Trial Review

ANZCTR is currently experiencing a technical issue. Thank you for your patience while we work on it and apologies for any inconvenience caused.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date last updated
5/06/2025

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 and Dose-Optimization 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 A2.1): BGB-21447 Monotherapy Dose Optimization in R/R DLBCL - Participants will receive BGB-21447 with two dose levels from Cohort A1 for further evaluation of safety and efficacy.

Experimental: Part 2 (Cohort A2.2): BGB-21447 Monotherapy Dose Optimization in R/R FL or R/R MZL - Participants will receive BGB-21447 with 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)
Timepoint [1] 0 0
Up to approximately 1 month
Primary outcome [2] 0 0
Number of participants with adverse events (AEs)
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)
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
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
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
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
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
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
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
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
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
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
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
Timepoint [11] 0 0
Up to approximately 8 weeks
Secondary outcome [12] 0 0
Overall response rate (ORR)
Timepoint [12] 0 0
Up to approximately 24 months
Secondary outcome [13] 0 0
Duration of Response (DOR)
Timepoint [13] 0 0
Up to approximately 24 months
Secondary outcome [14] 0 0
Time to response (TTR)
Timepoint [14] 0 0
Up to approximately 24 months
Secondary outcome [15] 0 0
Progression-free survival (PFS)
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 (for Cohort A1 and Cohort A2.1)

* High-grade B-cell lymphomas with translocations of MYC and Bcl-2 and/or Bcl-6 are not allowed in Cohort A1 but may be allowed in Cohort A2.1
2. R/R FL (for Cohort A1 and Cohort A2.2)
3. R/R MZL (for Cohort A1 and Cohort A2.2)
4. Transformed B-cell NHL (for Cohort A1 only)
5. Richter's transformation to DLBCL (for Cohort A1 only)
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 or lentigo maligna melanoma that has been curatively resected
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
1/04/2027
Actual
Sample size
Target
112
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
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
South Dakota
Country [6] 0 0
China
State/province [6] 0 0
Beijing
Country [7] 0 0
China
State/province [7] 0 0
Fujian
Country [8] 0 0
China
State/province [8] 0 0
Henan
Country [9] 0 0
China
State/province [9] 0 0
Hubei
Country [10] 0 0
China
State/province [10] 0 0
Jiangsu
Country [11] 0 0
China
State/province [11] 0 0
Jiangxi
Country [12] 0 0
China
State/province [12] 0 0
Liaoning
Country [13] 0 0
China
State/province [13] 0 0
Shandong
Country [14] 0 0
China
State/province [14] 0 0
Shanghai
Country [15] 0 0
China
State/province [15] 0 0
Sichuan
Country [16] 0 0
China
State/province [16] 0 0
Tianjin
Country [17] 0 0
China
State/province [17] 0 0
Zhejiang
Country [18] 0 0
France
State/province [18] 0 0
Dijon
Country [19] 0 0
France
State/province [19] 0 0
Montpellier
Country [20] 0 0
France
State/province [20] 0 0
Paris
Country [21] 0 0
France
State/province [21] 0 0
Toulouse
Country [22] 0 0
Italy
State/province [22] 0 0
Bologna
Country [23] 0 0
Italy
State/province [23] 0 0
Napoli
Country [24] 0 0
Italy
State/province [24] 0 0
Rozzano
Country [25] 0 0
Italy
State/province [25] 0 0
Verona
Country [26] 0 0
New Zealand
State/province [26] 0 0
Auckland

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Fax 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
Fax 0 0
Email 0 0
[email protected]
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