Relapsed/Refractory Follicular Non-Hodgkin Lymphoma Clinical Trial
— ROSEWOODOfficial title:
An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined With Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/ Refractory Follicular Lymphoma
| Verified date | April 2024 |
| Source | BeiGene |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
he purpose of the study is to evaluate the efficacy, safety, and tolerability BGB-3111 plus obinutuzumab versus obinutuzumab alone in participants with relapsed/refractory non-Hodgkin follicular lymphoma.
| Status | Active, not recruiting |
| Enrollment | 217 |
| Est. completion date | October 31, 2024 |
| Est. primary completion date | October 8, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 cancer. 6. Clinically significant cardiovascular disease. 7. Major surgery = 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. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Royal Adelaide Hospital | Adelaide | South Australia |
| Australia | Icon Cancer Care - Wesley | Auchenflower | Queensland |
| Australia | Monash Health | Clayton | Victoria |
| Australia | Concord Repatriation General Hospital | Concord | New South Wales |
| Australia | Saint Vincent's Hospital Sydney | Darlinghurst | New South Wales |
| Australia | Saint Vincent's Hospital Melbourne | Fitzroy | Victoria |
| Australia | Peninsula Private Hospital | Frankston | Victoria |
| Australia | The Canberra Hospital | Garran | |
| Australia | Royal Perth Hospital | Perth | Western Australia |
| Australia | Icon Cancer Care South Brisbane | South Brisbane | Queensland |
| Australia | Calvary Mater Newcastle Hospital | Waratah | New South Wales |
| Australia | Westmead Hospital | Westmead | New South Wales |
| Belarus | Gomel Regional Clinical Oncology Dispensary | Gomel | |
| Belarus | Minsk City Clinical Oncological Dispensary | Minsk | |
| Belarus | N.N. Alexandrov National Cancer Centre of Belarus | Minsk | |
| Belarus | Vitebsk Regional Clinical Oncology Dispensary | Vitebsk | |
| Bulgaria | University Multiprofile Hospital for Active Treatment | Pleven | |
| Bulgaria | Acibadem City Clinic MHAT Tokuda | Sofia | |
| Bulgaria | University Multiprofile Hospital for Active Treatment Alexandrovska | Sofia | Sofiya-grad |
| Bulgaria | University Multiprofile Hospital for Active Treatment Saint Ivan Rilski | Sofia | Sofiya |
| Canada | Jewish General Hospital | Montréal | Quebec |
| Canada | The Ottawa Hospital | Ottawa | Ontario |
| China | Beijing Cancer Hospital | Beijing | |
| China | Peking University People Hospital | Beijing | Beijing |
| China | Peking University Third Hospital | Beijing | |
| China | West China Hospital ,Sichuan University | Chengdu | Sichuan |
| China | Second Affiliated Hospital of Army Medical University, PLA (Xinqiao Hospital) | Chongqing | |
| China | Guangdong General Hospital | Guangzhou | |
| China | Nanfang Hospital,Southern Medical University | Guangzhou | Guangzhou |
| China | The First Affiliated Hospital of College of Medicine, Zhejiang University | Hangzhou | Zhejiang |
| China | Harbin Medical University Cancer Hospital | Heilongjiang | |
| China | Henan Cancer Hospital | Henan | |
| China | Jiangsu Province Hospital | Nanjing | Jiangsu |
| China | Fudan University Shanghai Cancer Center | Shanghai | Shanghai |
| China | Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin |
| China | Tongji Hospital of Tongji Medical College Huazhong University of Science Technology | Wuhan | Hubei |
| China | Zhejiang Cancer Hospital | Zhejiang | |
| Czechia | Fakultní Nemocnice Brno | Brno | Jihormoravsky KRAJ |
| Czechia | Fakultni Nemocnice Hradec Králové | Hradec Králové 5 | Vychodocesky KRAJ |
| Czechia | Všeobecná Fakultní Nemocnice v Praze | Praha 2 | Praha |
| France | Centre Hospitalier Universitaire d'Amiens - Hopital Sud | Amiens Cedex 1 | Picardie |
| France | Centre de Lutte Contre le Cancer - Institut Bergonie | Bordeaux Cedex | Aquitaine |
| France | Centre Hospitalier de Dunkerque | Dunkerque | Nord-pas-de-calais |
| France | Clinic Louis Pasteur | Essey-lès-Nancy | Limousin, Lorraine |
| France | Centre Hospitalier Lyon Sud | Lyon | Rhone-alpes |
| France | Hôpital de la Conception | Marseille Cedex 05 | Provence Alpes COTE D'azur |
| France | Hopital Necker - Enfants Malades | Paris | Ile-de-france |
| France | Hôpital Haut-Lévêque | Pessac Cedex | Aquitaine |
| France | Centre Hospitalier Universitaire de Poitier- Hopital de la Miletrie - Hopital Jean Bernard | Poitiers Cedex | Poitou-charentes |
| France | Centre Henri-Becquerel | Rouen Cedex 1 | Haute-normandie |
| France | Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois | Vandœuvre-lès-Nancy | Limousin, Lorraine |
| Germany | Klinikum Augsburg | Augsburg | Bayern |
| Germany | Robert-Bosch-Krankenhaus | Stuttgart | Baden-wuerttemberg |
| Germany | Universitätsklinikum Ulm | Ulm | Baden-wuerttemberg |
| Italy | Policlinico di Bari | Bari | |
| Italy | Policlinico Sant'Orsola Malpighi | Bologna | |
| Italy | Ospedale di Busto Arsizio | Busto Arsizio | Varese |
| Italy | Istituto Europeo di Oncologia | Milano | |
| Italy | Ospedale San Raffaele | Milano | |
| Italy | Azienda Unita Sanitaria Locale di Ravenna Ospedale Santa Maria delle Croci | Ravenna | |
| Italy | IRCCS Ospedale di Circolo e Fondazione Macchi | Varese | |
| Korea, Republic of | Inje University Busan Paik Hospital | Busan | Gyeongsangbuk-do |
| Korea, Republic of | Keimyung University Dongsan Medical Center | Daegu | |
| Korea, Republic of | Kyungpook National University Hospital | Daegu | Chungcheongnam-do |
| Korea, Republic of | National Cancer Center | Goyang-si | Gyeonggi-do |
| Korea, Republic of | Chonnam National University Hwasun Hospital | Hwasun | Jeollanam-do |
| Korea, Republic of | Gachon University Gil Medical Center | Incheon | Gyeonggi-do |
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do |
| Korea, Republic of | Korea University Anam Hospital | Seoul | |
| Korea, Republic of | Samsung Medical Center | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | Seoul Saint Mary's Hospital | Seoul | |
| Korea, Republic of | Severance Hospital, Yonsei University Health System | Seoul | |
| Korea, Republic of | Soon Chun Hyang University Hospital Seoul | Seoul | |
| New Zealand | Auckland City Hospital | Auckland | |
| New Zealand | Canterbury Health Labs | Christchurch | |
| New Zealand | Middlemore Hospital | Otahuhu | Auckland |
| Poland | Uniwersyteckie Centrum Kliniczne | Gdansk | Pomorskie |
| Poland | Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie - Oddzial w Gliwicach | Gliwice | Slaskie |
| Poland | Pratia MCM Kraków | Kraków | Malopolskie |
| Poland | Wojewódzki Szpital Specjalistyczny w Legnicy | Legnica | Dolnoslaskie |
| Poland | Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi | Lódz | Lodzkie |
| Poland | Centrum Onkologii Ziemi Lubelskiej | Lublin | Lubelskie |
| Poland | Szpital Wojewódzki w Opolu | Opole | Opolskie |
| Russian Federation | Kemerovo Regional Clinical Hospital n.a. S.V. Belyaev | Kemerovo | |
| Russian Federation | N. N. Blokhin Russian Cancer Research Center | Moscow | |
| Russian Federation | Nizhniy Novgorod Regional Clinical Hospital N.A. | Nizhny Novgorod | |
| Russian Federation | Rostov State Medical University | Rostov | |
| 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 | Volgograd | |
| Russian Federation | Central City Hospital # 7 | Yekaterinburg | |
| Spain | Hospital Universitario Puerta del Mar | Cadiz | |
| Spain | Institut Català d'Oncologia de l'Hospitalet de Llobregat | L'Hospitalet De Llobregat | Barcelona |
| Spain | Hospital Universitario 12 de Octubre | Madrid | |
| Spain | Hospital Universitario Ramón Y Cajal | Madrid | |
| Spain | MD Anderson Cancer Center | Madrid | |
| Spain | Hospital Universitario Puerta de Hierro - Majadahonda | Majadahonda | Madrid |
| Spain | Hospital Universitario Quironsalud Madrid | Pozuelo de Alarcón | Madrid |
| Spain | Hospital Universitario de Salamanca | Salamanca | |
| Spain | Hospital de Día Quirónsalud Zaragoza | Zaragoza | |
| Taiwan | Changhua Christian Hospital | Changhua | |
| Taiwan | Kaohsiung Medical University Hospital | Kaohsiung | |
| Taiwan | Taipei Medical University - Shuang Ho Hospital | New Taipei City | |
| Taiwan | National Cheng Kung University Hospital | Tainan | Tainan CITY |
| Taiwan | E-DA Hospital | Taipei | |
| Taiwan | National Taiwan University Hospital | Taipei | |
| United Kingdom | The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust | Bournemouth | England |
| United Kingdom | The Leeds Teaching Hospitals NHS Trust | Leeds | |
| United Kingdom | Barts Health NHS Trust | London | England |
| United Kingdom | Sarah Cannon Research Institute London | London | England |
| United Kingdom | Norfolk and Norwich University Hospitals NHS Foundation Trust | Norwich | |
| United States | Emory University | Atlanta | Georgia |
| United States | Northwestern University | Chicago | Illinois |
| United States | University of Illinois Hospital & Health Sciences System | Chicago | Illinois |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | Summit Medical Group, PA | Florham Park | New Jersey |
| United States | Comprehensive Cancer Centers | Las Vegas | Nevada |
| United States | Loyola University Medical Center | Maywood | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| BeiGene |
United States, Australia, Belarus, Bulgaria, Canada, China, Czechia, France, Germany, Italy, Korea, Republic of, New Zealand, Poland, Russian Federation, Spain, Taiwan, United Kingdom,
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
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.
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) by Independent Review Committee (IRC) Assessment | ORR is defined as the percentage of participants who achieve either complete response (CR) or partial response (PR) as best overall response, as assessed by the IRC using Lugano Classification for Non-Hodgkin Lymphoma | Through primary analysis data cut-off date of 08OCT2021 (up to approximately 3 years and 11 months) | |
| Secondary | Overall Response Rate (ORR) as Assessed by the Investigator | Up to approximately 7 years | ||
| Secondary | Duration of Response (DOR) | Up to approximately 7 years | ||
| Secondary | Progression Free Survival (PFS) | Up to approximately 7 years | ||
| Secondary | Overall Survival (OS) | Up to approximately 7 years | ||
| Secondary | Complete Response Rate | Up to approximately 7 years | ||
| Secondary | Complete Metabolic Response Rate | Up to approximately 7 years | ||
| Secondary | Time to Response (TTR) | Up to approximately 7 years | ||
| Secondary | 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) | Up to approximately 7 years | ||
| Secondary | Health-Related Quality of Life (HRQOL) as Assessed by The 5-level EQ-5D Version (EQ-5D-5L) | Up to approximately 7 years | ||
| Secondary | Occurrence and Severity of Treatment-emergent Adverse Events (TEAEs) | Safety and Tolerability | Up to approximately 7 years | |
| Secondary | Apparent Clearance (CL/F) of Zanubrutinib | Day 1 Cycle 1 and Day 2 Cycle 2: Predose | ||
| Secondary | Area Under the Curve From 0 to 12 Hours Post Dose (AUC0-12) | Day 1 Cycle 1 and Day 2 Cycle 2: Pre-dose |