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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05828589
Registration number
NCT05828589
Ethics application status
Date submitted
12/04/2023
Date registered
25/04/2023
Titles & IDs
Public title
A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies
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Scientific title
A Phase 1/1b Open-Label Dose-Escalation Study of Bcl-2 Inhibitor BGB-21447 in Patients With Mature B-Cell Malignancies
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Secondary ID [1]
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CT-2023-CTN-05421-1
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Secondary ID [2]
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BGB-21447-101
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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:
Relapsed Non-Hodgkin Lymphoma
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Refractory Non-Hodgkin Lymphoma
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Relapsed Chronic Lymphocytic Leukemia
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Refractory Chronic Lymphocytic Leukemia
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0
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Relapsed Follicular Lymphoma
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0
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Relapsed Marginal Zone Lymphoma
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Relapse Diffuse Large B Cell Lymphoma
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0
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Relapsed Small Lymphocytic Lymphoma
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0
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Refractory Follicular Lymphoma
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Refractory Marginal Zone Lymphoma
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Refractory Small Lymphocytic Lymphoma
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Richter Transformation
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Refractory Diffuse Large B-cell Lymphoma
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Transformed 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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Cancer
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0
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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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-21447
Experimental: Part 1 (Cohort A1): Dose escalation in patients with B-cell non-Hodgkin lymphoma (NHL) - Participants with R/R B-cell NHL (including diffuse large B-cell lymphoma \[DLBCL\], follicular lymphoma \[FL\], marginal zone lymphoma \[MZL\], transformed B-cell NHL (B-NHL), and Richter's transformation to DLBCL) will receive BGB-21447 once a day.
Experimental: Part 1 (Cohort B): Dose escalation in R/R CLL/SLL participants with low tumor burden - Participants with relapsed/refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) will receive BGB-21447 once a day.
Experimental: Part 2 (Cohort A2): BGB-21447 Monotherapy Dose Expansion - Participants will receive BGB-21447 with up to two dose levels from Cohort A1 for further evaluation of safety and efficacy.
Treatment: Drugs: BGB-21447
BGB-21447 will be administered orally
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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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Part 1: Number of participants with dose limiting toxicities (DLTs)
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Assessment method [1]
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Number of participants with dose limiting toxicities, defined as \[see text in SAP or protocol for specific definition\]
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Timepoint [1]
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Up to approximately four years
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Primary outcome [2]
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Number of participants with adverse events (AEs)
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Assessment method [2]
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Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) assessed and graded based upon the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0).
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Timepoint [2]
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Up to approximately four years
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Primary outcome [3]
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Number of participants with Tumor Lysis Syndrome (TLS)
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Assessment method [3]
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TLS will be determined via laboratory values and assessed by the investigator.
In laboratory tumor lysis syndrome, 2 or more metabolic abnormalities must be present during the 24-hour period within 3 days before the start of study drug treatment or up to 7 days afterward. Clinical tumor lysis syndrome requires the presence of laboratory tumor lysis syndrome plus an increased creatinine level, seizures, cardiac dysrhythmia, or death.
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Timepoint [3]
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Up to approximately four years
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Secondary outcome [1]
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Maximum observed plasma concentration (Cmax) of BGB-21447
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Assessment method [1]
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Timepoint [1]
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Up to approximately four years
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Secondary outcome [2]
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Pre-dose trough concentration (Ctrough) of BGB-21447
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Assessment method [2]
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Timepoint [2]
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Up to approximately four years
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Secondary outcome [3]
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Area under the curve from time 0 to the last sampling time point within the dose interval (AUClast) of BGB-21447
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Assessment method [3]
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Timepoint [3]
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Up to approximately four years
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Secondary outcome [4]
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Area under the curve from time 0 extrapolated to infinity (AUCinf) of BGB-21447
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Assessment method [4]
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Timepoint [4]
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Up to approximately four years
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Secondary outcome [5]
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Time to reach maximum observed plasma concentration (Tmax) of BGB-21447
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Assessment method [5]
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Timepoint [5]
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Up to approximately four years
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Secondary outcome [6]
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Apparent terminal elimination half life (t1/2) of BGB-21447
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Assessment method [6]
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Timepoint [6]
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Up to approximately four years
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Secondary outcome [7]
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Apparent oral clearance (CL/F) of BGB-21447
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Assessment method [7]
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Timepoint [7]
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Up to approximately four years
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Secondary outcome [8]
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Apparent volume of distribution (Vz/F) of BGB-21447
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Assessment method [8]
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Timepoint [8]
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Up to approximately four years
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Secondary outcome [9]
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Steady state maximum observed plasma concentration (Cmax) of BGB-21447
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Assessment method [9]
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Timepoint [9]
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Up to approximately four years
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Secondary outcome [10]
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Steady state pre-dose trough concentration (Ctrough) of BGB-21447
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Assessment method [10]
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Timepoint [10]
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Up to approximately four years
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Secondary outcome [11]
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Steady state area under the curve from time 0 to the last sampling time point within the dose interval (AUClast) of *drug name*
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Assessment method [11]
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Timepoint [11]
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Up to approximately four years
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Secondary outcome [12]
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Steady state area under the curve from time 0 extrapolated to infinity (AUCinf) of BGB-21447
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Assessment method [12]
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Timepoint [12]
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Up to approximately four years
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Secondary outcome [13]
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Steady state time to reach maximum observed plasma concentration (Tmax) of BGB-21447
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Assessment method [13]
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Timepoint [13]
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Up to approximately four years
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Secondary outcome [14]
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Steady state apparent terminal elimination half life (t1/2) of BGB-21447
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Assessment method [14]
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Timepoint [14]
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Up to approximately four years
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Secondary outcome [15]
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Steady state apparent oral clearance (CL/F) of BGB-21447
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Assessment method [15]
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Timepoint [15]
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Up to approximately four years
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Secondary outcome [16]
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Steady state apparent volume of distribution (Vz/F) of BGB-21447
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Assessment method [16]
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Timepoint [16]
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Up to approximately four years
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Secondary outcome [17]
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Overall response rate (ORR)
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Assessment method [17]
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defined as the percentage of patients who achieve partial response or better for diffuse large B-cell lymphoma, marginal zone lymphoma, follicular lymphoma, transformed B-NHL, and Richter's transformation to DLBCL as per the Lugano Classification for non-Hodgkin lymphoma
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Timepoint [17]
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Up to approximately four years
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Secondary outcome [18]
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Duration of Response (DOR)
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Assessment method [18]
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defined as the time from the first response documentation to the date that progression is documented after treatment initiation or death due to any cause, whichever occurs first.
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Timepoint [18]
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Up to approximately four years
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Secondary outcome [19]
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Time to response (TTR)
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Assessment method [19]
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defined as the time from treatment initiation to the first documentation of response.
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Timepoint [19]
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Up to approximately four years
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Secondary outcome [20]
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Progression-free survival (PFS)
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Assessment method [20]
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defined as the time from treatment initiation to the first documented disease progression or death due to any cause, whichever occurs first.
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Timepoint [20]
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Up to approximately four years
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Eligibility
Key inclusion criteria
Inclusion Criteria
1. Confirmed diagnosis (per World Health Organization [WHO] guidelines, unless otherwise noted) of one of the following:
Cohort A1 and Cohort A2:
1. R/R DLBCL
2. R/R FL
3. R/R MZL
4. Transformed B-cell NHL
5. Richter's transformation to DLBCL
2. Measurable disease by computed tomography/magnetic resonance imaging.
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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
1. Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score = 6 prostate cancer
2. Known central nervous system involvement by lymphoma/leukemia
3. Prior autologous stem cell transplant < 3 months before the first dose of study drug. Or prior chimeric antigen receptor T-cell (CAR-T) therapy < 3 months before the first dose of study drug
4. Prior allogeneic stem cell transplant.
5. Major surgery < 4 weeks before the first dose of study treatment
NOTE: Other 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
Other
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Other design features
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Phase
Phase 1
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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
20/06/2023
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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
1/10/2026
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Actual
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Sample size
Target
85
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
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Recruitment hospital [1]
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Blacktown Cancer and Haematology Centre - Blacktown
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Recruitment hospital [2]
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Pindara Private Hospital - Benowa
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Recruitment hospital [3]
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Linear Clinical Research - Nedlands
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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4217 - Benowa
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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China
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State/province [1]
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Beijing
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Country [2]
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China
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State/province [2]
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Fujian
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Country [3]
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China
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State/province [3]
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Henan
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Country [4]
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China
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State/province [4]
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Hubei
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Country [5]
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China
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State/province [5]
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Jiangsu
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Country [6]
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China
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State/province [6]
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Jiangxi
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Country [7]
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China
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State/province [7]
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Liaoning
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Country [8]
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China
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State/province [8]
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Shandong
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Country [9]
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China
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State/province [9]
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Shanghai
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Country [10]
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China
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State/province [10]
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Tianjin
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Country [11]
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China
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State/province [11]
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Zhejiang
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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 is testing the safety and tolerability of BGB-21447 monotherapy in participants with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study aims to determine the maximum tolerated dose (MTD), maximum adminstered dose (MAD), recommended Phase 2 dose (RP2D), and pharmacokinetic profile of the drug. Additionally, preliminary antitumor activity will be characterized. The study is divided into 2 main parts: Part 1 "Monotherapy Dose Finding" and Part 2 "Monotherapy Dose Expansion."
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Trial website
https://clinicaltrials.gov/study/NCT05828589
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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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Address
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Country
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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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BeiGene
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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/NCT05828589