Back to resultsA Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma (ROSEWOOD)
Primary Purpose
Relapsed/Refractory Follicular Non-Hodgkin Lymphoma
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Zanubrutinib
Obinutuzumab
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed/Refractory Follicular Non-Hodgkin Lymphoma focused on measuring Relapsed/Refractory Follicular non-Hodgkin Lymphoma
Eligibility Criteria
Key Inclusion Criteria:
- Histologically confirmed diagnosis of B-cell follicular lymphoma
- ≥2 prior systemic treatments for follicular lymphoma.
- Previously received an anti-CD20 antibody and an appropriate alkylator-based combination therapy.
- Disease progression after completion of most recent therapy or refractory disease.
- Presence of measurable disease.
- Availability of archival tissue confirming diagnosis.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
- Adequate renal and hepatic function.
Key Exclusion Criteria:
- Prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor.
- Known central nervous system involvement by leukemia or lymphoma.
- Evidence of transformation from follicular lymphoma to other aggressive histology.
- Allogeneic hematopoietic stem cell transplantation within 12 months of enrollment
- Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix of breast, or localized Gleason score 6 prostate
- Clinically significant cardiovascular disease.
- Major surgery or significant injury ≤ 4 weeks prior to start of study treatment.
- Active fungal, bacterial or viral infection requiring systemic treatment.
- History of severe bleeding disorder.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Emory University
- Northwestern University
- University of Illinois Hospital & Health Sciences System
- Loyola University Medical Center
- Comprehensive Cancer Centers
- Summit Medical Group, PA
- Duke University Medical Center
- Concord Repatriation General Hospital
- Saint Vincent's Hospital Sydney
- Calvary Mater Newcastle Hospital
- Westmead Hospital
- Icon Cancer Care - Wesley
- Icon Cancer Care South Brisbane
- Royal Adelaide Hospital
- Monash Health
- Saint Vincent's Hospital Melbourne
- Peninsula Private Hospital
- Royal Perth Hospital
- The Canberra Hospital
- Gomel Regional Clinical Oncology Dispensary
- Minsk City Clinical Oncological Dispensary
- N.N. Alexandrov National Cancer Centre of Belarus
- Vitebsk Regional Clinical Oncology Dispensary
- University Multiprofile Hospital for Active Treatment Alexandrovska
- University Multiprofile Hospital for Active Treatment Saint Ivan Rilski
- University Multiprofile Hospital for Active Treatment
- Acibadem City Clinic MHAT Tokuda
- The Ottawa Hospital
- Jewish General Hospital
- Peking University People Hospital
- Nanfang Hospital,Southern Medical University
- Tongji Hospital of Tongji Medical College Huazhong University of Science Technology
- Jiangsu Province Hospital
- Fudan University Shanghai Cancer Center
- West China Hospital ,Sichuan University
- Tianjin Medical University Cancer Institute & Hospital
- The First Affiliated Hospital of College of Medicine, Zhejiang University
- Beijing Cancer Hospital
- Peking University Third Hospital
- Second Affiliated Hospital of Army Medical University, PLA (Xinqiao Hospital)
- Guangdong General Hospital
- Harbin Medical University Cancer Hospital
- Henan Cancer Hospital
- Zhejiang Cancer Hospital
- Fakultní Nemocnice Brno
- Všeobecná Fakultní Nemocnice v Praze
- Fakultni Nemocnice Hradec Králové
- Centre de Lutte Contre le Cancer - Institut Bergonie
- Hôpital Haut-Lévêque
- Centre Henri-Becquerel
- Hopital Necker - Enfants Malades
- Clinic Louis Pasteur
- Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois
- Centre Hospitalier de Dunkerque
- Centre Hospitalier Universitaire d'Amiens - Hopital Sud
- Centre Hospitalier Universitaire de Poitier- Hopital de la Miletrie - Hopital Jean Bernard
- Hôpital de la Conception
- Centre Hospitalier Lyon Sud
- Robert-Bosch-Krankenhaus
- Universitätsklinikum Ulm
- Klinikum Augsburg
- Ospedale di Busto Arsizio
- Policlinico di Bari
- Policlinico Sant'Orsola Malpighi
- Istituto Europeo di Oncologia
- Ospedale San Raffaele
- Azienda Unita Sanitaria Locale di Ravenna Ospedale Santa Maria delle Croci
- IRCCS Ospedale di Circolo e Fondazione Macchi
- Kyungpook National University Hospital
- National Cancer Center
- Gachon University Gil Medical Center
- Seoul National University Bundang Hospital
- Inje University Busan Paik Hospital
- Chonnam National University Hwasun Hospital
- Keimyung University Dongsan Medical Center
- Korea University Anam Hospital
- Samsung Medical Center
- Seoul National University Hospital
- Seoul Saint Mary's Hospital
- Severance Hospital, Yonsei University Health System
- Soon Chun Hyang University Hospital Seoul
- Middlemore Hospital
- Auckland City Hospital
- Canterbury Health Labs
- Wojewódzki Szpital Specjalistyczny w Legnicy
- Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
- Centrum Onkologii Ziemi Lubelskiej
- Pratia MCM Kraków
- Szpital Wojewódzki w Opolu
- Uniwersyteckie Centrum Kliniczne
- Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie - Oddział w Gliwicach
- Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev
- N. N. Blokhin Russian Cancer Research Center
- Nizhniy Novgorod Regional Clinical Hospital N.A.
- Rostov State Medical University
- 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
- Central City Hospital # 7
- Institut Català d'Oncologia de l'Hospitalet de Llobregat
- Hospital Universitario Puerta de Hierro - Majadahonda
- Hospital Universitario Quironsalud Madrid
- Hospital Universitario Puerta del Mar
- Hospital Universitario 12 de Octubre
- Hospital Universitario Ramón Y Cajal
- MD Anderson Cancer Center
- Hospital Universitario de Salamanca
- Hospital de Día Quirónsalud Zaragoza
- National Cheng Kung University Hospital
- Changhua Christian Hospital
- Kaohsiung Medical University Hospital
- Taipei Medical University - Shuang Ho Hospital
- E-DA Hospital
- National Taiwan University Hospital
- The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
- Barts Health NHS Trust
- Sarah Cannon Research Institute London
- The Leeds Teaching Hospitals NHS Trust
- Norfolk and Norwich University Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm A
Arm B
Arm Description
Approximately 140 subjects to receive BGB-3111 and obinutuzumab
Approximately 70 subjects to receive obinutuzumab
Outcomes
Primary Outcome Measures
Overall response rate (ORR) as Assessed by Independent Central Review
Secondary Outcome Measures
Overall response rate (ORR) as Assessed by the Investigator
Duration of response (DOR)
Progression free survival (PFS)
Overall Survival (OS)
Complete Response Rate
Complete Metabolic Response Rate
Health-Related Quality of Life (HRQOL) as Assessed by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Health-Related Quality of Life (HRQOL) as Assessed by The 5-level EQ-5D version (EQ-5D-5L)
Time to response (TTR)
Occurrence and severity of treatment-emergent adverse events (TEAEs)
Safety and Tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03332017
Brief Title
A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma
Acronym
ROSEWOOD
Official Title
An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined With Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/ Refractory Follicular Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 15, 2017 (Actual)
Primary Completion Date
June 25, 2022 (Actual)
Study Completion Date
November 2023 (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
The purpose of the study is to evaluate the efficacy, safety and tolerability and of BGB-3111 plus obinutuzumab versus obinutuzumab alone in participants with relapsed/refractory non-Hodgkin follicular lymphoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Follicular Non-Hodgkin Lymphoma
Keywords
Relapsed/Refractory Follicular non-Hodgkin Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
217 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
Approximately 140 subjects to receive BGB-3111 and obinutuzumab
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Approximately 70 subjects to receive obinutuzumab
Intervention Type
Drug
Intervention Name(s)
Zanubrutinib
Other Intervention Name(s)
BGB-3111, Brukinsa
Intervention Description
BGB-3111 will be administered as two 80-mg capsules by mouth twice a day (160 mg twice a day)
Intervention Type
Drug
Intervention Name(s)
Obinutuzumab
Other Intervention Name(s)
Gazyva
Intervention Description
Obinutuzumab will be administered 1,000 mg intravenously on days 1, 8, and 15 of cycle 1, then 1,000 mg on day 1 of cycles 2 to 6, then 1,000 mg every 8 weeks. 1 cycle = 28 days.
Primary Outcome Measure Information:
Title
Overall response rate (ORR) as Assessed by Independent Central Review
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Overall response rate (ORR) as Assessed by the Investigator
Time Frame
up to 3 years
Title
Duration of response (DOR)
Time Frame
up to 3 years
Title
Progression free survival (PFS)
Time Frame
up to 3 years
Title
Overall Survival (OS)
Time Frame
up to 3 years
Title
Complete Response Rate
Time Frame
up to 3 years
Title
Complete Metabolic Response Rate
Time Frame
up to 3 years
Title
Health-Related Quality of Life (HRQOL) as Assessed by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time Frame
up to 3 years
Title
Health-Related Quality of Life (HRQOL) as Assessed by The 5-level EQ-5D version (EQ-5D-5L)
Time Frame
up to 3 years
Title
Time to response (TTR)
Time Frame
up to 3 years
Title
Occurrence and severity of treatment-emergent adverse events (TEAEs)
Description
Safety and Tolerability
Time Frame
up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Histologically confirmed diagnosis of B-cell follicular lymphoma
≥2 prior systemic treatments for follicular lymphoma.
Previously received an anti-CD20 antibody and an appropriate alkylator-based combination therapy.
Disease progression after completion of most recent therapy or refractory disease.
Presence of measurable disease.
Availability of archival tissue confirming diagnosis.
Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
Adequate renal and hepatic function.
Key Exclusion Criteria:
Prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor.
Known central nervous system involvement by leukemia or lymphoma.
Evidence of transformation from follicular lymphoma to other aggressive histology.
Allogeneic hematopoietic stem cell transplantation within 12 months of enrollment
Prior malignancy within the past 2 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix of breast, or localized Gleason score 6 prostate
Clinically significant cardiovascular disease.
Major surgery or significant injury ≤ 4 weeks prior to start of study treatment.
Active fungal, bacterial or viral infection requiring systemic treatment.
History of severe bleeding disorder.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Illinois Hospital & Health Sciences System
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Comprehensive Cancer Centers
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
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
Country
Australia
Facility Name
Saint Vincent's Hospital Sydney
City
Darlinghurst
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
Icon Cancer Care South Brisbane
City
South Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Monash Health
City
Clayton
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
The Canberra Hospital
City
Garran
Country
Australia
Facility Name
Gomel Regional Clinical Oncology Dispensary
City
Gomel
Country
Belarus
Facility Name
Minsk City Clinical Oncological Dispensary
City
Minsk
Country
Belarus
Facility Name
N.N. Alexandrov National Cancer Centre of Belarus
City
Minsk
Country
Belarus
Facility Name
Vitebsk Regional Clinical Oncology Dispensary
City
Vitebsk
Country
Belarus
Facility Name
University Multiprofile Hospital for Active Treatment Alexandrovska
City
Sofia
State/Province
Sofiya-grad
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment Saint Ivan Rilski
City
Sofia
State/Province
Sofiya
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatment
City
Pleven
Country
Bulgaria
Facility Name
Acibadem City Clinic MHAT Tokuda
City
Sofia
Country
Bulgaria
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Jewish General Hospital
City
Montréal
State/Province
Quebec
Country
Canada
Facility Name
Peking University People Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Nanfang Hospital,Southern Medical University
City
Guangzhou
State/Province
Guangzhou
ZIP/Postal Code
510515
Country
China
Facility Name
Tongji Hospital of Tongji Medical College Huazhong University of Science Technology
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
West China Hospital ,Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
The First Affiliated Hospital of College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Facility Name
Second Affiliated Hospital of Army Medical University, PLA (Xinqiao Hospital)
City
Chongqing
Country
China
Facility Name
Guangdong General Hospital
City
Guangzhou
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Heilongjiang
Country
China
Facility Name
Henan Cancer Hospital
City
Henan
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Zhejiang
Country
China
Facility Name
Fakultní Nemocnice Brno
City
Brno
State/Province
Jihormoravsky KRAJ
Country
Czechia
Facility Name
Všeobecná Fakultní Nemocnice v Praze
City
Praha 2
State/Province
Praha
Country
Czechia
Facility Name
Fakultni Nemocnice Hradec Králové
City
Hradec Králové 5
State/Province
Vychodocesky KRAJ
Country
Czechia
Facility Name
Centre de Lutte Contre le Cancer - Institut Bergonie
City
Bordeaux Cedex
State/Province
Aquitaine
Country
France
Facility Name
Hôpital Haut-Lévêque
City
Pessac Cedex
State/Province
Aquitaine
Country
France
Facility Name
Centre Henri-Becquerel
City
Rouen Cedex 1
State/Province
Haute-normandie
Country
France
Facility Name
Hopital Necker - Enfants Malades
City
Paris
State/Province
Ile-de-france
Country
France
Facility Name
Clinic Louis Pasteur
City
Essey-lès-Nancy
State/Province
Limousin, Lorraine
Country
France
Facility Name
Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois
City
Vandœuvre-lès-Nancy
State/Province
Limousin, Lorraine
Country
France
Facility Name
Centre Hospitalier de Dunkerque
City
Dunkerque
State/Province
Nord-pas-de-calais
Country
France
Facility Name
Centre Hospitalier Universitaire d'Amiens - Hopital Sud
City
Amiens Cedex 1
State/Province
Picardie
Country
France
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
Hôpital de la Conception
City
Marseille Cedex 05
State/Province
Provence Alpes COTE D'azur
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Lyon
State/Province
Rhone-alpes
Country
France
Facility Name
Robert-Bosch-Krankenhaus
City
Stuttgart
State/Province
Baden-wuerttemberg
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
State/Province
Baden-wuerttemberg
Country
Germany
Facility Name
Klinikum Augsburg
City
Augsburg
State/Province
Bayern
Country
Germany
Facility Name
Ospedale di Busto Arsizio
City
Busto Arsizio
State/Province
Varese
Country
Italy
Facility Name
Policlinico di Bari
City
Bari
Country
Italy
Facility Name
Policlinico Sant'Orsola Malpighi
City
Bologna
Country
Italy
Facility Name
Istituto Europeo di Oncologia
City
Milano
Country
Italy
Facility Name
Ospedale San Raffaele
City
Milano
Country
Italy
Facility Name
Azienda Unita Sanitaria Locale di Ravenna Ospedale Santa Maria delle Croci
City
Ravenna
Country
Italy
Facility Name
IRCCS Ospedale di Circolo e Fondazione Macchi
City
Varese
Country
Italy
Facility Name
Kyungpook National University Hospital
City
Daegu
State/Province
Chungcheongnam-do
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Inje University Busan Paik Hospital
City
Busan
State/Province
Gyeongsangbuk-do
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
State/Province
Jeollanam-do
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Saint Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
Country
Korea, Republic of
Facility Name
Soon Chun Hyang University Hospital Seoul
City
Seoul
Country
Korea, Republic of
Facility Name
Middlemore Hospital
City
Otahuhu
State/Province
Auckland
Country
New Zealand
Facility Name
Auckland City Hospital
City
Auckland
Country
New Zealand
Facility Name
Canterbury Health Labs
City
Christchurch
Country
New Zealand
Facility Name
Wojewódzki Szpital Specjalistyczny w Legnicy
City
Legnica
State/Province
Dolnoslaskie
Country
Poland
Facility Name
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
City
Łódź
State/Province
Lodzkie
Country
Poland
Facility Name
Centrum Onkologii Ziemi Lubelskiej
City
Lublin
State/Province
Lubelskie
Country
Poland
Facility Name
Pratia MCM Kraków
City
Kraków
State/Province
Malopolskie
Country
Poland
Facility Name
Szpital Wojewódzki w Opolu
City
Opole
State/Province
Opolskie
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdańsk
State/Province
Pomorskie
Country
Poland
Facility Name
Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie - Oddział w Gliwicach
City
Gliwice
State/Province
Slaskie
Country
Poland
Facility Name
Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev
City
Kemerovo
Country
Russian Federation
Facility Name
N. N. Blokhin Russian Cancer Research Center
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Nizhniy Novgorod Regional Clinical Hospital N.A.
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
Rostov State Medical University
City
Rostov
ZIP/Postal Code
344022
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
City
Volgograd
ZIP/Postal Code
400138
Country
Russian Federation
Facility Name
Central City Hospital # 7
City
Yekaterinburg
Country
Russian Federation
Facility Name
Institut Català d'Oncologia de l'Hospitalet de Llobregat
City
L'Hospitalet De Llobregat
State/Province
Barcelona
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro - Majadahonda
City
Majadahonda
State/Province
Madrid
Country
Spain
Facility Name
Hospital Universitario Quironsalud Madrid
City
Pozuelo de Alarcón
State/Province
Madrid
Country
Spain
Facility Name
Hospital Universitario Puerta del Mar
City
Cadiz
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Ramón Y Cajal
City
Madrid
Country
Spain
Facility Name
MD Anderson Cancer Center
City
Madrid
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
Country
Spain
Facility Name
Hospital de Día Quirónsalud Zaragoza
City
Zaragoza
Country
Spain
Facility Name
National Cheng Kung University Hospital
City
Tainan
State/Province
Tainan CITY
Country
Taiwan
Facility Name
Changhua Christian Hospital
City
Changhua
Country
Taiwan
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Taipei Medical University - Shuang Ho Hospital
City
New Taipei City
Country
Taiwan
Facility Name
E-DA Hospital
City
Taipei
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
City
Bournemouth
State/Province
England
Country
United Kingdom
Facility Name
Barts Health NHS Trust
City
London
State/Province
England
Country
United Kingdom
Facility Name
Sarah Cannon Research Institute London
City
London
State/Province
England
Country
United Kingdom
Facility Name
The Leeds Teaching Hospitals NHS Trust
City
Leeds
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospitals NHS Foundation Trust
City
Norwich
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
Citation
Trotman J, Folwer N, Auer R, Flowers C, Reed W, Stern JC, Huang J, Zinzani PL. Phase 2 Obinutuzumab Zanubrutinib (BGB-3111) in Patients with Relapsed/Refractory Follicular Lymphoma (R/R FL). American Society of Clinical Oncology, 2018.
Results Reference
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Citation
Fowler N, Trotman J, Auer R, Flowers C, Reed W, Marimpietri C, Huang J, Zinzani PL.Randomized phase 2 zanubrutinib (BGB-3111) + obinutuzumab (obi) vs obi monotherapy in patients (pts) with relapsed/refractory follicular lymphoma (R/R FL). American Society of Clinical Oncology. 2019
Results Reference
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Citation
Fowler NH, Trotman J, Auer R, Flowers CR, Reed WF, Ivanova E, Huang J, Zinzani PL.Randomized Phase 2 Zanubrutinib (BGB-3111) + Obinutuzumab vs Obinutuzumab Monotherapy in Patients with Relapsed/Refractory Follicular Lymphoma (R/R FL). American Society of Hematology. 2019
Results Reference
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Learn more about this trial
A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma
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