A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma (ROSEWOOD)

October 25, 2023 updated by: BeiGene

An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined With Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/ Refractory Follicular Lymphoma

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

217

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Garran, Australia
        • The Canberra Hospital
    • New South Wales
      • Concord, New South Wales, Australia
        • Concord Repatriation General Hospital
      • Darlinghurst, New South Wales, Australia
        • Saint Vincent's Hospital Sydney
      • Waratah, New South Wales, Australia
        • Calvary Mater Newcastle Hospital
      • Westmead, New South Wales, Australia
        • Westmead Hospital
    • Queensland
      • Auchenflower, Queensland, Australia
        • Icon Cancer Care - Wesley
      • South Brisbane, Queensland, Australia
        • Icon Cancer Care South Brisbane
    • South Australia
      • Adelaide, South Australia, Australia
        • Royal Adelaide Hospital
    • Victoria
      • Clayton, Victoria, Australia
        • Monash Health
      • Fitzroy, Victoria, Australia
        • Saint Vincent's Hospital Melbourne
      • Frankston, Victoria, Australia
        • Peninsula Private Hospital
    • Western Australia
      • Perth, Western Australia, Australia
        • Royal Perth Hospital
  • Belarus
      • Gomel, Belarus
        • Gomel Regional Clinical Oncology Dispensary
      • Minsk, Belarus
        • Minsk city Clinical Oncological Dispensary
      • Minsk, Belarus
        • N.N. Alexandrov National Cancer Centre of Belarus
      • Vitebsk, Belarus
        • Vitebsk Regional Clinical Oncology Dispensary
  • Bulgaria
      • Pleven, Bulgaria
        • University Multiprofile Hospital for Active Treatment
      • Sofia, Bulgaria
        • Acibadem City Clinic MHAT Tokuda
    • Sofiya
      • Sofia, Sofiya, Bulgaria
        • University Multiprofile Hospital for Active Treatment Saint Ivan Rilski
    • Sofiya-grad
      • Sofia, Sofiya-grad, Bulgaria
        • University Multiprofile Hospital for Active Treatment Alexandrovska
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada
        • The Ottawa Hospital
    • Quebec
      • Montréal, Quebec, Canada
        • Jewish General Hospital
  • China
      • Beijing, China
        • Peking University Third Hospital
      • Beijing, China
        • Beijing Cancer Hospital
      • Chongqing, China
        • Second Affiliated Hospital of Army Medical University, PLA (Xinqiao Hospital)
      • Guangzhou, China
        • Guangdong General Hospital
      • Heilongjiang, China
        • Harbin Medical University Cancer Hospital
      • Henan, China
        • Henan Cancer Hospital
      • Zhejiang, China
        • Zhejiang Cancer Hospital
    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University People Hospital
    • Guangzhou
      • Guangzhou, Guangzhou, China, 510515
        • Nanfang Hospital，Southern Medical University
    • Hubei
      • Wuhan, Hubei, China
        • Tongji Hospital of Tongji Medical College Huazhong University of Science Technology
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Jiangsu Province Hospital
    • Shanghai
      • Shanghai, Shanghai, China
        • Fudan University Shanghai Cancer Center
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital ,Sichuan University
    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin Medical University Cancer Institute & Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The First Affiliated Hospital of College of Medicine, Zhejiang University
  • Czechia
    • Jihormoravsky KRAJ
      • Brno, Jihormoravsky KRAJ, Czechia
        • Fakultni nemocnice Brno
    • Praha
      • Praha 2, Praha, Czechia
        • Vseobecna fakultni nemocnice v Praze
    • Vychodocesky KRAJ
      • Hradec Králové 5, Vychodocesky KRAJ, Czechia
        • Fakultni nemocnice Hradec Kralove
  • France
    • Aquitaine
      • Bordeaux Cedex, Aquitaine, France
        • Centre de Lutte Contre le Cancer - Institut Bergonie
      • Pessac Cedex, Aquitaine, France
        • Hôpital Haut-Lévêque
    • Haute-normandie
      • Rouen Cedex 1, Haute-normandie, France
        • Centre Henri-Becquerel
    • Ile-de-france
      • Paris, Ile-de-france, France
        • Hôpital Necker - Enfants Malades
    • Limousin, Lorraine
      • Essey-lès-Nancy, Limousin, Lorraine, France
        • Clinic Louis Pasteur
      • Vandœuvre-lès-Nancy, Limousin, Lorraine, France
        • Centre Hospitalier Universitaire de Nancy - Hopital de Brabois
    • Nord-pas-de-calais
      • Dunkerque, Nord-pas-de-calais, France
        • Centre Hospitalier de Dunkerque
    • Picardie
      • Amiens Cedex 1, Picardie, France
        • Centre Hospitalier Universitaire d'Amiens - Hopital Sud
    • Poitou-charentes
      • Poitiers Cedex, Poitou-charentes, France
        • Centre Hospitalier Universitaire de Poitier- Hopital de la Miletrie - Hopital Jean Bernard
    • Provence Alpes COTE D'azur
      • Marseille Cedex 05, Provence Alpes COTE D'azur, France
        • Hôpital de la Conception
    • Rhone-alpes
      • Lyon, Rhone-alpes, France
        • Centre Hospitalier Lyon Sud
  • Germany
    • Baden-wuerttemberg
      • Stuttgart, Baden-wuerttemberg, Germany
        • Robert-Bosch-Krankenhaus
      • Ulm, Baden-wuerttemberg, Germany
        • Universitatsklinikum Ulm
    • Bayern
      • Augsburg, Bayern, Germany
        • Klinikum Augsburg
  • Italy
      • Bari, Italy
        • Policlinico di Bari
      • Bologna, Italy
        • Policlinico Sant'Orsola Malpighi
      • Milano, Italy
        • Istituto Europeo di Oncologia
      • Milano, Italy
        • Ospedale San Raffaele
      • Ravenna, Italy
        • Azienda Unita Sanitaria Locale di Ravenna Ospedale Santa Maria delle Croci
      • Varese, Italy
        • IRCCS Ospedale di Circolo e Fondazione Macchi
    • Varese
      • Busto Arsizio, Varese, Italy
        • Ospedale di Busto Arsizio
  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Keimyung University Dongsan Medical Center
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of
        • Seoul Saint Mary's Hospital
      • Seoul, Korea, Republic of
        • Soon Chun Hyang University Hospital Seoul
    • Chungcheongnam-do
      • Daegu, Chungcheongnam-do, Korea, Republic of
        • Kyungpook National University Hospital
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of
        • National Cancer Center
      • Incheon, Gyeonggi-do, Korea, Republic of
        • Gachon University Gil Medical Center
      • Seongnam-si, Gyeonggi-do, Korea, Republic of
        • Seoul National University Bundang Hospital
    • Gyeongsangbuk-do
      • Busan, Gyeongsangbuk-do, Korea, Republic of
        • Inje University Busan Paik Hospital
    • Jeollanam-do
      • Hwasun, Jeollanam-do, Korea, Republic of
        • Chonnam National University Hwasun Hospital
  • New Zealand
      • Auckland, New Zealand
        • Auckland City Hospital
      • Christchurch, New Zealand
        • Canterbury Health Labs
    • Auckland
      • Otahuhu, Auckland, New Zealand
        • Middlemore Hospital
  • Poland
    • Dolnoslaskie
      • Legnica, Dolnoslaskie, Poland
        • Wojewodzki Szpital Specjalistyczny w Legnicy
    • Lodzkie
      • Łódź, Lodzkie, Poland
        • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi
    • Lubelskie
      • Lublin, Lubelskie, Poland
        • Centrum Onkologii Ziemi Lubelskiej
    • Malopolskie
      • Kraków, Malopolskie, Poland
        • Pratia MCM Krakow
    • Opolskie
      • Opole, Opolskie, Poland
        • Szpital Wojewodzki w Opolu
    • Pomorskie
      • Gdańsk, Pomorskie, Poland
        • Uniwersyteckie Centrum Kliniczne
    • Slaskie
      • Gliwice, Slaskie, Poland
        • Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie - Oddział w Gliwicach
  • Russian Federation
      • Kemerovo, Russian Federation
        • Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev
      • Moscow, Russian Federation, 115478
        • N. N. Blokhin Russian Cancer Research Center
      • Nizhny Novgorod, Russian Federation
        • Nizhniy Novgorod Regional Clinical Hospital N.A.
      • Rostov, Russian Federation, 344022
        • Rostov State Medical University
      • Saint Petersburg, Russian Federation
        • FGU Russian Scientific Research Institute of Hematology and Transfusiology
      • Sochi, Russian Federation
        • State Healthcare Institution Oncologic Dispensary No. 2 - Health Department of Krasnodar Region
      • Tula, Russian Federation
        • Tula Area Clinical Hospital
      • Volgograd, Russian Federation, 400138
        • State Budgetary Healthcare Institution. Volgograd
      • Yekaterinburg, Russian Federation
        • Central City Hospital # 7
  • Spain
      • Cadiz, Spain
        • Hospital Universitario Puerta Del Mar
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain
        • MD Anderson Cancer Center
      • Salamanca, Spain
        • Hospital Universitario de Salamanca
      • Zaragoza, Spain
        • Hospital de Día Quirónsalud Zaragoza
    • Barcelona
      • L'Hospitalet De Llobregat, Barcelona, Spain
        • Institut Català d'Oncologia de l'Hospitalet de Llobregat
    • Madrid
      • Majadahonda, Madrid, Spain
        • Hospital Universitario Puerta de Hierro - Majadahonda
      • Pozuelo de Alarcón, Madrid, Spain
        • Hospital Universitario Quirónsalud Madrid
  • Taiwan
      • Changhua, Taiwan
        • Changhua Christian Hospital
      • Kaohsiung, Taiwan
        • Kaohsiung Medical University Hospital
      • New Taipei City, Taiwan
        • Taipei Medical University - Shuang Ho Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • E-DA hospital
    • Tainan CITY
      • Tainan, Tainan CITY, Taiwan
        • National Cheng Kung University Hospital
  • United Kingdom
      • Leeds, United Kingdom
        • The Leeds Teaching Hospitals Nhs Trust
      • Norwich, United Kingdom
        • Norfolk and Norwich University Hospitals NHS Foundation Trust
    • England
      • Bournemouth, England, United Kingdom
        • The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
      • London, England, United Kingdom
        • Barts Health NHS Trust
      • London, England, United Kingdom
        • Sarah Cannon Research Institute London
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60612
        • University of Illinois Hospital & Health Sciences System
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89014
        • Comprehensive Cancer Centers
    • New Jersey
      • Florham Park, New Jersey, United States, 07932
        • Summit Medical Group, PA
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Histologically confirmed diagnosis of B-cell follicular lymphoma
  2. ≥2 prior systemic treatments for follicular lymphoma.
  3. Previously received an anti-CD20 antibody and an appropriate alkylator-based combination therapy.
  4. Disease progression after completion of most recent therapy or refractory disease.
  5. Presence of measurable disease.
  6. Availability of archival tissue confirming diagnosis.
  7. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
  8. Adequate renal and hepatic function.

Key Exclusion Criteria:

  1. Prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor.
  2. Known central nervous system involvement by leukemia or lymphoma.
  3. Evidence of transformation from follicular lymphoma to other aggressive histology.
  4. Allogeneic hematopoietic stem cell transplantation within 12 months of enrollment
  5. 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
  6. Clinically significant cardiovascular disease.
  7. Major surgery or significant injury ≤ 4 weeks prior to start of study treatment.
  8. Active fungal, bacterial or viral infection requiring systemic treatment.
  9. History of severe bleeding disorder.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Approximately 140 subjects to receive BGB-3111 and obinutuzumab
Drug: Zanubrutinib
BGB-3111 will be administered as two 80-mg capsules by mouth twice a day (160 mg twice a day)
Other Names:
  • Brukinsa
  • BGB-3111
Drug: Obinutuzumab
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.
Other Names:
  • Gazyva
Experimental: Arm B
Approximately 70 subjects to receive obinutuzumab
Drug: Obinutuzumab
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.
Other Names:
  • Gazyva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate (ORR) as Assessed by Independent Central Review
Time Frame: up to 3 years
up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR) as Assessed by the Investigator
Time Frame: up to 3 years
up to 3 years
Duration of response (DOR)
Time Frame: up to 3 years
up to 3 years
Progression free survival (PFS)
Time Frame: up to 3 years
up to 3 years
Overall Survival (OS)
Time Frame: up to 3 years
up to 3 years
Complete Response Rate
Time Frame: up to 3 years
up to 3 years
Complete Metabolic Response Rate
Time Frame: up to 3 years
up to 3 years
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
up to 3 years
Health-Related Quality of Life (HRQOL) as Assessed by The 5-level EQ-5D version (EQ-5D-5L)
Time Frame: up to 3 years
up to 3 years
Time to response (TTR)
Time Frame: up to 3 years
up to 3 years
Occurrence and severity of treatment-emergent adverse events (TEAEs)
Time Frame: up to 3 years
Safety and Tolerability
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BeiGene

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.
  • 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
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2017

Primary Completion (Actual)

June 25, 2022

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

October 31, 2017

First Submitted That Met QC Criteria

November 1, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BGB-3111-212
  • 2017-001552-54 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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