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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03053440
Registration number
NCT03053440
Ethics application status
Date submitted
7/02/2017
Date registered
15/02/2017
Titles & IDs
Public title
A Study Comparing BGB-3111 and Ibrutinib in Participants With Waldenström's Macroglobulinemia (WM)
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Scientific title
A Phase 3, Randomized, Open-Label, Multicenter Study Comparing the Efficacy and Safety of the Bruton's Tyrosine Kinase (BTK) Inhibitors BGB-3111 and Ibrutinib in Subjects With Waldenström's Macroglobulinemia (WM)
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Secondary ID [1]
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2016-002980-33
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Secondary ID [2]
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BGB-3111-302
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Universal Trial Number (UTN)
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Trial acronym
ASPEN
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Waldenström's Macroglobulinemia
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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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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BGB-3111
Treatment: Drugs - Ibrutinib
Experimental: Arm A : Ibrutinib - Participants with the MYD88 mutation received Ibrutinib
Active comparator: Arm B: Zanubrutinib - Participants with the MYD88 mutation received zanubrutinib
Treatment: Drugs: BGB-3111
160 mg PO BID until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
Treatment: Drugs: Ibrutinib
420 mg PO QD until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
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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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Percentage of Participants Achieving Either a Complete Response (CR) or Very Good Partial Response (VGPR) Using an Adaptation of the Response Criteria Updated at the Sixth International Workshop on WM as Assessed by an Independent Review Committee (IRC)
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Assessment method [1]
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Percentage of participants with CR, defined as normal serum immunoglobulin M (IgM) levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at baseline, or VGPR, defined as =90% reduction in serum IgM level from baseline or normal serum IgM values.
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Timepoint [1]
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Up to approximately 2 years and 7 months
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Secondary outcome [1]
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Percentage of Participants Achieving Major Response Rate (MRR) as Assessed by IRC
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Assessment method [1]
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MRR defined as the percentage of participants achieving a best response of response of CR, defined as normal serum IgM levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at baseline, VGPR, defined as =90% reduction in serum IgM level from baseline or normal serum IgM values or partial response (PR) defined as =50% reduction of serum IgM from baseline.
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Timepoint [1]
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Up to approximately 2 years and 7 months
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Secondary outcome [2]
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Duration of Response (DOR) as Assessed by IRC
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Assessment method [2]
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DOR defined as the time from first determination of response (CR, VGPR or PR) until first documentation of progression or death, whichever comes first. CR is defined as normal serum IgM levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at baseline, VGPR, is defined as =90% reduction in serum IgM level from baseline or normal serum IgM values or partial response (PR) is defined as =50% reduction of serum IgM from baseline.
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Timepoint [2]
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Up to approximately 2 years and 7 months
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Secondary outcome [3]
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DOR as Assessed by IRC: Event -Free Rate
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Assessment method [3]
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Estimated percentage of participants who were event-free based on Kaplan-Meier method.
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Timepoint [3]
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12 and 18 months from the date of randomization (up to approximately 2 years and 7 months)
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Secondary outcome [4]
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Percentage of Participants Achieving Either CR or VGPR in as Assessed by the Investigator
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Assessment method [4]
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Percentage of participants with CR, defined as normal serum IgM levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at Baseline, or VGPR, defined as =90% reduction in serum IgM level from baseline or normal serum IgM values.
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Timepoint [4]
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Up to approximately 5 years and 5 months
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Secondary outcome [5]
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DOR as Assessed by the Investigator
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Assessment method [5]
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DOR is defined as the time from first determination of response (CR, VGPR or PR) until first documentation of progression or death, whichever comes first
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Timepoint [5]
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Up to approximately 5 years and 5 months
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Secondary outcome [6]
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DOR as Assessed by the Investigator: Event-Free Rate
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Assessment method [6]
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Estimated percentage of participants who were event-free based on Kaplan-Meier method.
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Timepoint [6]
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24,36 and 48 months from the date of randomization (up to approximately 5 years and 5 months)
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Secondary outcome [7]
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Progression Free Survival (PFS) as Assessed by the IRC
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Assessment method [7]
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PFS as assessed by the IRC, defined as time from randomization to the first documentation of progression (per modified International Workshop on Waldenström macroglobulinemia \[IWWM criteria\]) or death, whichever occurs first
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Timepoint [7]
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Up to approximately 2 years and 7 months
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Secondary outcome [8]
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PFS as Assessed by IRC: Event-Free Rate
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Assessment method [8]
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Estimated percentage of participants who were event-free based on Kaplan-Meier method
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Timepoint [8]
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12 and 18 months from the date of randomization (up to approximately 2 years and 7 months)
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Secondary outcome [9]
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PFS as Assessed by the Investigator
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Assessment method [9]
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PFS as assessed by the Investigator, defined as time from randomization to the first documentation of progression (per modified IWWM criteria) or death, whichever occurs first.
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Timepoint [9]
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Up to approximately 5 years and 5 months
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Secondary outcome [10]
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PFS as Assessed by the Investigator: Event-Free Rate
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Assessment method [10]
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Percentage of participants who were event-free based on Kaplan-Meier method.
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Timepoint [10]
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24,36 and 48 months from the date of randomization (up to approximately 5 years and 5 months)
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Secondary outcome [11]
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Percentage of Participants With Resolution of All Treatment-precipitating Symptoms
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Assessment method [11]
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Timepoint [11]
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Up to approximately 5 years and 5 months
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Secondary outcome [12]
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Percentage of Participants With an Anti-Lymphoma Effect
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Assessment method [12]
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Anti-Lymphoma Effect is defined as any reduction in bone marrow involvement by lymphoplasmacytoid lymphocytes and/or size of lymphadenopathy and/or splenomegaly by CT scan, at any time during the course of study treatment.
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Timepoint [12]
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Up to approximately 5 years and 5 months
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Secondary outcome [13]
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Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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Assessment method [13]
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Timepoint [13]
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Up to approximately 5 years and 5 months
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Eligibility
Key inclusion criteria
Key
* Clinical and definitive histologic diagnosis of WM
* Measurable disease, requiring treatment
* Participants with no prior therapy for WM, must be considered inappropriate candidates for treatment with a standard chemoimmunotherapy regimen
* Age = 18 years old
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Adequate bone marrow function
* Adequate renal and hepatic function
* Electrocardiogram/multigated acquisition scan (ECHO/MUGA) demonstrating left ventricular ejection fraction (LVEF)= the lower limit of institutional normal
* Participants may be enrolled who relapse after autologous stem cell transplant if they are at least 3 months after transplant, and after allogeneic transplant if they are at least 6 months post-transplant.
* Females of childbearing potential must agree to use highly effective forms of birth control throughout the course of the study and at least up to 90 days after last dose of study drug. Males must have undergone sterilization- vasectomy, or utilize a barrier method
* Life expectancy of > 4 months
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Minimum age
18
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
* Prior exposure to a BTK inhibitor
* Evidence of disease transformation at the time of study entry
* Corticosteroids given with antineoplastic intent within 7 days, or chemotherapy given with antineoplastic intent, targeted therapy, or radiation therapy within 3 weeks, or antibody-based therapy within 4 weeks of the start of study drug
* Major surgery within 4 weeks of study treatment
* Toxicity of = Grade 2 from prior anticancer therapy
* History of other active malignancies within 2 years of study entry, with exception of (1) adequately treated in-situ carcinoma of cervix; (2) localized basal cell or squamous cell carcinoma of skin; (3) previous malignancy confined and treated locally with curative intent
* Currently active, clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, any Class 3 or 4 cardiac disease within 6 months of screening
* QTcF prolongation (defined as a QTcF > 480 msec)
* Active, clinically significant Electrocardiogram (ECG) abnormalities
* Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction
* Uncontrolled active systemic infection or recent infection requiring parenteral anti-microbial therapy
* Known human immunodeficiency virus (HIV), or active hepatitis B or hepatitis C
* Pregnant or lactating women
* Any life-threatening illness, medical condition, organ system dysfunction, need for profound anticoagulation, or bleeding disorder, which, in the investigator's opinion, could compromise the subject's safety
* Any medications which are strong or moderate cytochrome P450, family 3, subfamily A (CYP3A) inhibitors or strong CYP3A inducers
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
Completed
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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
25/01/2017
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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
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Actual
21/06/2022
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Sample size
Target
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Accrual to date
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Final
201
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Woden Dermatology - Phillip
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St George Hospital - Kogarah
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Royal North Shore Hospital - St Leonards
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [5]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [6]
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Peninsula Health - Frankston
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Recruitment hospital [7]
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Barwon Health, University Hospital Geelong - Geelong
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Recruitment hospital [8]
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St. Vincent's Hospital - Melbourne
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Recruitment hospital [9]
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Monash Medical Centre - Melbourne
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Recruitment hospital [10]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [11]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
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2606 - Phillip
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Recruitment postcode(s) [2]
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2217 - Kogarah
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Recruitment postcode(s) [3]
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2065 - St Leonards
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Recruitment postcode(s) [4]
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4102 - Woolloongabba
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Recruitment postcode(s) [5]
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- Bedford Park
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Recruitment postcode(s) [6]
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3199 - Frankston
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Recruitment postcode(s) [7]
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3220 - Geelong
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Recruitment postcode(s) [8]
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3065 - Melbourne
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Recruitment postcode(s) [9]
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- Melbourne
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Recruitment postcode(s) [10]
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- Nedlands
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Recruitment outside Australia
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United States of America
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Arizona
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Tennessee
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Brugge
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Hradec Králové
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Navarro
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Plymouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
BeiGene
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study evaluated the safety, efficacy and clinical benefit of BGB-3111 (zanubrutinib) vs ibrutinib in participants with MYD88 Mutation Waldenström's Macroglobulinemia.
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Trial website
https://clinicaltrials.gov/study/NCT03053440
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Trial related presentations / publications
Tam CS, LeBlond V, Novotny W, Owen RG, Tedeschi A, Atwal S, Cohen A, Huang J, Buske C. A head-to-head Phase III study comparing zanubrutinib versus ibrutinib in patients with Waldenstrom macroglobulinemia. Future Oncol. 2018 Sep;14(22):2229-2237. doi: 10.2217/fon-2018-0163. Epub 2018 Jun 5.
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Public notes
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Contacts
Principal investigator
Name
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Study Director
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Address
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BeiGene
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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?
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/40/NCT03053440/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/40/NCT03053440/SAP_001.pdf
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Tam CS, LeBlond V, Novotny W, Owen RG, Tedeschi A,...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT03053440