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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03332017




Registration number
NCT03332017
Ethics application status
Date submitted
31/10/2017
Date registered
6/11/2017

Titles & IDs
Public title
A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma
Scientific title
An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined With Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/ Refractory Follicular Lymphoma
Secondary ID [1] 0 0
2017-001552-54
Secondary ID [2] 0 0
BGB-3111-212
Universal Trial Number (UTN)
Trial acronym
ROSEWOOD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed/Refractory Follicular Non-Hodgkin Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Zanubrutinib
Treatment: Drugs - Obinutuzumab

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

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


Treatment: Drugs: Zanubrutinib
Oral administration as a capsule

Treatment: Drugs: Obinutuzumab
Intravenous administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Response Rate (ORR) by Independent Review Committee (IRC) Assessment
Timepoint [1] 0 0
Through primary analysis data cut-off date of 08OCT2021 (up to approximately 3 years and 11 months)
Secondary outcome [1] 0 0
Overall Response Rate (ORR) as Assessed by the Investigator
Timepoint [1] 0 0
Up to approximately 7 years
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
Up to approximately 7 years
Secondary outcome [3] 0 0
Progression Free Survival (PFS)
Timepoint [3] 0 0
Up to approximately 7 years
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
Up to approximately 7 years
Secondary outcome [5] 0 0
Complete Response Rate
Timepoint [5] 0 0
Up to approximately 7 years
Secondary outcome [6] 0 0
Complete Metabolic Response Rate
Timepoint [6] 0 0
Up to approximately 7 years
Secondary outcome [7] 0 0
Time to Response (TTR)
Timepoint [7] 0 0
Up to approximately 7 years
Secondary outcome [8] 0 0
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)
Timepoint [8] 0 0
Up to approximately 7 years
Secondary outcome [9] 0 0
Health-Related Quality of Life (HRQOL) as Assessed by The 5-level EQ-5D Version (EQ-5D-5L)
Timepoint [9] 0 0
Up to approximately 7 years
Secondary outcome [10] 0 0
Occurrence and Severity of Treatment-emergent Adverse Events (TEAEs)
Timepoint [10] 0 0
Up to approximately 7 years
Secondary outcome [11] 0 0
Apparent Clearance (CL/F) of Zanubrutinib
Timepoint [11] 0 0
Day 1 Cycle 1 and Day 2 Cycle 2: Predose
Secondary outcome [12] 0 0
Area Under the Curve From 0 to 12 Hours Post Dose (AUC0-12)
Timepoint [12] 0 0
Day 1 Cycle 1 and Day 2 Cycle 2: Pre-dose

Eligibility
Key inclusion criteria
Key

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
Accrual to date
Final
217
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment hospital [5] 0 0
Icon Cancer Centre Wesley - Auchenflower
Recruitment hospital [6] 0 0
Monash Health - Clayton
Recruitment hospital [7] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [8] 0 0
Peninsula Private Hospital - Frankston
Recruitment hospital [9] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4066 - Auchenflower
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy
Recruitment postcode(s) [8] 0 0
3199 - Frankston
Recruitment postcode(s) [9] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Nevada
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
Belarus
State/province [5] 0 0
Minsk
Country [6] 0 0
Belarus
State/province [6] 0 0
Vitebsk
Country [7] 0 0
Bulgaria
State/province [7] 0 0
Pleven
Country [8] 0 0
Bulgaria
State/province [8] 0 0
Sofia
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
Canada
State/province [10] 0 0
Quebec
Country [11] 0 0
China
State/province [11] 0 0
Beijing
Country [12] 0 0
China
State/province [12] 0 0
Guangdong
Country [13] 0 0
China
State/province [13] 0 0
Heilongjiang
Country [14] 0 0
China
State/province [14] 0 0
Henan
Country [15] 0 0
China
State/province [15] 0 0
Hubei
Country [16] 0 0
China
State/province [16] 0 0
Jiangsu
Country [17] 0 0
China
State/province [17] 0 0
Shanghai
Country [18] 0 0
China
State/province [18] 0 0
Sichuan
Country [19] 0 0
China
State/province [19] 0 0
Tianjin
Country [20] 0 0
China
State/province [20] 0 0
Zhejiang
Country [21] 0 0
Czechia
State/province [21] 0 0
Brno
Country [22] 0 0
Czechia
State/province [22] 0 0
Hradec Kralove
Country [23] 0 0
Czechia
State/province [23] 0 0
Praha
Country [24] 0 0
France
State/province [24] 0 0
Amiens Cedex
Country [25] 0 0
France
State/province [25] 0 0
Bordeaux
Country [26] 0 0
France
State/province [26] 0 0
Dunkerque
Country [27] 0 0
France
State/province [27] 0 0
Esseylesnancy
Country [28] 0 0
France
State/province [28] 0 0
Paris
Country [29] 0 0
France
State/province [29] 0 0
Pessac
Country [30] 0 0
France
State/province [30] 0 0
PierreBenite
Country [31] 0 0
France
State/province [31] 0 0
Poitiers
Country [32] 0 0
France
State/province [32] 0 0
Rouen Cedex
Country [33] 0 0
Germany
State/province [33] 0 0
Augsburg
Country [34] 0 0
Italy
State/province [34] 0 0
Bari
Country [35] 0 0
Italy
State/province [35] 0 0
Bologna
Country [36] 0 0
Italy
State/province [36] 0 0
Milano
Country [37] 0 0
Italy
State/province [37] 0 0
Ravenna
Country [38] 0 0
Italy
State/province [38] 0 0
Varese
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Daegu Gwang'yeogsi
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Gyeonggi-do
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Seoul Teugbyeolsi
Country [42] 0 0
New Zealand
State/province [42] 0 0
Auckland
Country [43] 0 0
New Zealand
State/province [43] 0 0
Christchurch
Country [44] 0 0
Poland
State/province [44] 0 0
Krakow
Country [45] 0 0
Poland
State/province [45] 0 0
Lodz
Country [46] 0 0
Poland
State/province [46] 0 0
Lublin
Country [47] 0 0
Poland
State/province [47] 0 0
Opole
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Krasnodarskiy Kray
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Moskva
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Sverdlovskaya Oblast'
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Tul'skaya Oblast'
Country [52] 0 0
Spain
State/province [52] 0 0
Barcelona
Country [53] 0 0
Spain
State/province [53] 0 0
Cadiz
Country [54] 0 0
Spain
State/province [54] 0 0
Madrid
Country [55] 0 0
Spain
State/province [55] 0 0
Majadahonda
Country [56] 0 0
Spain
State/province [56] 0 0
Pozuelo de Alarcon
Country [57] 0 0
Spain
State/province [57] 0 0
Salamanca
Country [58] 0 0
Taiwan
State/province [58] 0 0
Kaohsiung
Country [59] 0 0
Taiwan
State/province [59] 0 0
New Taipei City
Country [60] 0 0
Taiwan
State/province [60] 0 0
Tainan
Country [61] 0 0
Taiwan
State/province [61] 0 0
Taipei
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Bournemouth
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Leeds
Country [64] 0 0
United Kingdom
State/province [64] 0 0
London
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Norwich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03332017