TriangleNCT03332017 · CITED IN SOURCE DOCUMENTS
A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2026-02-18
This clinical study examined the safety and efficacy of the combination of zanubrutinib and obinutuzumab versus obinutuzumab alone in adults with follicular lymphoma whose disease returned after or did not respond to prior therapy.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Overall Response Rate (ORR) by Independent Central Review (ICR) Assessment
Overall Response Rate (ORR) as Assessed by the Investigator
Duration of Response (DOR) as Determined by Investigator Assessment
DOR as Determined by ICR
Progression-free Survival (PFS)
Overall Survival (OS)
Complete Response Rate
Time to Response (TTR)
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL), Physical Functioning, Role Functioning, and Symptom Scores
Change From Baseline in European Quality of Life 5-Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS)
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Area Under the Curve (AUCss) of Zanubrutinib at Steady State
Zanubrutinib Plasma Concentrations
Minimum Observed Concentration (Cmin) of Zanubrutinib at Steady State
Maximum Observed Concentration (Cmax) of Zanubrutinib at Steady State
Duration of Response (DOR) as Determined by ICR
DOR as Determined by Investigator
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Key Inclusion Criteria: * Participants had a histologically confirmed diagnosis of B-cell follicular lymphoma. * Participants had received two or more prior systemic treatments for follicular lymphoma. * Participants had previously received both an anti-cluster of differentiation 20 (anti-CD20) antibody and an appropriate alkylator-based combination therapy. * Participants had disease that had progressed after completion of the most recent therapy or was considered refractory to treatment. * Participants had measurable disease present. * Archival tissue confirming the diagnosis was available. * Participants had an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * Participants had adequate renal and hepatic function. Key Exclusion Criteria: * Participants had prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor. * Participants had known central nervous system involvement by leukemia or lymphoma. * Participants had evidence of transformation from follicular lymphoma to another aggressive histologic subtype. * Participants had undergone an allogeneic hematopoietic stem cell transplantation within 12 months of enrollment. * Participants had a prior malignancy within the past 2 years, except for those who had curatively treated basal cell or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized prostate cancer with a Gleason score of 6. * Participants had clinically significant cardiovascular disease. * Participants had undergone major surgery within 4 weeks prior to the start of study treatment. * Participants had an active fungal, bacterial, or viral infection requiring systemic treatment. * Participants had a history of severe bleeding disorder. Note: Other protocol-defined inclusion and exclusion criteria may have applied.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Participants received obinutuzumab 1000 milligrams (mg) intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6; and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days. Participants who experienced progressive disease or did not respond to therapy within 12 months may have received crossover treatment with zanubrutinib + obinutuzumab at the investigator's discretion.
- intervention Names
- Drug: Obinutuzumab
- label
- Obinutuzumab
- type
- EXPERIMENTAL
- description
- Participants received zanubrutinib 160 mg twice a day orally with or without food and obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6, and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days.
- intervention Names
- Drug: Zanubrutinib
- Drug: Obinutuzumab
- label
- Zanubrutinib + Obinutuzumab
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Zanubrutinib + Obinutuzumab
- description
- Oral administration as a capsule
- name
- Zanubrutinib
- other Names
- BGB-3111
- Brukinsa
- type
- DRUG
- arm Group Labels
- Obinutuzumab
- Zanubrutinib + Obinutuzumab
- description
- Intravenous administration
- name
- Obinutuzumab
- other Names
- Gazyva
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 217
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) per the Lugano Classification for Non-Hodgkin's Lymphoma.
- measure
- Overall Response Rate (ORR) by Independent Central Review (ICR) Assessment
- time Frame
- From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.
- secondary Outcomes
- description
- ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) per the Lugano Classification for Non-Hodgkin's Lymphoma.
- measure
- Overall Response Rate (ORR) as Assessed by the Investigator
- time Frame
- From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.
- description
- DOR was defined as the time from the date that a confirmed response (CR or PR) was first observed to the date of first documented disease progression or death, whichever occurred first. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the DOR calculation. Median DOR was estimated using the Kaplan-Meier method.
- measure
- Duration of Response (DOR) as Determined by Investigator Assessment
- time Frame
- From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.
- description
- DOR was defined as the time from the date that a confirmed response (CR or PR) was first observed to the date of first documented disease progression or death, whichever occurred first. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the DOR calculation. Median DOR was estimated using the Kaplan-Meier method.
- measure
- DOR as Determined by ICR
- time Frame
- From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.
- description
- PFS was defined as the time from randomization to the date of first documented disease progression or death from any cause, whichever occurred first, as determined by the ICR or investigator assessment. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the PFS calculation. Median PFS was estimated using the Kaplan-Meier method.
- measure
- Progression-free Survival (PFS)
- time Frame
- From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.
- description
- OS was defined as the time from randomization to the date of death from any cause. Median OS was estimated using the Kaplan-Meier method.
- measure
- Overall Survival (OS)
- time Frame
- From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.
- description
- CRR was defined as the percentage of participants who achieved a complete response or complete metabolic response as their best overall response, as determined by ICR and investigator assessment. Responses were assessed from randomization until the data cutoff date, the start of a new anticancer therapy, or the crossover date for participants in the monotherapy arm who switched to combination therapy.
- measure
- Complete Response Rate
- time Frame
- From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.
- description
- TRR was defined as the time from randomization to the first date that response criteria (CR or PR) were met, as determined by ICR and investigator assessment. Only participants who achieved an overall response were included in the analysis. For participants in the monotherapy arm who crossed over to combination therapy, disease assessments after crossover were not included in the TRR calculation.
- measure
- Time to Response (TTR)
- time Frame
- From first dose to primary analysis data cutoff (08OCT2021) start of a new anticancer therapy, or the crossover date, whichever came first. Median follow-up was 12.45 months.
- description
- The EORTC QLQ-C30 includes 30 questions covering 5 functional scales (physical, role, emotional, cognitive, social), 1 global health scale, 3 symptom scales (fatigue, nausea/vomiting, pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). Participants report their health over the past week. Most items use a 4-point scale (1 = Not at all to 4 = Very much), while 2 global QOL items use a 7-point scale (1 = Very poor to 7 = Excellent). Raw scores are linearly transformed to a 0-100 scale; higher GHS and functional scores and lower symptom scores indicate better quality of life.
- measure
- Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL), Physical Functioning, Role Functioning, and Symptom Scores
- time Frame
- Baseline, Week 12, and Week 24
- description
- The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.
- measure
- Change From Baseline in European Quality of Life 5-Dimensions, 5-level (EQ-5D-5L) Visual Analogue Scale (VAS)
- time Frame
- Baseline, Week 12, and Week 24
- description
- An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it is linked to the study drug.
- measure
- Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
- time Frame
- From first dose to 30 days after zanubrutinib, 90 days after obinutuzumab, or before new therapy, whichever came first, up to study cut-off (31 Dec 2024); maximum exposure was 28.7 months for obinutuzumab and 67.4 months for combination therapy.
- description
- Pharmacokinetic exposure parameters were estimated for each participant using a population pharmacokinetic (PK) model.
- measure
- Area Under the Curve (AUCss) of Zanubrutinib at Steady State
- time Frame
- Cycle 1 Day 1 and Cycle 2 Day 1: Predose (within 30 minutes before zanubrutinib dosing) and 2 hours (± 30 minutes) post-dose.
- measure
- Zanubrutinib Plasma Concentrations
- time Frame
- Cycle 1 Day 1 and Cycle 2 Day 1: Predose (within 30 minutes before zanubrutinib dosing) and 2 hours (± 30 minutes) post-dose.
Full study description
- brief Summary
- This clinical study examined the safety and efficacy of the combination of zanubrutinib and obinutuzumab versus obinutuzumab alone in adults with follicular lymphoma whose disease returned after or did not respond to prior therapy.
- detailed Description
- This study randomly assigned participants in a 2:1 ratio to receive either zanubrutinib plus obinutuzumab or obinutuzumab alone. The assignment considered how many prior treatments participants had received, whether their cancer had stopped responding to rituximab, and whether they were enrolled in Mainland China or other regions. Each treatment cycle lasted 28 days, with zanubrutinib taken by mouth twice daily and obinutuzumab given intravenously on a set schedule, followed by optional maintenance for up to 24 months. Participants who had obinutuzumab alone could have switched to the combination treatment if their disease worsened or did not respond after 12 months, if confirmed by an independent review.
Source references
- references
- 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.
- type
- BACKGROUND
- 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
- type
- BACKGROUND
- 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
- type
- BACKGROUND
- citation
- Trotman J, Zinzani PL, Song Y, et al. Health-Related Quality of Life (HRQoL) in Patients With Relapsed/Refractory Follicular Lymphoma (R/R FL) Treated With Zanubrutinib + Obinutuzumab Versus Obinutuzumab Monotherapy: The ROSEWOOD Trial. Poster presented at: 65th ASH Annual Meeting and Exposition; December, 2023; San Diego, CA. https://doi.org/10.1182/blood-2023-181195
- type
- BACKGROUND
- citation
- Judith Trotman, Pier Luigi Zinzani, Krimo Bouabdallah, Shanmei Liao, Adam Greenbaum, Laura Dima, Laurent Dumartin; Comparative Efficacy of Zanubrutinib Plus Obinutuzumab Versus Last Prior Treatment in Relapsed/Refractory Follicular Lymphoma: Growth Modulation Index Analysis from ROSEWOOD Study. Blood 2024; 144 (Supplement 1): 3029. doi: https://doi.org/10.1182/blood-2024-198500
- type
- RESULT
- citation
- Zinzani PL, Mayer J, Flowers CR, Bijou F, De Oliveira AC, Song Y, Zhang Q, Merli M, Bouabdallah K, Ganly P, Zhang H, Johnson R, Martin Garcia-Sancho A, Provencio Pulla M, Trneny M, Yuen S, Tilly H, Kingsley E, Tumyan G, Assouline SE, Auer R, Ivanova E, Kim P, Huang S, Delarue R, Trotman J. ROSEWOOD: A Phase II Randomized Study of Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma. J Clin Oncol. 2023 Nov 20;41(33):5107-5117. doi: 10.1200/JCO.23.00775. Epub 2023 Jul 28.
- pmid
- 37506346
- type
- RESULT
- citation
- Zinzani PL, Mayer J, Trotman J, et al. Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab in Patients With Relapsed/Refractory Follicular Lymphoma: Updated Analysis of the ROSEWOOD Study. Oral presentation at: 17th International Conference on Malignant Lymphoma; June, 2023; Lugano, Switzerland. https://doi.org/10.1002/hon.3163_81
- type
- RESULT
- citation
- Trotman J, Zinzani PL Mayer J, et al. Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab in Patients With Relapsed/Refractory Follicular Lymphoma: Updated Analysis of the ROSEWOOD Study. Poster presented at: European Hematology Association; June, 2023; Frankfurt, Germany.
- type
- RESULT
- citation
- Flowers CR, Zinzani PL, Mayer J, et al. Zanubrutinib Plus Obinutuzumab Versus Obinutuzumab in Patients With Relapsed or Refractory Follicular Lymphoma: Updated Analysis of the ROSEWOOD Study. Poster presented at: 2023 ASCO Annual Meeting; June, 2023; Chicago, IL. https://doi.org/10.1200/JCO.2023.41.16_suppl.7545
- type
- RESULT
- citation
- Gaballa S, Xue M, Swami S, et al. Cost-effectiveness of Zanubrutinib + Obinutuzumab for Treatment of Relapsed or Refractory Follicular Lymphoma in the United States. Poster presented at: International Society for Pharmacoeconomics and Outcomes Research Europe 2024; November, 2024; Barcelona, Spain. https://www.ispor.org/heor-resources/presentations-database/presentation/intl2024-3896/136274 http://reg2022.csco.org.cn/24?lang=en
- type
- RESULT
- citation
- Trotman J, Zinzani PL, Song Y, Delarue R, Kim P, Ivanova E, Korde R, Mayer J, De Oliveira AC, Assouline SE, Flowers CR, Barnes G. Patient-reported outcomes in patients with relapsed or refractory follicular lymphoma treated with zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy: results from the ROSEWOOD trial. Curr Med Res Opin. 2024 Nov;40(11):1863-1871. doi: 10.1080/03007995.2024.2409837. Epub 2024 Oct 14.
- pmid
- 39376156
- type
- DERIVED
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Discovery and provenance
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Preserved source evidence · Independent clinical review pending · Not medical advice