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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03332017
Recruitment Status : Active, not recruiting
First Posted : November 6, 2017
Results First Posted : April 30, 2024
Last Update Posted : April 30, 2024
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Relapsed/Refractory Follicular Non-Hodgkin Lymphoma Drug: Zanubrutinib Drug: Obinutuzumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 217 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 14, 2017
Actual Primary Completion Date : October 8, 2021
Estimated Study Completion Date : October 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Obinutuzumab
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 until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; each cycle is 28 days
 Drug: Obinutuzumab
Intravenous administration
Other Name: Gazyva
Experimental: Zanubrutinib + Obinutuzumab
Zanubrutinib 160 mg twice a day orally with or without food; 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 until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; each cycle is 28 days
 Drug: Zanubrutinib
Oral administration as a capsule
Other Names:
  • BGB-3111
  • Brukinsa

Drug: Obinutuzumab
Intravenous administration
Other Name: Gazyva


Outcome Measures
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Primary Outcome Measures :
  1. Overall Response Rate (ORR) by Independent Review Committee (IRC) Assessment [ Time Frame: Through primary analysis data cut-off date of 08OCT2021 (up to approximately 3 years and 11 months) ]
    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


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) as Assessed by the Investigator [ Time Frame: Up to approximately 7 years ]
  2. Duration of Response (DOR) [ Time Frame: Up to approximately 7 years ]
  3. Progression Free Survival (PFS) [ Time Frame: Up to approximately 7 years ]
  4. Overall Survival (OS) [ Time Frame: Up to approximately 7 years ]
  5. Complete Response Rate [ Time Frame: Up to approximately 7 years ]
  6. Complete Metabolic Response Rate [ Time Frame: Up to approximately 7 years ]
  7. Time to Response (TTR) [ Time Frame: Up to approximately 7 years ]
  8. 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 approximately 7 years ]
  9. Health-Related Quality of Life (HRQOL) as Assessed by The 5-level EQ-5D Version (EQ-5D-5L) [ Time Frame: Up to approximately 7 years ]
  10. Occurrence and Severity of Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 7 years ]
    Safety and Tolerability

  11. Apparent Clearance (CL/F) of Zanubrutinib [ Time Frame: Day 1 Cycle 1 and Day 2 Cycle 2: Predose ]
  12. Area Under the Curve From 0 to 12 Hours Post Dose (AUC0-12) [ Time Frame: Day 1 Cycle 1 and Day 2 Cycle 2: Pre-dose ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03332017


Locations
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Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Study Director BeiGene
  Study Documents (Full-Text)

Documents provided by BeiGene:
Study Protocol  [PDF] August 18, 2021
Statistical Analysis Plan  [PDF] November 12, 2021

More Information
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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

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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03332017    
Other Study ID Numbers: BGB-3111-212
2017-001552-54 ( EudraCT Number )
CTR20220712 ( Other Identifier: ChinaDrugTrials )
First Posted: November 6, 2017    Key Record Dates
Results First Posted: April 30, 2024
Last Update Posted: April 30, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BeiGene:
Relapsed/Refractory Follicular non-Hodgkin Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Obinutuzumab
Zanubrutinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Tyrosine Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action