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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
Scientific title
A Phase 1/1b Open-Label Dose-Escalation Study of Bcl-2 Inhibitor BGB-21447 in Patients With Mature B-Cell Malignancies
Secondary ID [1] 0 0
CT-2023-CTN-05421-1
Secondary ID [2] 0 0
BGB-21447-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed Non-Hodgkin Lymphoma 0 0
Refractory Non-Hodgkin Lymphoma 0 0
Relapsed Chronic Lymphocytic Leukemia 0 0
Refractory Chronic Lymphocytic Leukemia 0 0
Relapsed Follicular Lymphoma 0 0
Relapsed Marginal Zone Lymphoma 0 0
Relapse Diffuse Large B Cell Lymphoma 0 0
Relapsed Small Lymphocytic Lymphoma 0 0
Refractory Follicular Lymphoma 0 0
Refractory Marginal Zone Lymphoma 0 0
Refractory Small Lymphocytic Lymphoma 0 0
Richter Transformation 0 0
Refractory Diffuse Large B-cell Lymphoma 0 0
Transformed Non-Hodgkin Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Number of participants with dose limiting toxicities (DLTs)
Assessment method [1] 0 0
Number of participants with dose limiting toxicities, as defined in the study protocol.
Timepoint [1] 0 0
Up to approximately 1 month
Primary outcome [2] 0 0
Number of participants with adverse events (AEs)
Assessment method [2] 0 0
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).
Timepoint [2] 0 0
From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurs first; up to approximately 12 months
Primary outcome [3] 0 0
Number of participants with Tumor Lysis Syndrome (TLS)
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurs first; up to approximately 12 months
Secondary outcome [1] 0 0
Maximum observed plasma concentration (Cmax) After a Single Dose of BGB-21447
Assessment method [1] 0 0
Timepoint [1] 0 0
Up to approximately 8 weeks
Secondary outcome [2] 0 0
Area under the curve from time 0 to the last sampling time point within the dose interval (AUC0-t) After a Single Dose of BGB-21447
Assessment method [2] 0 0
Timepoint [2] 0 0
Up to approximately 8 weeks
Secondary outcome [3] 0 0
Area under the curve from time 0 extrapolated to infinity time (AUCinf) After a Single Dose of BGB-21447
Assessment method [3] 0 0
Timepoint [3] 0 0
Up to approximately 8 weeks
Secondary outcome [4] 0 0
Time to reach maximum observed plasma concentration (Tmax) After a Single Dose of BGB-21447
Assessment method [4] 0 0
Timepoint [4] 0 0
Up to approximately 8 weeks
Secondary outcome [5] 0 0
Apparent terminal elimination half-life (t1/2) After a Single Dose of BGB-21447
Assessment method [5] 0 0
Timepoint [5] 0 0
Up to approximately 8 weeks
Secondary outcome [6] 0 0
Apparent oral clearance (CL/F) After a Single Dose of BGB-21447
Assessment method [6] 0 0
Timepoint [6] 0 0
Up to approximately 8 weeks
Secondary outcome [7] 0 0
Apparent volume of distribution (Vz/F) After a Single Dose of BGB-21447
Assessment method [7] 0 0
Timepoint [7] 0 0
Up to approximately 8 weeks
Secondary outcome [8] 0 0
Steady state maximum observed plasma concentration (Cmax,ss) of BGB-21447
Assessment method [8] 0 0
Timepoint [8] 0 0
Up to approximately 8 weeks
Secondary outcome [9] 0 0
Steady state pre-dose trough concentration (Ctrough,ss) of BGB-21447
Assessment method [9] 0 0
Timepoint [9] 0 0
Up to approximately 8 weeks
Secondary outcome [10] 0 0
Steady state area under the curve from time 0 to the quantifiable concentration (AUClast,ss) of BGB-21447
Assessment method [10] 0 0
Timepoint [10] 0 0
Up to approximately 8 weeks
Secondary outcome [11] 0 0
Steady state time to reach maximum observed plasma concentration (Tmax,ss) of BGB-21447
Assessment method [11] 0 0
Timepoint [11] 0 0
Up to approximately 8 weeks
Secondary outcome [12] 0 0
Overall response rate (ORR)
Assessment method [12] 0 0
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.
Timepoint [12] 0 0
Up to approximately 24 months
Secondary outcome [13] 0 0
Duration of Response (DOR)
Assessment method [13] 0 0
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.
Timepoint [13] 0 0
Up to approximately 24 months
Secondary outcome [14] 0 0
Time to response (TTR)
Assessment method [14] 0 0
Defined as the time from treatment initiation to the first documentation of response.
Timepoint [14] 0 0
Up to approximately 24 months
Secondary outcome [15] 0 0
Progression-free survival (PFS)
Assessment method [15] 0 0
Defined as the time from treatment initiation to the first documented disease progression or death due to any cause, whichever occurs first.
Timepoint [15] 0 0
Up to approximately 24 months

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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 protocol-defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2026
Actual
Sample size
Target
85
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Blacktown Cancer and Haematology Centre - Blacktown
Recruitment hospital [2] 0 0
Pindara Private Hospital - Benowa
Recruitment hospital [3] 0 0
Monash Health - Clayton
Recruitment hospital [4] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
4217 - Benowa
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Iowa
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
United States of America
State/province [4] 0 0
South Dakota
Country [5] 0 0
China
State/province [5] 0 0
Beijing
Country [6] 0 0
China
State/province [6] 0 0
Fujian
Country [7] 0 0
China
State/province [7] 0 0
Henan
Country [8] 0 0
China
State/province [8] 0 0
Hubei
Country [9] 0 0
China
State/province [9] 0 0
Jiangsu
Country [10] 0 0
China
State/province [10] 0 0
Jiangxi
Country [11] 0 0
China
State/province [11] 0 0
Liaoning
Country [12] 0 0
China
State/province [12] 0 0
Shandong
Country [13] 0 0
China
State/province [13] 0 0
Shanghai
Country [14] 0 0
China
State/province [14] 0 0
Tianjin
Country [15] 0 0
China
State/province [15] 0 0
Zhejiang
Country [16] 0 0
New Zealand
State/province [16] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BeiGene
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Director
Address 0 0
Country 0 0
Phone 0 0
+1-877-828-5568
Email 0 0
clinicaltrials@beigene.com
Contact person for scientific queries

Data sharing statement


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