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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05952037
Registration number
NCT05952037
Ethics application status
Date submitted
11/07/2023
Date registered
19/07/2023
Titles & IDs
Public title
Study to Evaluate the Efficacy and Safety of Sonrotoclax in Participants With Waldenström's Macroglobulinemia
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Scientific title
An Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of the BCL2 Inhibitor Sonrotoclax (BGB-11417) as Monotherapy and in Combination With Zanubrutinib (BGB-3111) in Patients With Waldenström Macroglobulinemia
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Secondary ID [1]
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U1111-1291-4524
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Secondary ID [2]
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BGB-11417-203
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Waldenstrom Macroglobulinemia
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Waldenstrom's Macroglobulinemia Recurrent
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Waldenstrom's Macroglobulinemia Refractory
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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-11417
Treatment: Drugs - Zanubrutinib
Experimental: Cohort 1 - Participants with R/R disease to both Bruton tyrosine kinase (BTK) inhibitor and anti-CD20 antibody-based systemic therapy containing chemotherapy or proteasome inhibitor will receive sonrotoclax at a standard dose, given orally once daily.
Experimental: Cohort 2 - Participants with R/R disease to anti-CD20 antibody-based systemic therapy containing chemotherapy or proteasome inhibitor and were intolerant to BTK inhibitor will receive sonrotoclax at a standard dose, given orally once daily.
Experimental: Cohort 3 - Participants with R/R disease to a BTK inhibitor treatment and are unsuitable for chemoimmunotherapy will receive sonrotoclax at a standard dose, given orally once daily.
Experimental: Cohort 4 - Participants with previously untreated WM will receive sonrotoclax and zanubrutinib combination therapy with fixed duration.
Treatment: Drugs: BGB-11417
Administered orally as a tablet.
Treatment: Drugs: Zanubrutinib
Administered orally as a tablet.
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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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Cohort 1: Major Response Rate (MRR)
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Assessment method [1]
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MRR is defined as the proportion of participants achieving partial response (PR) or better, as assessed by the Independent Review Committee (IRC) per the 11th International Workshop on Waldenström Macroglobulinemia (IWWM-11) WM response criteria.
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Timepoint [1]
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Up to approximately 4 years
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Secondary outcome [1]
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Cohorts 2 and 3: MRR as assessed by the IRC
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Assessment method [1]
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MRR is defined as the proportion of participants achieving PR or better.
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Timepoint [1]
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Up to approximately 5 years
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Secondary outcome [2]
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All Cohorts: MRR as assessed by the Investigator
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Assessment method [2]
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MRR is defined as the proportion of participants achieving PR or better.
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Timepoint [2]
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Up to approximately 5 years
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Secondary outcome [3]
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Cohorts 1, 2, and 3: Duration of Major Response (DoMR) as assessed by the IRC
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Assessment method [3]
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DoMR is defined as the time from first determination of major response until first documentation of progression or death, whichever occurs first.
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Timepoint [3]
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Up to approximately 5 years
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Secondary outcome [4]
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All Cohorts: DoMR as assessed by the Investigator
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Assessment method [4]
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DoMR is defined as the time from first determination of major response until first documentation of progression or death, whichever occurs first.
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Timepoint [4]
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Up to approximately 5 years
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Secondary outcome [5]
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Cohorts 1, 2, and 3: Complete Response (CR) + Very Good Partial Response (VGPR) as assessed by the IRC
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Assessment method [5]
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CR + VGPR is defined as the percentage of participants who achieve CR or VGPR.
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Timepoint [5]
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Up to approximately 5 years
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Secondary outcome [6]
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All Cohorts: CR + VGPR as assessed by the Investigator
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Assessment method [6]
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CR + VGPR is defined as the percentage of participants who achieve CR or VGPR.
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Timepoint [6]
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Up to approximately 5 years
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Secondary outcome [7]
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Cohorts 1, 2, and 3: Overall Response Rate (ORR) as assessed by the IRC
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Assessment method [7]
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ORR is defined as the percentage of participants with minor response (MR) or better.
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Timepoint [7]
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Up to approximately 5 years
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Secondary outcome [8]
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All cohorts: ORR as assessed by the investigator
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Assessment method [8]
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ORR is defined as the percentage of participants with MR or better.
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Timepoint [8]
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Up to approximately 5 years
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Secondary outcome [9]
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Cohorts 1, 2, and 3: Duration of Response (DOR) as assessed by the IRC
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Assessment method [9]
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DOR is defined as the time from first determination of response until first documentation of progression or death, whichever occurs first.
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Timepoint [9]
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Up to approximately 5 years
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Secondary outcome [10]
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All Cohorts: DOR as assessed by the investigator
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Assessment method [10]
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DOR is defined as the time from first determination of response until first documentation of progression or death, whichever occurs first.
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Timepoint [10]
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Up to approximately 5 years
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Secondary outcome [11]
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Cohorts 1, 2, and 3: Progression-Free Survival (PFS)
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Assessment method [11]
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PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the IRC and by the investigator.
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Timepoint [11]
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Up to approximately 5 years
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Secondary outcome [12]
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Cohorts 1, 2, and 3: Time to major response as assessed by the IRC
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Assessment method [12]
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Time to major response is defined as the time from start of study treatment to the first documentation of major response.
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Timepoint [12]
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Up to approximately 5 years
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Secondary outcome [13]
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All Cohorts: Time to major response as assessed by the investigator
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Assessment method [13]
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Time to major response is defined as the time from start of study treatment to the first documentation of major response.
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Timepoint [13]
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Up to approximately 5 years
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Secondary outcome [14]
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Cohorts 1, 2, and 3: Overall Survival (OS)
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Assessment method [14]
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OS is defined as the time from first study drug administration to the date of death due to any cause.
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Timepoint [14]
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Up to approximately 5 years
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Secondary outcome [15]
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Time to next treatment in cohort 4
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Assessment method [15]
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Defined as the time from the start of treatment to the start of first subsequent therapy for WM.
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Timepoint [15]
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Up to approximately 5 years
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Secondary outcome [16]
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Number of participants reporting adverse events
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Assessment method [16]
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Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory abnormalities, physical examination results, and vital signs.
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Timepoint [16]
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Up to approximately 5 years
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Secondary outcome [17]
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Health-Related Quality of Life (HRQoL): NFLymSI-18
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Assessment method [17]
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HRQoL based on participant-reported outcomes using National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index - 18 Item (NFLymSI-18) Version 4. The questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and is divided into a total score.
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Timepoint [17]
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Up to approximately 5 years
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Eligibility
Key inclusion criteria
* Clinical and definitive histologic diagnosis of WM.
* Meeting = 1 criterion for treatment according to consensus panel criteria from the 2nd International Workshop on Waldenström's Macroglobulinemia (IWWM).
* For Cohorts 1-3, refractory or relapsed disease to the most recent therapy at study entry unless participants had intolerance to the most recent therapy. Refractory disease is defined as not attaining at least a major response, or progressing while on or within 6 months of completing therapy. Relapsed disease is defined as attaining at least a major response to therapy and meeting the criteria for disease progression beyond 6 months after completing therapy.
* For Cohort 4, patients must not have received prior therapy for WM.
* Adequate organ function.
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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
* Central nervous system (CNS) involvement by WM.
* Transformation to aggressive lymphoma, such as diffuse large B-cell lymphoma.
* History of other malignancies = 2 years before study entry.
* Uncontrolled active systemic infection or recent infection requiring parenteral antimicrobial therapy that was completed = 14 days before the first dose of the study drug.
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
Non-randomised 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 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
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
28/09/2023
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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
1/09/2028
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Actual
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Sample size
Target
105
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [2]
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Genesiscare North Shore - St Leonards
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Recruitment hospital [3]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [4]
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Flinders Medical Centre - Bedford PK
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Recruitment hospital [5]
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Monash Health - Clayton
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Recruitment hospital [6]
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St Vincents Hospital Melbourne - Fitzroy
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Recruitment hospital [7]
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Linear Clinical Research - Nedlands
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Recruitment postcode(s) [1]
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2139 - Concord
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment postcode(s) [3]
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4102 - Brisbane
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Recruitment postcode(s) [4]
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5042 - Bedford PK
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Recruitment postcode(s) [5]
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3168 - Clayton
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Recruitment postcode(s) [6]
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3065 - Fitzroy
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Recruitment postcode(s) [7]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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California
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Colorado
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District of Columbia
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Florida
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Iowa
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United States of America
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Maryland
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Massachusetts
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Mississippi
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New York
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North Carolina
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Ohio
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Canada
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British Columbia
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China
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Fujian
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Guangdong
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China
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Henan
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China
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Hubei
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China
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China
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Liaoning
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China
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Shandong
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China
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Shanghai
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China
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Shanxi
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China
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Tianjin
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China
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Zhejiang
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Amiens Cedex
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France
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Marseille
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France
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Paris
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Greece
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Athens
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Italy
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Bologna
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Italy
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Brescia
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Italy
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Milano
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Italy
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Pavia
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Terassa
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United Kingdom
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Bournemouth
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United Kingdom
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Glasgow
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United Kingdom
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Headington
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United Kingdom
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Inverness
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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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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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the safety and efficacy of the BCL2 inhibitor BGB-11417 (sonrotoclax) in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) and in combination with zanubrutinib in adult participants with previously untreated WM.
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Trial website
https://clinicaltrials.gov/study/NCT05952037
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Trial related presentations / publications
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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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Phone
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Fax
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Email
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Contact person for public queries
Name
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Study Director
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Address
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Country
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Phone
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1-877-828-5568
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Fax
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Email
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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?
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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
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05952037