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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03332017
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
BeiGene

Brief Summary:
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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 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 15, 2017
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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:
  • BGB-3111
  • Brukinsa

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 Name: 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 Name: Gazyva




Primary Outcome Measures :
  1. Overall response rate (ORR) as Assessed by Independent Central Review [ Time Frame: up to 3 years ]

Secondary Outcome Measures :
  1. Overall response rate (ORR) as Assessed by the Investigator [ Time Frame: up to 3 years ]
  2. Duration of response (DOR) [ Time Frame: up to 3 years ]
  3. Progression free survival (PFS) [ Time Frame: up to 3 years ]
  4. Overall Survival (OS) [ Time Frame: up to 3 years ]
  5. Complete Response Rate [ Time Frame: up to 3 years ]
  6. Complete Metabolic Response Rate [ Time Frame: up to 3 years ]
  7. 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 ]
  8. Health-Related Quality of Life (HRQOL) as Assessed by The 5-level EQ-5D version (EQ-5D-5L) [ Time Frame: up to 3 years ]
  9. Time to response (TTR) [ Time Frame: up to 3 years ]
  10. Occurrence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: up to 3 years ]
    Safety and Tolerability



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (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
  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.


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


Contacts
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Contact: BeiGene +1-877-828-5568 clinicaltrials@beigene.com

Locations
Show Show 129 study locations
Sponsors and Collaborators
BeiGene
Investigators
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Study Director: William Reed, MD BeiGene
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03332017    
Other Study ID Numbers: BGB-3111-212
2017-001552-54 ( EudraCT Number )
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
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
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action