Clinical trial · Interventional
A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma
An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined With Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/ Refractory Follicular Lymphoma
NCT03332017CI-TRIAL-00103565ROSEWOODcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory Follicular Non-Hodgkin Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Obinutuzumab | Drug | Obinutuzumab | ALIAS |
| Zanubrutinib | Drug | Zanubrutinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Obinutuzumab
- 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.
- interventionNames
- Drug: Obinutuzumab
- type
- EXPERIMENTAL
- label
- Zanubrutinib + Obinutuzumab
- 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.
- interventionNames
- Drug: Zanubrutinib
- Drug: Obinutuzumab
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (11)
- BACKGROUNDTrotman 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.
- BACKGROUNDFowler 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
- BACKGROUNDFowler 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
- BACKGROUNDTrotman 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
- RESULTJudith 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
- RESULTZinzani 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
- RESULTZinzani 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