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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04002297
Registration number
NCT04002297
Ethics application status
Date submitted
27/06/2019
Date registered
28/06/2019
Date last updated
25/03/2025
Titles & IDs
Public title
A Study to Investigate the Efficacy of Zanubrutinib Plus Rituximab Compared With Bendamustine Plus Rituximab in Adults With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation
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Scientific title
A Phase 3 Randomized, Open-Label, Multicenter Study Comparing Zanubrutinib (BGB-3111) Plus Rituximab Versus Bendamustine Plus Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation
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Secondary ID [1]
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2019-000413-36
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Secondary ID [2]
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BGB-3111-306
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Universal Trial Number (UTN)
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Trial acronym
MANGROVE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mantle Cell Lymphoma; Non-Hodgkin Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - zanubrutinib
Treatment: Drugs - bendamustine
Treatment: Drugs - rituximab
Experimental: Arm A: zanubrutinib plus rituximab - Participants will receive zanubrutinib plus rituximab, followed by zanubrutinib monotherapy until Independent Review Committee (IRC)-confirmed disease progression.
Active comparator: Arm B: bendamustine plus rituximab - Participants will receive bendamustine plus rituximab, followed by observation.
Treatment: Drugs: zanubrutinib
Administered as two 80 mg capsules by mouth twice a day
Treatment: Drugs: bendamustine
Administered intravenously at a dose of 90 mg/m2/day on Days 1 and 2 of Cycles 1 to 6
Treatment: Drugs: rituximab
Administered intravenously at a dose of 375 mg/m2 on Day 1 of Cycles 1 to 6
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free survival (PFS) determined by independent central review
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Assessment method [1]
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PFS is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurs first.
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Timepoint [1]
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Up to approximately 7 years
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Secondary outcome [1]
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PFS by investigator assessment
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Assessment method [1]
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PFS is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurs first.
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Timepoint [1]
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Up to approximately 7 years
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Secondary outcome [2]
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Overall response rate (ORR)
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Assessment method [2]
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ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR), determined by independent central review and by investigator assessment.
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Timepoint [2]
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Up to approximately 7 years
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Secondary outcome [3]
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Duration of response (DOR)
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Assessment method [3]
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DOR, as determined by independent central review and by investigator assessment, and defined as the time from the date that response criteria are first met to the date that disease progression is objectively documented or death, whichever occurs first.
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Timepoint [3]
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Up to approximately 7 years
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Secondary outcome [4]
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Overall survival (OS)
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Assessment method [4]
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OS is defined as the time from randomization to the date of death due to any reason.
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Timepoint [4]
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Up to approximately 7 years
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Secondary outcome [5]
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Time to Response (TTR)
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Assessment method [5]
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TTR, as determined by independent central review and by investigator assessment, and defined as the time from randomization to the first documentation of response.
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Timepoint [5]
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Up to approximately 7 years
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Secondary outcome [6]
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Rate of complete response (CR) or complete metabolic response
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Assessment method [6]
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Rate of CR or complete metabolic response is defined as the percentage of participants who achieve a CR or complete metabolic response, determined by independent central review and by investigator assessment.
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Timepoint [6]
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Up to approximately 7 years
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Secondary outcome [7]
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Participant-reported outcomes (PROs) as assessed by the European Quality of Life 5-Dimension 5 Level Questionnaire (EQ-5D-5L)
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Assessment method [7]
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EuroQoL-Five Dimensions, Five Levels (EQ-5D-5L) is a generic, self-reported measure of utility that consists of a five-item descriptive system and a visual analogue scale (EQ VAS). The descriptive system involves five health dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Participants may choose from the following response levels: no problems=1; slight problems=2; moderate problems=3; severe problems=4; and unable to/extreme problems=5. Higher values indicate worst health.
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Timepoint [7]
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Up to approximately 7 years
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Secondary outcome [8]
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PROs as assessed by the European Organization for Research on Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
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Assessment method [8]
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The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 =Not at all (best) to 4 =Very Much (worst) and 2 questions answered on a 7-point scale where 1 =Very poor (worst) to 7 =Excellent (best).
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Timepoint [8]
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Up to approximately 7 years
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Secondary outcome [9]
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Number of participants with adverse events and serious adverse events
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Assessment method [9]
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Number of participants with adverse events and serious adverse events, including laboratory values, vital signs, and physical examination findings.
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Timepoint [9]
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Up to approximately 7 years
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Eligibility
Key inclusion criteria
Key
1. =70 years of age at the time of informed consent, OR =60 and <70 years of age with comorbidities precluding autologous stem cell transplantation
2. Histologically confirmed diagnosis of MCL
3. No prior systemic treatments for MCL
4. Measurable disease by CT/MRI
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
6. Adequate marrow and organ function
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Minimum age
60
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Known central nervous system involvement by lymphoma
2. Participants for whom the goal of therapy is tumor debulking prior to stem cell transplant
3. Clinically significant cardiovascular disease
4. History of severe bleeding disorder
5. Unable to swallow capsules or disease significantly affecting gastrointestinal function
6. Active fungal, bacterial and/or viral infection requiring systemic therapy
7. Requires ongoing treatment with a strong CYP3A inhibitor or inducer
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/08/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2027
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Actual
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Sample size
Target
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Accrual to date
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Final
510
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Canberra Hospital - Garran
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Concord Repatriation General Hospital - Concord
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The Tweed Valley Hospital - Cudgen
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Saint Vincents Hospital Sydney - Darlinghurst
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Gosford Hospital - Gosford
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Calvary Mater Newcastle - Waratah
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Sunshine Coast Hospital and Health Service - Birtinya
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Icon Cancer Foundation - South Brisbane
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Flinders Medical Centre - Bedford PK
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Royal Hobart Hospital - Hobart
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Monash Health - Clayton
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St Vincents Hospital Melbourne - Fitzroy
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Peninsula Private Hospital - Frankston
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Barwon Health the Geelong Hospital - Geelong
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Royal Perth Hospital - Perth
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2605 - Garran
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2139 - Concord
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2487 - Cudgen
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2010 - Darlinghurst
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2250 - Gosford
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2298 - Waratah
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4575 - Birtinya
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4101 - South Brisbane
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5042 - Bedford PK
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7000 - Hobart
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3168 - Clayton
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3065 - Fitzroy
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3199 - Frankston
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Recruitment postcode(s) [14]
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3220 - Geelong
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Recruitment postcode(s) [15]
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6000 - Perth
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Recruitment outside Australia
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Poland
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Warszawa
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Bucuresti
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Romania
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Iasi
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Russian Federation
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Moskva
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Russian Federation
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Russian Federation
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Ukraine
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Lviv
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Dudley
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United Kingdom
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
BeiGene
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Summary
Brief summary
This is a randomized study to compare the efficacy and safety of zanubrutinib plus rituximab versus bendamustine plus rituximab in previously untreated participants with mantle cell lymphoma (MCL) who are not eligible for stem cell transplantation.
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Trial website
https://clinicaltrials.gov/study/NCT04002297
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Trial related presentations / publications
Dreyling M, Tam CS, Wang M, Smith SD, Ladetto M, Huang H, Novotny W, Co M, Romano A, Holmgren E, Huang J, Gouill SL. A Phase III study of zanubrutinib plus rituximab versus bendamustine plus rituximab in transplant-ineligible, untreated mantle cell lymphoma. Future Oncol. 2021 Jan;17(3):255-262. doi: 10.2217/fon-2020-0794. Epub 2020 Sep 28.
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Public notes
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Contacts
Principal investigator
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Study Director
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BeiGene
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Contact person for public queries
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BeiGene
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1-877-828-5568
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
See plan description
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Available to whom?
See plan description
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://beigene.com/science/clinical-trials/
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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/NCT04002297
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