Taulí
  • Hospital del Mar
  • Hospital Universitario Vall d'Hebron
  • Institut Català d'Oncologia - L'Hospitalet de Llobregat
  • Clinica Universidad de Navarra Madrid
  • Hospital Universitario de La Princesa
  • Hospital Universitario Ramón Y Cajal
  • MD Anderson Cancer Center - Madrid
  • Hospital Universitario Puerta de Hierro - Majadahonda
  • Clínica Universidad de Navarra Pamplona
  • Hospital Universitario La Fe
  • Hospital de Día Quirónsalud Zaragoza
  • Skånes Universitetssjukhus i Lund
  • Södra Älvsborgs Sjukhus - Borås
  • Sahlgrenska Universitetssjukhuset, Östra sjukhuset
  • Sunderby Sjukhus
  • Universitetssjukhuset Örebro
  • Karolinska Universitetssjukhuset - Solna
  • Uppsala Akademiska Sjukhus
  • Hualien Tzu Chi Hospital
  • Taipei Medical University - Shuang Ho Hospital
  • Chi Mei Hospital Liouying
  • National Taiwan University Hospital
  • Heart of England NHS Foundation Trust
  • Cambridge University Hospitals NHS Foundation Trust
  • East Kent Hospitals University NHS Foundation Trust
  • Sarah Cannon Research Institute London
  • Maidstone and Tunbridge Wells NHS Trust
  • The Christie NHS Foundation Trust
  • The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
  • The Leeds Teaching Hospitals NHS Trust
  • Barts and The London NHS Trust
  • The Royal Marsden NHS Foundation Trust
  • Norfolk and Norwich University Hospital
  • Nottingham University Hospitals NHS Trust
  • Derriford Hospital
  • Southampton General Hospital
  • City Hospitals Sunderland NHS Foundation Trust
  • The Royal Marsden NHS Foundation Trust
  • The Royal Wolverhampton NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1, Arm A: Zanubrutinib

Cohort 1, Arm B: B+R

Cohort 1a, Arm A (China only): Zanubrutinib

Cohort 1a, Arm B (China only): B + R

Cohort 2, Arm C: Zanubrutinib

Cohort 3, Arm D: Venetoclax + zanubrutinib

Arm Description

Participants will receive zanubrutinib until unacceptable toxicity or disease progression

Participants will receive bendamustine plus rituximab for up to six 28-day cycles

Participants will receive zanubrutinib until unacceptable toxicity or disease progression

Participants will receive bendamustine plus rituximab for up to six 28-day cycles

Participants will receive zanubrutinib until unacceptable toxicity or disease progression

Approximately 110 participants, 50 without del17p and 60 with del[17p] or TP53 mutation will receive venetoclax until unacceptable toxicity, disease progression, or for maximum of 24 cycles; Participants will also receive zanubrutinib for a minimum of 27 cycles, or until unacceptable toxicity or disease progression, whichever occurs first. Each cycle is 28 days.

Outcomes

Primary Outcome Measures

Cohort 1: Progression-free survival (PFS) between treatment groups (Zanubrutinib vs. B+R) as determined by independent central review (ICR).

Secondary Outcome Measures

Cohort 1: Overall response rate (ORR) between treatment groups
Pooled Cohort 1/1a: Overall response rate (ORR) between treatment groups
Cohort 1: Overall survival (OS) between treatment groups
Cohort 1: Duration of response (DOR) between treatment groups
Pooled Cohort 1/1a: Duration of response (DOR) between treatment groups
Cohort 1: Progression-free survival (PFS) between treatment groups determined by investigator assessment (IA).
Pooled Cohort 1/1a: Progression-free survival (PFS) between treatment groups determined by investigator assessment (IA).
Cohort 1: Patient-reported outcomes as assessed by the (European Quality Of Life 5D 5L) EQ-5D-5L questionnaire
Cohort 1: Patient-reported outcomes as assessed by the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) questionnaire.
Cohort 2: Overall response rate (ORR)
Cohort 2: Progression-free survival (PFS)
Cohort 2: Duration of response (DOR)
Cohort 3: Overall response rate (ORR)
Cohort 3: Progression-free survival (PFS)
Cohort 3: Duration of response (DOR)
Cohort 3: Rate of undetectable minimal residual disease (MRD4)
Number of participants experiencing Adverse Events (AEs)
Number of participants experiencing Serious Adverse Events (SAEs)
Apparent rate of clearance of zanubrutinib from plasma (CL/F)CL/F
Cohort 1 Zanubrutinib only arms: Area-Under-Curve from time 0 to 12 hours postdose (AUC0-12)
Cohort 3: Area-Under-Curve from time 0 to 12 hours postdose (AUC0-12) of zanubrutinib

Full Information

First Posted
November 1, 2017
Last Updated
March 6, 2023
Sponsor
BeiGene
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1. Study Identification

Unique Protocol Identification Number
NCT03336333
Brief Title
A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL
Acronym
SEQUOIA
Official Title
An International, Phase 3, Open-Label, Randomized Study of BGB-3111 Compared With Bendamustine Plus Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2, 2017 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To compare efficacy between zanubrutinib versus bendamustine and rituximab in patients with previously untreated CLL/SLL, as measured by progression free survival.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Keywords
zanubrutinib, BTK inhibitor, bendamustine, rituximab, venetoclax, BGB-3111, Phase 3

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
740 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1, Arm A: Zanubrutinib
Arm Type
Experimental
Arm Description
Participants will receive zanubrutinib until unacceptable toxicity or disease progression
Arm Title
Cohort 1, Arm B: B+R
Arm Type
Experimental
Arm Description
Participants will receive bendamustine plus rituximab for up to six 28-day cycles
Arm Title
Cohort 1a, Arm A (China only): Zanubrutinib
Arm Type
Experimental
Arm Description
Participants will receive zanubrutinib until unacceptable toxicity or disease progression
Arm Title
Cohort 1a, Arm B (China only): B + R
Arm Type
Experimental
Arm Description
Participants will receive bendamustine plus rituximab for up to six 28-day cycles
Arm Title
Cohort 2, Arm C: Zanubrutinib
Arm Type
Experimental
Arm Description
Participants will receive zanubrutinib until unacceptable toxicity or disease progression
Arm Title
Cohort 3, Arm D: Venetoclax + zanubrutinib
Arm Type
Experimental
Arm Description
Approximately 110 participants, 50 without del17p and 60 with del[17p] or TP53 mutation will receive venetoclax until unacceptable toxicity, disease progression, or for maximum of 24 cycles; Participants will also receive zanubrutinib for a minimum of 27 cycles, or until unacceptable toxicity or disease progression, whichever occurs first. Each cycle is 28 days.
Intervention Type
Drug
Intervention Name(s)
Zanubrutinib
Other Intervention Name(s)
BGB-3111, BRUKINSA
Intervention Description
Administered as two 80-mg capsules by mouth twice a day (160 mg twice a day)
Intervention Type
Drug
Intervention Name(s)
Bendamustine
Other Intervention Name(s)
Treanda, Ribomustin, and Levact
Intervention Description
Administered intravenously (IV) at a dose of 90 mg/m2/day on the first 2 days of each cycle for 6 cycles.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan, MabThera
Intervention Description
Administered intravenously (IV) at a dose of 375 mg/m2 on day 0 of cycle 1, and at a dose of 500 mg/m2 on day 1 of cycles 2 to 6.
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Other Intervention Name(s)
Venclexta, Venclyxto
Intervention Description
400mg tablets administered orally once daily.
Primary Outcome Measure Information:
Title
Cohort 1: Progression-free survival (PFS) between treatment groups (Zanubrutinib vs. B+R) as determined by independent central review (ICR).
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Cohort 1: Overall response rate (ORR) between treatment groups
Time Frame
Up to 5 years
Title
Pooled Cohort 1/1a: Overall response rate (ORR) between treatment groups
Time Frame
Up to 5 yearsl
Title
Cohort 1: Overall survival (OS) between treatment groups
Time Frame
Up to 5 years.
Title
Cohort 1: Duration of response (DOR) between treatment groups
Time Frame
Up to 5 years
Title
Pooled Cohort 1/1a: Duration of response (DOR) between treatment groups
Time Frame
Up to 5 years
Title
Cohort 1: Progression-free survival (PFS) between treatment groups determined by investigator assessment (IA).
Time Frame
Up to 5 years
Title
Pooled Cohort 1/1a: Progression-free survival (PFS) between treatment groups determined by investigator assessment (IA).
Time Frame
Up to 5 years
Title
Cohort 1: Patient-reported outcomes as assessed by the (European Quality Of Life 5D 5L) EQ-5D-5L questionnaire
Time Frame
Up to 5 years
Title
Cohort 1: Patient-reported outcomes as assessed by the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30) questionnaire.
Time Frame
Up to 5 years
Title
Cohort 2: Overall response rate (ORR)
Time Frame
Up to 5 years
Title
Cohort 2: Progression-free survival (PFS)
Time Frame
Up to 5 years
Title
Cohort 2: Duration of response (DOR)
Time Frame
Up to 5 years
Title
Cohort 3: Overall response rate (ORR)
Time Frame
Up to 5 years.
Title
Cohort 3: Progression-free survival (PFS)
Time Frame
Up to 5 years.
Title
Cohort 3: Duration of response (DOR)
Time Frame
Up to 5 years.
Title
Cohort 3: Rate of undetectable minimal residual disease (MRD4)
Time Frame
Up to 5 years.
Title
Number of participants experiencing Adverse Events (AEs)
Time Frame
Up to 5 years.
Title
Number of participants experiencing Serious Adverse Events (SAEs)
Time Frame
Up to 5 years.
Title
Apparent rate of clearance of zanubrutinib from plasma (CL/F)CL/F
Time Frame
Predose up to 12 hours postdose
Title
Cohort 1 Zanubrutinib only arms: Area-Under-Curve from time 0 to 12 hours postdose (AUC0-12)
Time Frame
Predose up to 12 hours postdose
Title
Cohort 3: Area-Under-Curve from time 0 to 12 hours postdose (AUC0-12) of zanubrutinib
Time Frame
Predose up to 12 hours postdose

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
31875923
Citation
Mu S, Tang Z, Novotny W, Tawashi M, Li TK, Ou Y, Sahasranaman S. Effect of rifampin and itraconazole on the pharmacokinetics of zanubrutinib (a Bruton's tyrosine kinase inhibitor) in Asian and non-Asian healthy subjects. Cancer Chemother Pharmacol. 2020 Feb;85(2):391-399. doi: 10.1007/s00280-019-04015-w. Epub 2019 Dec 26.
Results Reference
result
PubMed Identifier
33054121
Citation
Tam CS, Robak T, Ghia P, Kahl BS, Walker P, Janowski W, Simpson D, Shadman M, Ganly PS, Laurenti L, Opat S, Tani M, Ciepluch H, Verner E, Simkovic M, Osterborg A, Trneny M, Tedeschi A, Paik JC, Kuwahara SB, Feng S, Ramakrishnan V, Cohen A, Huang J, Hillmen P, Brown JR. Zanubrutinib monotherapy for patients with treatment naive chronic lymphocytic leukemia and 17p deletion. Haematologica. 2020 Oct 13;106(9):2354-2363. doi: 10.3324/haematol.2020.259432.
Results Reference
result
PubMed Identifier
35810754
Citation
Tam CS, Brown JR, Kahl BS, Ghia P, Giannopoulos K, Jurczak W, Simkovic M, Shadman M, Osterborg A, Laurenti L, Walker P, Opat S, Chan H, Ciepluch H, Greil R, Tani M, Trneny M, Brander DM, Flinn IW, Grosicki S, Verner E, Tedeschi A, Li J, Tian T, Zhou L, Marimpietri C, Paik JC, Cohen A, Huang J, Robak T, Hillmen P. Zanubrutinib versus bendamustine and rituximab in untreated chronic lymphocytic leukaemia and small lymphocytic lymphoma (SEQUOIA): a randomised, controlled, phase 3 trial. Lancet Oncol. 2022 Aug;23(8):1031-1043. doi: 10.1016/S1470-2045(22)00293-5. Epub 2022 Jul 7. Erratum In: Lancet Oncol. 2023 Mar;24(3):e106.
Results Reference
derived

Learn more about this trial

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

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