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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
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
Secondary ID [1] 0 0
CTR20232545
Secondary ID [2] 0 0
BGB-3111-308
Universal Trial Number (UTN)
Trial acronym
MAHOGANY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed/Refractory Follicular Lymphoma 0 0
Marginal Zone 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 - 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival As Determined By A Blinded Independent Review Committee (BIRC)
Timepoint [1] 0 0
Approximately 78 months
Secondary outcome [1] 0 0
Progression-free Survival As Determined By Investigator Assessment
Timepoint [1] 0 0
Approximately 87 months
Secondary outcome [2] 0 0
Duration Of Response As Determined By BIRC And By Investigator Assessment
Timepoint [2] 0 0
Approximately 87 months
Secondary outcome [3] 0 0
Overall Response Rate As Determined By BIRC And By Investigator Assessment
Timepoint [3] 0 0
Approximately 87 months
Secondary outcome [4] 0 0
Complete Response Rate As Determined By BIRC And By Investigator Assessment
Timepoint [4] 0 0
Approximately 87 months
Secondary outcome [5] 0 0
Time To Response As Determined By BIRC And By Investigator Assessment
Timepoint [5] 0 0
Approximately 87 months
Secondary outcome [6] 0 0
Time to Next Ant-Lymphoma Treatment
Timepoint [6] 0 0
Approximately 87 months
Secondary outcome [7] 0 0
Overall Survival
Timepoint [7] 0 0
Approximately 87 months
Secondary outcome [8] 0 0
Health-related Quality Of Life (HRQoL) Using EORTC QLQ-C30)
Timepoint [8] 0 0
Approximately 87 months
Secondary outcome [9] 0 0
HRQoL Using European Quality of Life 5 Dimension 5 Level Questionnaire [EQ 5D 5L)
Timepoint [9] 0 0
Approximately 87 months
Secondary outcome [10] 0 0
HRQoL Using National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 [FLymSI 18)
Timepoint [10] 0 0
Approximately 87 months
Secondary outcome [11] 0 0
Number of Participants Experiencing Adverse Events (AEs)
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)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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
* Prior treatment with lenalidomide or drug from same class, if without response (partial or complete) or short remission duration (< 24 months)

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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2030
Actual
Sample size
Target
750
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Gosford Hospital - Gosford
Recruitment hospital [3] 0 0
St George Hospital - Kogarah
Recruitment hospital [4] 0 0
Orange Health Hospital - Orange
Recruitment hospital [5] 0 0
Port Macquarie Base Hospital - Port Macquarie
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Westmead Hospital - Westmead
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Sunshine Coast Hospital and Health Service - Birtinya
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Townsville University Hospital - Douglas
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Genesiscare North Adelaide - North Adelaide
Recruitment hospital [10] 0 0
Monash Health - Clayton
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St Vincents Hospital Melbourne - Fitzroy
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Austin Health - Heidelberg
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Cabrini Hospital Malvern - Malvern
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Epworth Freemasons - Melbourne
Recruitment hospital [15] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [16] 0 0
Royal Perth Hospital - Perth
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Perth Blood Institute - West Perth
Recruitment hospital [18] 0 0
La Trobe Regional Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2800 - Orange
Recruitment postcode(s) [5] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [6] 0 0
2145 - Westmead
Recruitment postcode(s) [7] 0 0
4575 - Birtinya
Recruitment postcode(s) [8] 0 0
4814 - Douglas
Recruitment postcode(s) [9] 0 0
5006 - North Adelaide
Recruitment postcode(s) [10] 0 0
3168 - Clayton
Recruitment postcode(s) [11] 0 0
3065 - Fitzroy
Recruitment postcode(s) [12] 0 0
3084 - Heidelberg
Recruitment postcode(s) [13] 0 0
3144 - Malvern
Recruitment postcode(s) [14] 0 0
3002 - Melbourne
Recruitment postcode(s) [15] 0 0
3004 - Melbourne
Recruitment postcode(s) [16] 0 0
6000 - Perth
Recruitment postcode(s) [17] 0 0
6005 - West Perth
Recruitment postcode(s) [18] 0 0
3844 - Melbourne
Recruitment outside Australia
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Caba
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Cordoba
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Innsbruck
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St Poelten
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Vienna
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VandoeuvrelesNancy
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Georgia
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Batumi
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Kutaisi
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Tbilisi
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Germany
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Reggio Emilia
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Terassa
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Switzerland
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Basel
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Switzerland
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Fribourg
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Switzerland
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La ChauxdeFonds
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Switzerland
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Zurich
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Turkey
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Ankara
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Turkey
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Atakum Samsun
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Turkey
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Gazi University Medical School
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Turkey
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Istanbul
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Izmir
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Kocaeli
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Southampton

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
Study Director BeiGene
Address 0 0
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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?
IPD available at link: https://www.beigenemedical.com/medical-information-request


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