Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05100862
Registration number
NCT05100862
Ethics application status
Date submitted
27/09/2021
Date registered
29/10/2021
Titles & IDs
Public title
A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
Query!
Scientific title
A Phase 3 Randomized, Open-Label Multicenter Study of Zanubrutinib (BGB-3111) Plus Anti-CD20 Antibodies Versus Lenalidomide Plus Rituximab in Patients With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
Query!
Secondary ID [1]
0
0
CTR20232545
Query!
Secondary ID [2]
0
0
BGB-3111-308
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
MAHOGANY
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Relapsed/Refractory Follicular Lymphoma
0
0
Query!
Marginal Zone Lymphoma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Query!
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Zanubrutinib
Treatment: Drugs - Rituximab
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Obinutuzumab
Experimental: Follicular Lymphoma Arm A: Zanubrutinib plus Obinutuzumab - Participants will receive zanubrutinib and Obinutuzumab. Following the completion of the combination treatment, participants will continue receiving zanubrutinib monotherapy until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination, whichever occurs first.
Active comparator: Follicular Lymphoma Arm B: Lenalidomide plus Rituximab - Participants will receive lenalidomide and rituximab.
Experimental: Marginal Zone Lymphoma Arm C: Zanubrutinib plus Rituximab - Participants will receive zanubrutinib and rituximab. Following the completion of the combination treatment, participants will continue receiving zanubrutinib monotherapy until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination, whichever occurs first.
Active comparator: Marginal Zone Lymphoma Arm D: Lenalidomide plus Rituximab - Participants will receive lenalidomide and rituximab.
Treatment: Drugs: Zanubrutinib
Zanubrutinib will be administered orally as two 80-milligram (mg) capsules twice a day (160 mg twice a day) or four 80-mg capsules once a day (320 mg once a day) continuously in repeated 28-day cycles.
Treatment: Drugs: Rituximab
Rituximab will be administered intravenously at a dose of 375 mg/meter squared on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. Each cycle is 28 days in length.
Treatment: Drugs: Lenalidomide
Lenalidomide will be administered orally as 20-mg capsules (10 mg if creatinine clearance = 30 mL/min but \< 60 mL/min) once a day on Days 1 to 21 of each 28-day cycle for a total of 12 cycles.
Treatment: Drugs: Obinutuzumab
Obinutuzumab will be administered at a dose of 1000 mg on Cycle 1 Days 1, 8, 15 and then on Cycles 2 to 6 Day 1.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Progression-free Survival As Determined By A Blinded Independent Review Committee (BIRC)
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Approximately 78 months
Query!
Secondary outcome [1]
0
0
Progression-free Survival As Determined By Investigator Assessment
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Approximately 87 months
Query!
Secondary outcome [2]
0
0
Duration Of Response As Determined By BIRC And By Investigator Assessment
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Approximately 87 months
Query!
Secondary outcome [3]
0
0
Overall Response Rate As Determined By BIRC And By Investigator Assessment
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Approximately 87 months
Query!
Secondary outcome [4]
0
0
Complete Response Rate As Determined By BIRC And By Investigator Assessment
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
Approximately 87 months
Query!
Secondary outcome [5]
0
0
Time To Response As Determined By BIRC And By Investigator Assessment
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Approximately 87 months
Query!
Secondary outcome [6]
0
0
Time to Next Ant-Lymphoma Treatment
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
Approximately 87 months
Query!
Secondary outcome [7]
0
0
Overall Survival
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
Approximately 87 months
Query!
Secondary outcome [8]
0
0
Health-related Quality Of Life (HRQoL) Using EORTC QLQ-C30)
Query!
Assessment method [8]
0
0
HRQ0L assessed by The European Organization For Research On Treatment Of Cancer Quality Of Life Questionnaire-core 30 (EORTC QLQ-C30) consists of 30 questions that are associated with 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), and 6 single symptom items ( dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The scores range from 0 to 100 and higher score indicates better quality of life.
Query!
Timepoint [8]
0
0
Approximately 87 months
Query!
Secondary outcome [9]
0
0
HRQoL Using European Quality of Life 5 Dimension 5 Level Questionnaire [EQ 5D 5L)
Query!
Assessment method [9]
0
0
The EQ-5D-5L is comprised of a descriptive module and a visual analogue scale. The EQ-5D-5L descriptive module comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogue scale records the respondent's self-rated health on a 0 to 100 scale, with 100 labeled "the best health you can imagine" and 0 labeled "the worst health you can imagine. Higher scores indicate better quality of life.
Query!
Timepoint [9]
0
0
Approximately 87 months
Query!
Secondary outcome [10]
0
0
HRQoL Using National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 [FLymSI 18)
Query!
Assessment method [10]
0
0
The FLymSI-18 is comprised of 18 questions which cover 4 sub-scales: physical symptoms, emotional symptoms, side effects, and functional well-being. Scores are based on the 5-level Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and is divided into a total score. Higher score indicates better quality of life.
Query!
Timepoint [10]
0
0
Approximately 87 months
Query!
Secondary outcome [11]
0
0
Number of Participants Experiencing Adverse Events (AEs)
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
From first dose to 28 days after the last dose of zanubrutinib or lenalidomide, 90 days after the last dose of obinutuzumab or rituximab, or until the date of confirmed disease progression, whichever comes later (Approximately 87 months)
Query!
Eligibility
Key inclusion criteria
Key
* Histologically confirmed grade 1-3a FL or MZL
* Previously treated with = 1 line of systemic therapy including anti-CD20 agent. Must have a documented failure to achieve at least partial response during the most recent systemic therapy or documented progressive disease after the most recent systemic therapy
* Need for systemic therapy for FL or MZL
* Measurable disease by computed tomography or magnetic resonance imaging
* Adequate bone marrow, liver and renal function
Key
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Transformation to aggressive lymphoma
* Requiring ongoing need for corticosteroid treatment
* Clinically significant cardiovascular disease
* Prior malignancy within the past 2 years
* Active fungal, bacterial, and/or viral infection that requires systemic therapy
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
10/03/2022
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/06/2030
Query!
Actual
Query!
Sample size
Target
750
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Query!
Recruitment hospital [1]
0
0
Concord Repatriation General Hospital - Concord
Query!
Recruitment hospital [2]
0
0
Gosford Hospital - Gosford
Query!
Recruitment hospital [3]
0
0
St George Hospital - Kogarah
Query!
Recruitment hospital [4]
0
0
Orange Health Hospital - Orange
Query!
Recruitment hospital [5]
0
0
Port Macquarie Base Hospital - Port Macquarie
Query!
Recruitment hospital [6]
0
0
Westmead Hospital - Westmead
Query!
Recruitment hospital [7]
0
0
Sunshine Coast Hospital and Health Service - Birtinya
Query!
Recruitment hospital [8]
0
0
Townsville University Hospital - Douglas
Query!
Recruitment hospital [9]
0
0
Monash Health - Clayton
Query!
Recruitment hospital [10]
0
0
St Vincents Hospital Melbourne - Fitzroy
Query!
Recruitment hospital [11]
0
0
Austin Health - Heidelberg
Query!
Recruitment hospital [12]
0
0
Cabrini Hospital Malvern - Malvern
Query!
Recruitment hospital [13]
0
0
Epworth Freemasons - Melbourne
Query!
Recruitment hospital [14]
0
0
The Alfred Hospital - Melbourne
Query!
Recruitment hospital [15]
0
0
Royal Perth Hospital - Perth
Query!
Recruitment hospital [16]
0
0
Perth Blood Institute - West Perth
Query!
Recruitment hospital [17]
0
0
La Trobe Regional Hospital - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2139 - Concord
Query!
Recruitment postcode(s) [2]
0
0
2250 - Gosford
Query!
Recruitment postcode(s) [3]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [4]
0
0
2800 - Orange
Query!
Recruitment postcode(s) [5]
0
0
2444 - Port Macquarie
Query!
Recruitment postcode(s) [6]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [7]
0
0
4575 - Birtinya
Query!
Recruitment postcode(s) [8]
0
0
4814 - Douglas
Query!
Recruitment postcode(s) [9]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [10]
0
0
3065 - Fitzroy
Query!
Recruitment postcode(s) [11]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [12]
0
0
3144 - Malvern
Query!
Recruitment postcode(s) [13]
0
0
3002 - Melbourne
Query!
Recruitment postcode(s) [14]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [15]
0
0
6000 - Perth
Query!
Recruitment postcode(s) [16]
0
0
6005 - West Perth
Query!
Recruitment postcode(s) [17]
0
0
3844 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Florida
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Georgia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Indiana
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Iowa
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Kansas
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Kentucky
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Maryland
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Michigan
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Mississippi
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Missouri
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Montana
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Nebraska
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Nevada
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New Jersey
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New York
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
North Carolina
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Ohio
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Pennsylvania
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
South Dakota
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Texas
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Washington
Query!
Country [23]
0
0
Argentina
Query!
State/province [23]
0
0
Buenos Aires
Query!
Country [24]
0
0
Argentina
Query!
State/province [24]
0
0
Caba
Query!
Country [25]
0
0
Austria
Query!
State/province [25]
0
0
St Poelten
Query!
Country [26]
0
0
Austria
Query!
State/province [26]
0
0
Vienna
Query!
Country [27]
0
0
Austria
Query!
State/province [27]
0
0
Wien
Query!
Country [28]
0
0
Belgium
Query!
State/province [28]
0
0
Anderlecht
Query!
Country [29]
0
0
Belgium
Query!
State/province [29]
0
0
Brugge
Query!
Country [30]
0
0
Belgium
Query!
State/province [30]
0
0
Gent
Query!
Country [31]
0
0
Belgium
Query!
State/province [31]
0
0
Leuven
Query!
Country [32]
0
0
Brazil
Query!
State/province [32]
0
0
Barretos
Query!
Country [33]
0
0
Brazil
Query!
State/province [33]
0
0
Blumenau
Query!
Country [34]
0
0
Brazil
Query!
State/province [34]
0
0
Botucatu
Query!
Country [35]
0
0
Brazil
Query!
State/province [35]
0
0
Brasilia
Query!
Country [36]
0
0
Brazil
Query!
State/province [36]
0
0
Campinas
Query!
Country [37]
0
0
Brazil
Query!
State/province [37]
0
0
Caxias do Sul
Query!
Country [38]
0
0
Brazil
Query!
State/province [38]
0
0
Curitiba
Query!
Country [39]
0
0
Brazil
Query!
State/province [39]
0
0
Florianopolis
Query!
Country [40]
0
0
Brazil
Query!
State/province [40]
0
0
Porto Alegre
Query!
Country [41]
0
0
Brazil
Query!
State/province [41]
0
0
Porto Velho
Query!
Country [42]
0
0
Brazil
Query!
State/province [42]
0
0
Recife
Query!
Country [43]
0
0
Brazil
Query!
State/province [43]
0
0
Ribeirao Preto
Query!
Country [44]
0
0
Brazil
Query!
State/province [44]
0
0
Rio de Janeiro
Query!
Country [45]
0
0
Brazil
Query!
State/province [45]
0
0
Salvador
Query!
Country [46]
0
0
Brazil
Query!
State/province [46]
0
0
Sao Paulo
Query!
Country [47]
0
0
Brazil
Query!
State/province [47]
0
0
Vitoria
Query!
Country [48]
0
0
Bulgaria
Query!
State/province [48]
0
0
Plovdiv
Query!
Country [49]
0
0
Bulgaria
Query!
State/province [49]
0
0
Sofia
Query!
Country [50]
0
0
Canada
Query!
State/province [50]
0
0
British Columbia
Query!
Country [51]
0
0
Canada
Query!
State/province [51]
0
0
Newfoundland and Labrador
Query!
Country [52]
0
0
Canada
Query!
State/province [52]
0
0
Quebec
Query!
Country [53]
0
0
China
Query!
State/province [53]
0
0
Anhui
Query!
Country [54]
0
0
China
Query!
State/province [54]
0
0
Beijing
Query!
Country [55]
0
0
China
Query!
State/province [55]
0
0
Chongqing
Query!
Country [56]
0
0
China
Query!
State/province [56]
0
0
Fujian
Query!
Country [57]
0
0
China
Query!
State/province [57]
0
0
Guangdong
Query!
Country [58]
0
0
China
Query!
State/province [58]
0
0
Heilongjiang
Query!
Country [59]
0
0
China
Query!
State/province [59]
0
0
Henan
Query!
Country [60]
0
0
China
Query!
State/province [60]
0
0
Hubei
Query!
Country [61]
0
0
China
Query!
State/province [61]
0
0
Hunan
Query!
Country [62]
0
0
China
Query!
State/province [62]
0
0
Jiangsu
Query!
Country [63]
0
0
China
Query!
State/province [63]
0
0
Jiangxi
Query!
Country [64]
0
0
China
Query!
State/province [64]
0
0
Jilin
Query!
Country [65]
0
0
China
Query!
State/province [65]
0
0
Liaoning
Query!
Country [66]
0
0
China
Query!
State/province [66]
0
0
Shandong
Query!
Country [67]
0
0
China
Query!
State/province [67]
0
0
Shanghai
Query!
Country [68]
0
0
China
Query!
State/province [68]
0
0
Shanxi
Query!
Country [69]
0
0
China
Query!
State/province [69]
0
0
Sichuan
Query!
Country [70]
0
0
China
Query!
State/province [70]
0
0
Zhejiang
Query!
Country [71]
0
0
Czechia
Query!
State/province [71]
0
0
Hradec Kralove
Query!
Country [72]
0
0
Czechia
Query!
State/province [72]
0
0
Olomouc
Query!
Country [73]
0
0
France
Query!
State/province [73]
0
0
Antony
Query!
Country [74]
0
0
France
Query!
State/province [74]
0
0
Le Mans
Query!
Country [75]
0
0
France
Query!
State/province [75]
0
0
Montpellier Cedex
Query!
Country [76]
0
0
France
Query!
State/province [76]
0
0
Nice
Query!
Country [77]
0
0
France
Query!
State/province [77]
0
0
Paris
Query!
Country [78]
0
0
France
Query!
State/province [78]
0
0
Strasbourg
Query!
Country [79]
0
0
France
Query!
State/province [79]
0
0
VandoeuvrelesNancy
Query!
Country [80]
0
0
Georgia
Query!
State/province [80]
0
0
Batumi
Query!
Country [81]
0
0
Georgia
Query!
State/province [81]
0
0
Kutaisi
Query!
Country [82]
0
0
Georgia
Query!
State/province [82]
0
0
Tbilisi
Query!
Country [83]
0
0
Greece
Query!
State/province [83]
0
0
Alexandroupolis
Query!
Country [84]
0
0
Greece
Query!
State/province [84]
0
0
Athens
Query!
Country [85]
0
0
Greece
Query!
State/province [85]
0
0
Patras
Query!
Country [86]
0
0
Ireland
Query!
State/province [86]
0
0
Dublin
Query!
Country [87]
0
0
Ireland
Query!
State/province [87]
0
0
Waterford
Query!
Country [88]
0
0
Israel
Query!
State/province [88]
0
0
Afula
Query!
Country [89]
0
0
Israel
Query!
State/province [89]
0
0
Ashdod
Query!
Country [90]
0
0
Israel
Query!
State/province [90]
0
0
Jerusalem
Query!
Country [91]
0
0
Israel
Query!
State/province [91]
0
0
Petach Tikva
Query!
Country [92]
0
0
Israel
Query!
State/province [92]
0
0
Ramat gan
Query!
Country [93]
0
0
Israel
Query!
State/province [93]
0
0
Tel Aviv
Query!
Country [94]
0
0
Italy
Query!
State/province [94]
0
0
Aviano
Query!
Country [95]
0
0
Italy
Query!
State/province [95]
0
0
Bologna
Query!
Country [96]
0
0
Italy
Query!
State/province [96]
0
0
Milano
Query!
Country [97]
0
0
Italy
Query!
State/province [97]
0
0
Novara
Query!
Country [98]
0
0
Italy
Query!
State/province [98]
0
0
Padova
Query!
Country [99]
0
0
Italy
Query!
State/province [99]
0
0
Pavia
Query!
Country [100]
0
0
Italy
Query!
State/province [100]
0
0
Reggio Emilia
Query!
Country [101]
0
0
Italy
Query!
State/province [101]
0
0
Udine
Query!
Country [102]
0
0
Italy
Query!
State/province [102]
0
0
Varese
Query!
Country [103]
0
0
Korea, Republic of
Query!
State/province [103]
0
0
Busan Gwang'yeogsi
Query!
Country [104]
0
0
Korea, Republic of
Query!
State/province [104]
0
0
Gyeonggi-do
Query!
Country [105]
0
0
Korea, Republic of
Query!
State/province [105]
0
0
Gyeongsangbukdo
Query!
Country [106]
0
0
Korea, Republic of
Query!
State/province [106]
0
0
Gyeongsangnamdo
Query!
Country [107]
0
0
Korea, Republic of
Query!
State/province [107]
0
0
Jeollanam-do
Query!
Country [108]
0
0
Korea, Republic of
Query!
State/province [108]
0
0
Seoul Teugbyeolsi
Query!
Country [109]
0
0
Poland
Query!
State/province [109]
0
0
Katowice
Query!
Country [110]
0
0
Poland
Query!
State/province [110]
0
0
Krakow
Query!
Country [111]
0
0
Poland
Query!
State/province [111]
0
0
Warsaw
Query!
Country [112]
0
0
Portugal
Query!
State/province [112]
0
0
Almada
Query!
Country [113]
0
0
Portugal
Query!
State/province [113]
0
0
Braga
Query!
Country [114]
0
0
Portugal
Query!
State/province [114]
0
0
Porto
Query!
Country [115]
0
0
Portugal
Query!
State/province [115]
0
0
VILA NOVA DE GAIA Porto
Query!
Country [116]
0
0
Puerto Rico
Query!
State/province [116]
0
0
Rio Piedras
Query!
Country [117]
0
0
Puerto Rico
Query!
State/province [117]
0
0
San Juan
Query!
Country [118]
0
0
Romania
Query!
State/province [118]
0
0
Bucharest
Query!
Country [119]
0
0
Romania
Query!
State/province [119]
0
0
ClujNapoca
Query!
Country [120]
0
0
Romania
Query!
State/province [120]
0
0
Iasi
Query!
Country [121]
0
0
Romania
Query!
State/province [121]
0
0
Oradea
Query!
Country [122]
0
0
Spain
Query!
State/province [122]
0
0
Badalona
Query!
Country [123]
0
0
Spain
Query!
State/province [123]
0
0
Burgos
Query!
Country [124]
0
0
Spain
Query!
State/province [124]
0
0
Cadiz
Query!
Country [125]
0
0
Spain
Query!
State/province [125]
0
0
Granada
Query!
Country [126]
0
0
Spain
Query!
State/province [126]
0
0
Hospitalet de LLobregat
Query!
Country [127]
0
0
Spain
Query!
State/province [127]
0
0
Leon
Query!
Country [128]
0
0
Spain
Query!
State/province [128]
0
0
Madrid
Query!
Country [129]
0
0
Spain
Query!
State/province [129]
0
0
Murcia
Query!
Country [130]
0
0
Spain
Query!
State/province [130]
0
0
Pamplona
Query!
Country [131]
0
0
Spain
Query!
State/province [131]
0
0
Pozuelo de Alarcon
Query!
Country [132]
0
0
Spain
Query!
State/province [132]
0
0
Salamanca
Query!
Country [133]
0
0
Spain
Query!
State/province [133]
0
0
Sevilla
Query!
Country [134]
0
0
Spain
Query!
State/province [134]
0
0
Terassa
Query!
Country [135]
0
0
Switzerland
Query!
State/province [135]
0
0
Fribourg
Query!
Country [136]
0
0
Switzerland
Query!
State/province [136]
0
0
La ChauxdeFonds
Query!
Country [137]
0
0
United Kingdom
Query!
State/province [137]
0
0
Glasgow
Query!
Country [138]
0
0
United Kingdom
Query!
State/province [138]
0
0
Greater Manchester
Query!
Country [139]
0
0
United Kingdom
Query!
State/province [139]
0
0
Huddersfield
Query!
Country [140]
0
0
United Kingdom
Query!
State/province [140]
0
0
Inverness
Query!
Country [141]
0
0
United Kingdom
Query!
State/province [141]
0
0
Leeds
Query!
Country [142]
0
0
United Kingdom
Query!
State/province [142]
0
0
London
Query!
Country [143]
0
0
United Kingdom
Query!
State/province [143]
0
0
Plymouth
Query!
Country [144]
0
0
United Kingdom
Query!
State/province [144]
0
0
Southampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
BeiGene
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of the study is to compare the efficacy of zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab (R\^2) in participants with relapsed/refractory (R/R) follicular lymphoma (FL), as measured by progression-free survival as determined by an independent review committee in accordance with the 2014 modification of the International Working Group on non-Hodgkin lymphoma (NHL) Criteria based on n positron emission tomography and computed tomography (PET/CT), and to compare the efficacy of zanubrutinib plus rituximab versus R\^2 in participants with R/R marginal zone lymphoma (MZL), as measured by progression free survival (PFS) assessed by IRC in accordance with CT-based Lugano 2014 Criteria.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05100862
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Study Director
Query!
Address
0
0
BeiGene
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Study Director BeiGene
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1-877-828-5568
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05100862