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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
Date last updated
26/10/2024

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)
Timepoint [1] 0 0
Up to approximately four years
Primary outcome [2] 0 0
Number of participants with adverse events (AEs)
Timepoint [2] 0 0
Up to approximately four years
Primary outcome [3] 0 0
Number of participants with Tumor Lysis Syndrome (TLS)
Timepoint [3] 0 0
Up to approximately four years
Secondary outcome [1] 0 0
Maximum observed plasma concentration (Cmax) of BGB-21447
Timepoint [1] 0 0
Up to approximately four years
Secondary outcome [2] 0 0
Pre-dose trough concentration (Ctrough) of BGB-21447
Timepoint [2] 0 0
Up to approximately four years
Secondary outcome [3] 0 0
Area under the curve from time 0 to the last sampling time point within the dose interval (AUClast) of BGB-21447
Timepoint [3] 0 0
Up to approximately four years
Secondary outcome [4] 0 0
Area under the curve from time 0 extrapolated to infinity (AUCinf) of BGB-21447
Timepoint [4] 0 0
Up to approximately four years
Secondary outcome [5] 0 0
Time to reach maximum observed plasma concentration (Tmax) of BGB-21447
Timepoint [5] 0 0
Up to approximately four years
Secondary outcome [6] 0 0
Apparent terminal elimination half life (t1/2) of BGB-21447
Timepoint [6] 0 0
Up to approximately four years
Secondary outcome [7] 0 0
Apparent oral clearance (CL/F) of BGB-21447
Timepoint [7] 0 0
Up to approximately four years
Secondary outcome [8] 0 0
Apparent volume of distribution (Vz/F) of BGB-21447
Timepoint [8] 0 0
Up to approximately four years
Secondary outcome [9] 0 0
Steady state maximum observed plasma concentration (Cmax) of BGB-21447
Timepoint [9] 0 0
Up to approximately four years
Secondary outcome [10] 0 0
Steady state pre-dose trough concentration (Ctrough) of BGB-21447
Timepoint [10] 0 0
Up to approximately four years
Secondary outcome [11] 0 0
Steady state area under the curve from time 0 to the last sampling time point within the dose interval (AUClast) of *drug name*
Timepoint [11] 0 0
Up to approximately four years
Secondary outcome [12] 0 0
Steady state area under the curve from time 0 extrapolated to infinity (AUCinf) of BGB-21447
Timepoint [12] 0 0
Up to approximately four years
Secondary outcome [13] 0 0
Steady state time to reach maximum observed plasma concentration (Tmax) of BGB-21447
Timepoint [13] 0 0
Up to approximately four years
Secondary outcome [14] 0 0
Steady state apparent terminal elimination half life (t1/2) of BGB-21447
Timepoint [14] 0 0
Up to approximately four years
Secondary outcome [15] 0 0
Steady state apparent oral clearance (CL/F) of BGB-21447
Timepoint [15] 0 0
Up to approximately four years
Secondary outcome [16] 0 0
Steady state apparent volume of distribution (Vz/F) of BGB-21447
Timepoint [16] 0 0
Up to approximately four years
Secondary outcome [17] 0 0
Overall response rate (ORR)
Timepoint [17] 0 0
Up to approximately four years
Secondary outcome [18] 0 0
Duration of Response (DOR)
Timepoint [18] 0 0
Up to approximately four years
Secondary outcome [19] 0 0
Time to response (TTR)
Timepoint [19] 0 0
Up to approximately four years
Secondary outcome [20] 0 0
Progression-free survival (PFS)
Timepoint [20] 0 0
Up to approximately four years

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 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)
VIC
Recruitment hospital [1] 0 0
Monash Health - Clayton
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
China
State/province [2] 0 0
Fujian
Country [3] 0 0
China
State/province [3] 0 0
Henan
Country [4] 0 0
China
State/province [4] 0 0
Hubei
Country [5] 0 0
China
State/province [5] 0 0
Jiangsu
Country [6] 0 0
China
State/province [6] 0 0
Jiangxi
Country [7] 0 0
China
State/province [7] 0 0
Liaoning
Country [8] 0 0
China
State/province [8] 0 0
Shandong
Country [9] 0 0
China
State/province [9] 0 0
Shanghai
Country [10] 0 0
China
State/province [10] 0 0
Tianjin

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

Ethics approval
Ethics application status

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."
Trial website
https://clinicaltrials.gov/study/NCT05828589
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BeiGene
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05828589