Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE October 31, 2017
First Posted Date  ICMJE November 6, 2017
Last Update Posted Date August 13, 2020
Actual Study Start Date  ICMJE November 15, 2017
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2020)
Overall response rate (ORR) as Assessed by Independent Central Review [ Time Frame: up to 3 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 1, 2017)
Objective response rate (ORR) [ Time Frame: up to 3 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2020)
  • Overall response rate (ORR) as Assessed by the Investigator [ Time Frame: up to 3 years ]
  • Duration of response (DOR) [ Time Frame: up to 3 years ]
  • Progression free survival (PFS) [ Time Frame: up to 3 years ]
  • Overall Survival (OS) [ Time Frame: up to 3 years ]
  • Complete Response Rate [ Time Frame: up to 3 years ]
  • Complete Metabolic Response Rate [ Time Frame: up to 3 years ]
  • 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 ]
  • Health-Related Quality of Life (HRQOL) as Assessed by The 5-level EQ-5D version (EQ-5D-5L) [ Time Frame: up to 3 years ]
  • Time to response (TTR) [ Time Frame: up to 3 years ]
  • Occurrence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: up to 3 years ]
    Safety and Tolerability
Original Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2017)
  • Progression free survival (PFS) [ Time Frame: up to 3 years ]
  • Duration of response (DOR) [ Time Frame: up to 3 years ]
  • Time to response (TTR) [ Time Frame: up to 3 years ]
  • Incidence, timing, severity of treatment-emergent AEs [ Time Frame: up to 3 years ]
    Safety and Tolerability
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma
Official Title  ICMJE An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined With Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/ Refractory Follicular Lymphoma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsed/Refractory Follicular Non-Hodgkin Lymphoma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Arm A
    Approximately 140 subjects to receive BGB-3111 and obinutuzumab
    Interventions:
    • Drug: Zanubrutinib
    • Drug: Obinutuzumab
  • Experimental: Arm B
    Approximately 70 subjects to receive obinutuzumab
    Intervention: Drug: Obinutuzumab
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 1, 2017)
210
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BeiGene +1-877-828-5568 clinicaltrials@beigene.com
Listed Location Countries  ICMJE Australia,   Belarus,   Bulgaria,   Canada,   China,   Czechia,   France,   Germany,   Italy,   Korea, Republic of,   New Zealand,   Poland,   Russian Federation,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03332017
Other Study ID Numbers  ICMJE BGB-3111-212
2017-001552-54 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party BeiGene
Study Sponsor  ICMJE BeiGene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: William Reed, MD BeiGene
PRS Account BeiGene
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP